dextromethorphan product · pdf filedextromethorphan product list. ... dextromethorphan hbr,...

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDC7-Eleven 7 select night time relief 8 BLISTER PACK in 1 CARTON

(10202-056-73) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate

10202-056

7-Eleven 7 select night time relief 354 mL in 1 BOTTLE (10202-335-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


10202-335

7-Eleven 7 select day time relief 354 mL in 1 BOTTLE (10202-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL

acetaminophen, dextromethorphan Hbr, Phenylephrine HCl

10202-656

7-Eleven 7 select day time relief 8 BLISTER PACK in 1 CARTON (10202-994-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

10202-994

7-Eleven 7 Select Cough DM 1 BOTTLE in 1 CARTON (10202-384-21) > 89 mL in 1 BOTTLE

30 mg/5mL dextromethorphan polistirex 10202-384

A&Z Holistic Products, Inc. Daytime Cold and Flu Relief 1 BLISTER PACK in 1 BOX (69619-303-10) > 10 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI

69619-303

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Dextromethorphan Product List

Information to create this list was taken from the Federal Food and Drug Administrations's National Drug Code Directory. If reviewing the list on the FDA’s page, please use the search criteria Nonproprietary Name, and Dextromethorphan.

A

DOH 690-292 May 2016 2 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAAA Pharmaceutical, Inc. Acetaminophen, Chlorpheniramine Maleate,

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

2 BLISTER PACK in 1 CARTON (57344-139-02) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

57344-139

AAA Pharmaceutical, Inc. Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride


325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


57344-161

AAA Pharmaceutical, Inc. Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride


325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

57344-134



325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


57344-134

DOH 690-292 May 2016 3 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAAA Pharmaceutical, Inc. Acetaminophen, Dextromethorphan Hydrobromide,

Guaifenesin, Phenylephrine Hydrochloride2 BLISTER PACK in 1 CARTON (57344-136-02) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


57344-136



325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


57344-163



325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


57344-163



325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride

57344-159

AAA Pharmaceutical, Inc. Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride


325 mg/1, 10 mg/1, 5 mg/1 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

57344-160

DOH 690-292 May 2016 4 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAAA Pharmaceutical, Inc. Acetaminophen, Dextromethorphan Hydrobromide,

Phenylephrine Hydrochloride2 BLISTER PACK in 1 CARTON (57344-138-02) > 12 TABLET, COATED in 1 BLISTER PACK


57344-138

AAA Pharmaceutical, Inc. Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride



57344-138

AAFES/Your Military Exchanges Nite Time Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (55301-344-12)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

55301-344

AAFES/Your Military Exchanges Cold and Flu Relief 355 mL in 1 BOTTLE, PLASTIC (55301-043-12)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55301-043

AAFES/Your Military Exchanges Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (55301-336-06)

650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

55301-336

AAFES/Your Military Exchanges Daytime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (55301-066-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

55301-066

DOH 690-292 May 2016 5 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAAFES/Your Military Exchanges Severe cold and cough relief 245 mL in 1 BOTTLE, PLASTIC

(55301-316-08)650 mg/30mL, 20 mg/30mL, 10 mg/30mL


55301-316

AAFES/Your Military Exchanges Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (55301-384-04) > 118 mL in 1 BOTTLE,PLASTIC

10 mg/5mL, 100 mg/5mL Dextromethorphan HBr, Guaifenesin

55301-384

AAFES/Your Military Exchanges Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (55301-385-08) > 237 mL in 1 BOTTLE,PLASTIC


55301-385

AAFES/Your Military Exchanges Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (55301-337-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL

Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

55301-337

AAFES/Your Military Exchanges Tussin Multi Symptom Cold CF 1 BOTTLE, PLASTIC in 1 BOX (55301-382-08) > 237 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL

Dextromethorphan HBr, Guaifenesin, Phenylephrine

55301-382

Aaron Industries Inc Tussin Cough Long Acting 118 mL in 1 BOTTLE, PLASTIC (49580-3412-4)

10 mg/5mL Robitussin Cough Long Acting 49580-3412

Aaron Industries Inc Tussin CF 118 mL in 1 BOTTLE, PLASTIC (49580-0126-4)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL

Robitussin CF 49580-0126

Aaron Industries Inc. Night time cold and flu 355 mL in 1 BOTTLE, PLASTIC (49580-0342-2)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49580-0342

Aaron Industries Inc. Nighttime Cold and Flu 177 mL in 1 BOTTLE, PLASTIC (49580-0344-6)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49580-0344

DOH 690-292 May 2016 6 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAaron Industries Inc. Day Time Cold and Flu 296 mL in 1 BOTTLE, PLASTIC

(49580-0311-1)325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49580-0311

Aaron Industries Inc. Nighttime Cough 296 mL in 1 BOTTLE (49580-0345-1) 30 mg/30mL, 12.5 mg/30mL

Dextromethorphan Hydrobromide, Doxylamine Succinate

49580-0345

Aaron Industries Inc. Tussin DM Cough and Chest Congestion 1 BOTTLE, PLASTIC in 1 BOX (49580-0384-4) > 118 mL in 1 BOTTLE, PLASTIC


49580-0384

Aaron Industries Inc. Tussin DM Cough and Chest Congestion 1 BOTTLE, PLASTIC in 1 BOX (49580-0385-4) > 118 mL in 1 BOTTLE, PLASTIC


49580-0385

Aaron Industries, Inc. Childrens Plus Multi-Symptom Cold Grape 118 mL in 1 BOTTLE, PLASTIC (49580-1434-4)

160 mg/5mL, 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL

Childrens Tylenol Plus Multi-Symptom Cold

49580-1434

Aaron Industries, Inc. Night Time Cherry 177 mL in 1 BOTTLE, PLASTIC (49580-1403-4)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

NyQuil Cherry 49580-1403

Aaron Industries, Inc. Night Time Original 177 mL in 1 BOTTLE, PLASTIC (49580-1406-6)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49580-1406

Aaron Industries, Inc. Day Time 296 mL in 1 BOTTLE, PLASTIC (49580-3416-1)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

DayQuil 49580-3416

Aaron Industries, Inc. Day Time with PE 296 mL in 1 BOTTLE, PLASTIC (49580-0142-1)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49580-0142

Aaron Industries, Inc. Flu Relief Therapy Day Time 237 mL in 1 BOTTLE, PLASTIC (49580-0155-8)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Theraflu Daytime 49580-0155

DOH 690-292 May 2016 7 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAaron Industries, Inc. Day Time Cold Multi-Symptom Cool Blast 237 mL in 1 BOTTLE, PLASTIC

(49580-0192-8)325 mg/5mL, 200 mg/5mL, 10 mg/5mL, 5 mg/5mL

Tylenol Multi Symptom Cool Blast Daytime

49580-0192

Aaron Industries, Inc. DiBromm DM 118 mL in 1 BOTTLE, PLASTIC (59779-987-26)

1 mg/5mL, 2.5 mg/5mL, 5 mg/5mL

BROMPHENIRAMINE MALEATE , PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE,

59779-987

Aaron Industries, Inc. Childrens Mucus Relief Cough Cherry 118 mL in 1 BOTTLE, PLASTIC (49580-0158-4)

5 mg/5mL, 100 mg/5mL Childrens Mucinex Cough 49580-0158

Aaron Industries, Inc. Childrens Mucus Relief Cough Cherry 118 mL in 1 BOTTLE, PLASTIC (49580-3304-4)

5 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

49580-3304

Access Business Group LLC fulton street market cold 1 BOTTLE in 1 CARTON (10056-903-26) > 118 mL in 1 BOTTLE


Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl

10056-903

Access Business Group LLC Fulton Street Market cold and flu 296 mL in 1 BOTTLE (10056-990-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

10056-990

Access Business Group LLC fulton street market night time cold and flu 355 mL in 1 BOTTLE (10056-872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


10056-872

Access Business Group LLC FormuCare Cough Syrup DM 1 BOTTLE in 1 CARTON (10056-359-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL Dextromethorphan Hydrobromide, Guaifenesin

10056-359

Accudial Pharmaceutical, Inc. Runny Nose and Cough 118 mL in 1 BOTTLE (45014-153-04) .5 mg/5mL, 5 mg/5mL, 1.25 mg/5mL

Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

45014-153

DOH 690-292 May 2016 8 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAccudial Pharmaceutical, Inc. Cough and Cold 118 mL in 1 BOTTLE (45014-151-04) 1 mg/5mL, 7.5 mg/5mL Chlorpheniramine Maleate and

Dextromethorphan Hydrobromide

45014-151

Accudial Pharmaceutical, Inc. Daytime Cough And Cold 118 mL in 1 BOTTLE (45014-152-04) 5 mg/5mL, 1.25 mg/5mL Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

45014-152

Accudial Pharmaceutical, Inc. Daytime Cough and Cold 118 mL in 1 BOTTLE (45014-158-04) 5 mg/5mL, 2.5 mg/5mL Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

45014-158

Acella Pharmaceuticals, LLC Entre-Cough 473 mL in 1 BOTTLE (42192-523-16) 15 mg/5mL, 175 mg/5mL, 30 mg/5mL

Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, Guaifensin

42192-523

Acme United Corporation PhysiciansCare Cold and Cough 50 PACKET in 1 CARTON (0924-0137-01) > 2 TABLET, FILM COATED in 1PACKET

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

0924-0137


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


0924-0137


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


0924-0140


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


0924-0140

DOH 690-292 May 2016 9 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCActipharma, Inc ACTIDOM DMX 474 mL in 1 BOTTLE, PLASTIC

(63102-110-16)30 mg/5mL, 200 mg/5mL, 10 mg/5mL

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

63102-110

ACTIPHARMA, INC ACTINEL 474 mL in 1 BOTTLE (63102-101-16) 15 mg/5mL, 200 mg/5mL, 30 mg/5mL

Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl

63102-101

ACTIPHARMA, INC ACTINEL PEDIATRIC 474 mL in 1 BOTTLE (63102-102-16) 5 mg/5mL, 50 mg/5mL, 15 mg/5mL

Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl

63102-102

Advanced Generic Corporation Bio T Pres-B 473 mL in 1 BOTTLE (45737-226-16) 4 mg/5mL, 20 mg/5mL, 10 mg/5mL

BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

45737-226

Advanced Generic Corporation BIO Dtuss 473 mL in 1 BOTTLE (45737-203-16) 1 mg/5mL, 20 mg/5mL, 30 mg/5mL

Brompheniramine Maleate, Dextromethorphan, Pseudoephedrine

45737-203

Advanced Generic Corporation BIO-RYTUSS 473 mL in 1 BOTTLE (45737-250-16) 2 mg/5mL, 10 mg/5mL, 5 mg/5mL

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

45737-250

Advanced Generic Corporation Bionatuss 473 mL in 1 BOTTLE (45737-210-16) 2 mg/5mL, 20 mg/5mL, 10 mg/5mL

Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine

45737-210

DOH 690-292 May 2016 10 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAdvanced Generic Corporation Bio-B Kids 473 mL in 1 BOTTLE (45737-218-16) 15 mg/5mL, 4 mg/5mL, 10

mg/5mLDextromethorphan,Chlorpheniramine Maleate, Phenylephrine

45737-218

Advanced Generic Corporation Biospec 473 mL in 1 BOTTLE (45737-211-16) 15 mg/5mL, 25 mg/5mL Dextromethorphan, Guaifenesin

45737-211

Advanced Generic Corporation Bio-Z-Cough 473 mL in 1 BOTTLE (45737-251-16) 20 mg/5mL, 400 mg/5mL Dextromethorphan Hydrobromide, Guaifenesin

45737-251

Advanced Generic Corporation Biospec 473 mL in 1 BOTTLE (45737-264-16) 10 mg/5mL, 187 mg/5mL Dextromethorphan, Guaifenesin

45737-264

Advanced Generic Corporation Biocotron 473 mL in 1 BOTTLE (45737-261-16) 15 mg/5mL, 350 mg/5mL, 10 mg/5mL


45737-261

Advanced Generic Corporation Biodesp 473 mL in 1 BOTTLE (45737-263-16) 15 mg/5mL, 100 mg/5mL, 5 mg/5mL


45737-263

Advanced Generic Corporation BioTPres 473 mL in 1 BOTTLE (45737-227-16) 5 mg/5mL, 75 mg/5mL, 2.5 mg/5mL

Dextromethorphan, Guaifenesin, Phenylephrine

45737-227

Advanced Generic Corporation Bio-S-Pres 30 mL in 1 BOTTLE (45737-230-01) 5 mg/mL, 50 mg/mL, 2.5 mg/mL


45737-230

Advanced Generic Corporation BioGtuss 473 mL in 1 BOTTLE (45737-242-16) 28 mg/5mL, 388 mg/5mL, 10 mg/5mL


45737-242

Advanced Generic Corporation Biobron 473 mL in 1 BOTTLE (45737-246-16) 20 mg/5mL, 200 mg/5mL, 10 mg/5mL


45737-246

Advanced Generic Corporation Biocof 473 mL in 1 BOTTLE (45737-249-16) 20 mg/5mL, 400 mg/5mL, 10 mg/5mL

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HCL

45737-249

Advanced Generic Corporation Biobron 473 mL in 1 BOTTLE (45737-217-16) 15 mg/5mL, 350 mg/5mL, 10 mg/5mL


45737-217

DOH 690-292 May 2016 11 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAdvanced Generic Corporation Biocotron-D 473 mL in 1 BOTTLE (45737-208-16) 10 mg/5mL, 200 mg/5mL, 5

mg/5mLDextromethorphan HBr, Guaifenesin, Phenylephrine HCl

45737-208

Advanced Generic Corporation Biodesp 473 mL in 1 BOTTLE (45737-221-16) 15 mg/5mL, 100 mg/5mL, 5 mg/5mL


45737-221

Advanced Generic Corporation BioTPres 473 mL in 1 BOTTLE (45737-225-16) 15 mg/5mL, 200 mg/5mL, 5 mg/5mL


45737-225

Advanced Generic Corporation BioGtuss 473 mL in 1 BOTTLE (45737-205-16) 15 mg/5mL, 300 mg/5mL, 15 mg/5mL


45737-205

Advanced Generic Corporation Bionel 473 mL in 1 BOTTLE (45737-206-16) 15 mg/5mL, 200 mg/5mL, 30 mg/5mL

Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride

45737-206

Advanced Generic Corporation Bionel 473 mL in 1 BOTTLE (45737-207-16) 5 mg/5mL, 50 mg/5mL, 15 mg/5mL

Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride

45737-207

Advanced Generic Corporation Biogtuss 100 TABLET in 1 BOTTLE (45737-605-10)

388 mg/1, 10 mg/1, 28 mg/1

Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr

45737-605

Agile Pharmachem Acetaminophen,Dextromethorphan,Doxylamine 180 CARTON in 1 BLISTER PACK (58805-003-04) > 1 CAPSULE, LIQUID FILLED in 1 CARTON

325 mg/1, 10 mg/1, 6.25 mg/1

Acetaminophen,Dextromethorphan,Doxylamine

58805-003

Agile Pharmachem Acetaminophen,Dextromethorphan,Doxylamine 7680 CARTON in 1 BLISTER PACK (58805-003-14) > 1 CAPSULE, LIQUID FILLED in 1 CARTON

325 mg/1, 10 mg/1, 6.25 mg/1


58805-003

Agile Pharmachem Acetaminophen,Dextromethorphan,Phenylephrine 8 CARTON in 1 BLISTER PACK (58805-002-08) > 180 CAPSULE, LIQUID FILLED in 1 CARTON

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen,Dextromethorphan,Phenylephrine

58805-002

DOH 690-292 May 2016 12 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAgile Pharmachem Acetaminophen,Dextromethorphan,Phenylephrine 7680 CARTON in 1 BLISTER PACK

(58805-002-14) > 1 CAPSULE, LIQUID FILLED in 1 CARTON


58805-002

Agile Pharmachem Cough and Congestion DM 7500 CARTON in 1 CAPSULE (58805-007-75) > 1 CAPSULE, LIQUID FILLED in 1 CARTON

10 mg/1, 200 mg/1 Dextromethorphan and Guaifenesin

58805-007

AiPing Pharmaceutical Inc. Daytime Cold and Flu Relief 1 BLISTER PACK in 1 BOX (11788-303-06) > 10 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI

11788-303

AiPing Pharmaceutical, Inc. Nighttime Cold and Flu Relief 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (11788-304-06)

325 mg/1, 15 mg/1, 6.25 mg/1


11788-304

Allegiant Health Cold Multi-Symptom 12 TABLET in 1 BLISTER PACK (69168-319-86)

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1

Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI

69168-319

Allegiant Health Night Time Cold and Flue Relief 8 CAPSULE, LIQUID FILLED in 1 BOX (69168-357-29)

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan, Doxylamine succinate

69168-357

Allegiant Health Night Time Cold and Flue Relief 20 CAPSULE, LIQUID FILLED in 1 BOX (69168-357-51)

325 mg/1, 15 mg/1, 6.25 mg/1


69168-357

Allegiant Health Day Time Cold and FlueNon drowsy 8 CAPSULE, LIQUID FILLED in 1 BOX (69168-356-29)

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg

69168-356

Allegiant Health Day Time Cold and FlueNon drowsy 20 CAPSULE, LIQUID FILLED in 1 BOX (69168-356-51)


69168-356

DOH 690-292 May 2016 13 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAllegiant Health Cold Multi-Symptom 12 TABLET in 1 BLISTER PACK

(69168-323-86)325 mg/1, 200 mg/1, 10 mg/1, 5 mg/1

Acetaminophen,Guaifenesin, Dextromethorphan HBr and Phenylephrine HCI

69168-323

Allegiant Health Mucus Relief DMImmediate Release 10 TABLET in 1 CARTON (69168-345-07)

20 mg/1, 400 mg/1 Dextromethorphan HBr and Guaifenesin

69168-345

Allegiant Health Mucus Relief DMImmediate Release 20 TABLET in 1 CARTON (69168-345-26)


69168-345

Allegis Pharmaceuticals, LLC AP-Hist DM 473 mL in 1 BOTTLE (28595-800-16) 4 mg/mL, 7.5 mg/mL, 15 mg/mL

Brompheniramine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide

28595-800

Allegis Pharmaceuticals, LLC Duravent DM 60 TABLET in 1 BOTTLE (28595-906-60)

15 mg/1, 395 mg/1, 10 mg/1

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

28595-906

Allegis Pharmaceuticals, LLC HISTEX-DM 473 mL in 1 BOTTLE (28595-804-16) 20 mg/5mL, 10 mg/5mL, 2.5 mg/5mL

DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE

28595-804

Alternative Pharmacal Corporation Altipres-B 473 mL in 1 BOTTLE (53163-101-16) 4 mg/5mL, 20 mg/5mL, 10 mg/5mL


53163-101

DOH 690-292 May 2016 14 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAlternative Pharmacal Corporation Altituss 473 mL in 1 BOTTLE (53163-113-16) 15 mg/7.5mL, 150

mg/7.5mLDextromethorphan HBr, Guaifenesin

53163-113

Alternative Pharmacal Corporation Altipres 473 mL in 1 BOTTLE (53163-104-16) 10 mg/5mL, 200 mg/5mL, 5 mg/5mL


53163-104

Alternative Pharmacal Corporation Altidome 473 mL in 1 BOTTLE (53163-251-16) 30 mg/5mL, 200 mg/5mL, 10 mg/5mL


53163-251

Alternative Pharmacal Corporation Altipres 473 mL in 1 BOTTLE (53163-103-16) 5 mg/5mL, 75 mg/5mL, 2.5 mg/5mL


53163-103

Alternative Pharmacal Corporation Igualtuss 473 mL in 1 BOTTLE (53163-106-16) 28 mg/5mL, 388 mg/5mL, 10 mg/5mL


53163-106

Alternative Pharmacal Corporation Alticotron 60 mL in 1 BOTTLE (53163-107-02) 5 mg/mL, 100 mg/mL, 2.5 mg/mL


53163-107

Alternative Pharmacal Corporation Altidesp 30 mL in 1 BOTTLE (53163-108-01) 5 mg/mL, 50 mg/mL, 2.5 mg/mL


53163-108

Alternative Pharmacal Corporation Altilan 473 mL in 1 BOTTLE (53163-114-16) 15 mg/5mL, 10 mg/5mL, 4 mg/5mL

Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate

53163-114

American Sales Company Care One Cold Multi Symptom 2 BLISTER PACK in 1 CARTON (41520-014-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

41520-014

DOH 690-292 May 2016 15 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerican Sales Company Care One Cold Head Congestion 2 BLISTER PACK in 1 CARTON

(41520-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


41520-393

American Sales Company Cold Head Congestion Nighttime 2 BLISTER PACK in 1 CARTON (41520-598-02) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


41520-598

American Sales Company Cold Multi-Symptom Nighttime 2 BLISTER PACK in 1 CARTON (41520-599-02) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


41520-599

American Sales Company CareOne Night TIme Cold and Flu 355 mL in 1 BOTTLE (41520-084-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


41520-084

American Sales Company CareOne Nitetime Cold Flu Relief 237 mL in 1 BOTTLE (41520-335-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


41520-335



41520-335

DOH 690-292 May 2016 16 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerican Sales Company Night Time Original 177 mL in 1 BOTTLE, PLASTIC

(41520-112-06)500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41520-112

American Sales Company Night Time Cherry 177 mL in 1 BOTTLE, PLASTIC (41520-113-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate,

41520-113

American Sales Company Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (41520-114-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41520-114

American Sales Company CareOne Nighttime Cold and Flu 355 mL in 1 BOTTLE (41520-712-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


41520-712

American Sales Company CareOne Cold and Cough 237 mL in 1 BOTTLE (41520-666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

41520-666



41520-459



41520-459

American Sales Company Care One Cold Mutli Symptom 237 mL in 1 BOTTLE (41520-920-34) 325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL, 5 mg/15mL

acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl

41520-920

DOH 690-292 May 2016 17 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerican Sales Company CareOne Nitetime Severe Cold Flu Relief 355 mL in 1 BOTTLE (41520-763-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl

41520-763

American Sales Company CareOne Nighttime Severe Cold and Flu 355 mL in 1 BOTTLE (41520-561-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


41520-561

American Sales Company careone cold max 240 mL in 1 BOTTLE (41520-580-34) 325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL, 5 mg/15mL


41520-580

American Sales Company careone severe sinus congestion 10 BLISTER PACK in 1 CARTON (41520-345-26) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

41520-345

American Sales Company Care One cold head congestion 12 BLISTER PACK in 1 CARTON (41520-234-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41520-234

American Sales Company CareOne Mucus Relief 10 BLISTER PACK in 1 CARTON (41520-766-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41520-766

American Sales Company CareOne Mucus Relief 2 BLISTER PACK in 1 CARTON (41520-922-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41520-922

DOH 690-292 May 2016 18 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerican Sales Company CareOne Mucus Relief 10 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41520-381

American Sales Company careone daytime severe cold flu relief 355 mL in 1 BOTTLE (41520-511-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL

acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

41520-511

American Sales Company DAYTIME 2 BLISTER PACK in 1 CARTON (41520-473-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl

41520-473

American Sales Company DAYTIME 2 BLISTER PACK in 1 CARTON (41520-473-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41520-473

American Sales Company Cold Head Congestion Daytime 2 BLISTER PACK in 1 CARTON (41520-603-02) > 12 TABLET, COATED in 1 BLISTER PACK


41520-603

American Sales Company Care One Cold Head Congestion 2 BLISTER PACK in 1 CARTON (41520-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

41520-402

American Sales Company CareOne Daytime Cold Flu Relief 355 mL in 1 BOTTLE (41520-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41520-656

American Sales Company CareOne DayTime Cold and Flu 355 mL in 1 BOTTLE (41520-032-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41520-032

DOH 690-292 May 2016 19 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerican Sales Company care one flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1

CARTON (41520-096-91)650 mg/1, 20 mg/1, 10 mg/1


41520-096

American Sales Company CareOne Daytime Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (41520-330-06)

650 mg/1, 20 mg/1, 10 mg/1

Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL

41520-330

American Sales Company Care One Cold Multi Symptom 2 BLISTER PACK in 1 CARTON (41520-371-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


41520-371

American Sales Company Cold Multi-Symptom Daytime 2 BLISTER PACK in 1 CARTON (41520-138-05) > 12 TABLET, COATED in 1 BLISTER PACK


41520-138

American Sales Company Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC (41520-155-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41520-155

American Sales Company CareOne Childrens Cold and Cough 1 BOTTLE in 1 CARTON (41520-987-26) > 118 mL in 1 BOTTLE

1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL

Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl

41520-987

American Sales Company CareOne Cough DM 1 BOTTLE in 1 CARTON (41520-384-21) > 89 mL in 1 BOTTLE


American Sales Company CareOne Cough DM 1 BOTTLE in 1 CARTON (41520-958-21) > 89 mL in 1 BOTTLE


American Sales Company Tussin Cough Long Acting 118 mL in 1 BOTTLE, PLASTIC (41520-098-04)

10 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE

41520-098

DOH 690-292 May 2016 20 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerican Sales Company CareOne NiteTime Cough 237 mL in 1 BOTTLE (41520-995-34) 30 mg/30mL, 12.5

mg/30mLDextromethorphan HBr, Doxylamine succinate

41520-995

American Sales Company CareOne NiteTime Cough 355 mL in 1 BOTTLE (41520-995-40) 30 mg/30mL, 12.5 mg/30mL

Dextromethorphan HBr, Doxylamine succinate

41520-995

American Sales Company Night Time Cough Cherry 296 mL in 1 BOTTLE, PLASTIC (41520-072-01)

15 mg/15mL, 135 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

41520-072

American Sales Company CareOne Adult Tussin DM 1 BOTTLE in 1 CARTON (41520-359-26) > 118 mL in 1 BOTTLE


41520-359



41520-359

American Sales Company Tussin Sugar Free Cough 118 mL in 1 BOTTLE, PLASTIC (41520-100-04)

10 mg/5mL, 100 mg/5mL Dextromethorphan Hydrobromide, GUAIFENESIN

41520-100

American Sales Company Tussin DM 118 mL in 1 BOTTLE, PLASTIC (41520-018-04)


41520-018



41520-578



41520-799



41520-799

American Sales Company careone childrens mucus relief 1 BOTTLE in 1 CARTON (41520-419-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL Dextromethorphan hbr, Guaifenesin

41520-419

American Sales Company CareOne Adult Tussin CF 1 BOTTLE in 1 CARTON (41520-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

41520-516

American Sales Company CareOne Adult Tussin CF 1 BOTTLE in 1 CARTON (41520-516-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


41520-516

DOH 690-292 May 2016 21 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerican Sales Company CareOne Childrens Mucus Relief 1 BOTTLE in 1 CARTON (41520-839-

26) > 118 mL in 1 BOTTLE5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL

dextromethorphan HBr, guaifenesin, phenylephrine HCl

41520-839

American Sales Company Tussin CF 118 mL in 1 BOTTLE, PLASTIC (41520-126-04)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


41520-126

Amerisource Bergen good neighbor pharmacy cold 2 BLISTER PACK in 1 CARTON (24385-076-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


24385-076

Amerisource Bergen good neighbor pharmacy cold head congestion 2 BLISTER PACK in 1 CARTON (24385-195-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


24385-195

Amerisource Bergen good neighbor pharmacy cold 1 BOTTLE in 1 CARTON (24385-984-26) > 118 mL in 1 BOTTLE



24385-984

Amerisource Bergen good neighbor pharmacy childrens pain relief plus 1 BOTTLE in 1 CARTON (24385-986-26) > 118 mL in 1 BOTTLE

160 mg/5mL, 5 mg/5mL Acetaminophen, Dextromethorphan HBr

24385-986

Amerisource Bergen good neighbor pharmacy multi symptom 237 mL in 1 BOTTLE (46122-277-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


46122-277

DOH 690-292 May 2016 22 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisource Bergen Good Neighbor Pharmacy Night Time 12 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


46122-245

Amerisource Bergen good neighbor pharmacy night time 237 mL in 1 BOTTLE (46122-136-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


46122-136



46122-136



46122-198



46122-198



46122-198



46122-198

Amerisource Bergen Good Neighbor Pharmacy Night Time 355 mL in 1 BOTTLE (46122-215-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


46122-215


acetaminophen, dextromethorphan hydrobromide and doxylamine succinate

46122-008

DOH 690-292 May 2016 23 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisource Bergen good neighbor pharmacy Night time 177 mL in 1 BOTTLE (24385-203-30) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mLacetaminophen, dextromethorphan hydrobromide and doxylamine succinate

24385-203

Amerisource Bergen good neighbor pharmacy Night time 296 mL in 1 BOTTLE (24385-203-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


24385-203


acetaminophen,dextromethorphan HBr, doxylamine succinate

24385-316



24385-316

Amerisource Bergen good neighbor pharmacy cough and sore throat 237 mL in 1 BOTTLE (24385-135-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


24385-135

Amerisource Bergen good neighbor pharmacy night time 2 BLISTER PACK in 1 CARTON (24385-035-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


24385-035

Amerisource Bergen good neighbor pharmacy severe sinus congestion 10 BLISTER PACK in 1 CARTON (46122-272-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


46122-272

Amerisource Bergen Good Neighbor Pharmacy Night Time Severe 237 mL in 1 BOTTLE (46122-233-34) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


46122-233

DOH 690-292 May 2016 24 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisource Bergen Good Neighbor Pharmacy Cold Multi Symptom 237 mL in 1 BOTTLE (46122-298-34) 325 mg/15mL, 10

mg/15mL, 6.25 mg/15mL, 5 mg/15mL


46122-298

Amerisource Bergen Good Neighbor pharmacy severe night time 237 mL in 1 BOTTLE (46122-300-34) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL

Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl

46122-300

Amerisource Bergen good neighbor pharmacy severe night time 12 BLISTER PACK in 1 CARTON (46122-301-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1

acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl

46122-301

Amerisource Bergen Good Neighbor Pharmacy Night Time D 296 mL in 1 BOTTLE (24385-322-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Pseudoephedrine HCl

24385-322

Amerisource Bergen Good Neighbor Pharmacy Night Time D 296 mL in 1 BOTTLE (24385-305-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride

24385-305

AmeriSource Bergen Cold Relief Multi-Symptom Severe 2 BLISTER PACK in 1 CARTON (46122-072-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


46122-072

DOH 690-292 May 2016 25 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisource Bergen Good Neighbor Pharmacy Mucus Relief Severe Cold 10 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


46122-295

Amerisource Bergen Good Neighbor Pharmacy Day Time Severe 237 mL in 1 BOTTLE (46122-234-34) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


46122-234

Amerisource Bergen Good neighbor pharmacy mucus relief 2 BLISTER PACK in 1 CARTON (46122-192-60) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


46122-192

Amerisource Bergen Good Neighbor Pharmacy Mucus Relief 2 BLISTER PACK in 1 CARTON (46122-193-60) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


46122-193

AmeriSource Bergen Cold Relief Cold and Flu Severe 2 BLISTER PACK in 1 CARTON (46122-230-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


46122-230

Amerisource Bergen Good Neighbor Pharmacy Severe Day Time 12 BLISTER PACK in 1 CARTON (46122-232-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl

46122-232

DOH 690-292 May 2016 26 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmeriSource Bergen Cold Relief Head Congestion Severe 2 BLISTER PACK in 1 CARTON

(46122-126-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


46122-126

Amerisource Bergen good neighbor pharmacy cold 2 BLISTER PACK in 1 CARTON (24385-542-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


24385-542

Amerisource Bergen good neighbor pharmacy cold 2 BLISTER PACK in 1 CARTON (24385-066-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


24385-066

Amerisource Bergen good neighbor pharmacy day time 12 BLISTER PACK in 1 CARTON (24385-036-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


24385-036

Amerisource Bergen Good Neighbor Pharmacy Cold 2 BLISTER PACK in 1 CARTON (24385-052-62) > 12 TABLET in 1 BLISTER PACK


24385-052

Amerisource Bergen Good Neighbor Pharmacy Day Time 177 mL in 1 BOTTLE (24385-005-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


24385-005



24385-005



24385-005

DOH 690-292 May 2016 27 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisource Bergen Good Neighbor Pharmacy Day Time 355 mL in 1 BOTTLE (24385-005-40) 325 mg/15mL, 10

mg/15mL, 5 mg/15mLacetaminophen, dextromethorphan Hbr, Phenylephrine HCl

24385-005

Amerisource Bergen Good Neighbor Pharmacy Cold 2 BLISTER PACK in 1 CARTON (24385-197-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


24385-197

AmeriSource Bergen Cold Relief Multi-Symptom Daytime 2 BLISTER PACK in 1 BLISTER PACK (46122-073-62) > 12 TABLET, COATED in 1 BLISTER PACK


46122-073

Amerisource Bergen good neighbor pharmacy flu and severe cold and cough

6 POWDER, FOR SOLUTION in 1 CARTON (46122-022-13)

650 mg/1, 20 mg/1, 10 mg/1


46122-022

Amerisource Bergen good neighbor pharmacy cold and cough 1 BOTTLE in 1 CARTON (24385-519-26) > 118 mL in 1 BOTTLE



24385-519

Amerisource Bergen Good Neighbor Pharmacy Tussin 1 BOTTLE in 1 CARTON (24385-493-26) > 118 mL in 1 BOTTLE

30 mg/10mL Dextromethorphan Hydrobromide

24385-493

Amerisource Bergen Good Neighbor Pharmacy Cough 1 BOTTLE in 1 CARTON (46122-293-21) > 89 mL in 1 BOTTLE


Amerisource Bergen Good Neighbor Pharmacy Cough DM ER 1 BOTTLE in 1 CARTON (46122-294-21) > 89 mL in 1 BOTTLE

30 mg/5mL Dextromethorphan polistirex 46122-294





DOH 690-292 May 2016 28 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisource Bergen Good Neighbor Pharmacy Cough DM ER 1 BOTTLE in 1 CARTON (46122-142-

21) > 89 mL in 1 BOTTLE30 mg/5mL dextromethorphan polistirex 46122-142

Amerisource Bergen Good Neighbor Pharmacy night time 177 mL in 1 BOTTLE (24385-461-30) 15 mg/15mL, 6.25 mg/15mL


24385-461



24385-461



24385-461



24385-461

Amerisource Bergen good neighbor pharmacy tussin dm 1 BOTTLE in 1 CARTON (24385-578-26) > 118 mL in 1 BOTTLE


24385-578

Amerisource Bergen Good Neighbor Pharmacy Tussin dm 1 BOTTLE in 1 CARTON (24385-359-26) > 118 mL in 1 BOTTLE


24385-359

Amerisource Bergen Good Neighbor Pharmacy Tussin dm 1 BOTTLE in 1 CARTON (24385-359-34) > 237 mL in 1 BOTTLE


24385-359

Amerisource Bergen good neighbor pharmacy tussin dm max 1 BOTTLE in 1 CARTON (46122-139-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 400 mg/10mL dextromethorphan hbr, guaifenesin

46122-139

Amerisource Bergen good neighbor pharmacy tussin dm max 1 BOTTLE in 1 CARTON (46122-139-34) > 237 mL in 1 BOTTLE


46122-139

Amerisource Bergen Good Neighbor Pharmacy tussin dm max 1 BOTTLE in 1 CARTON (46122-017-34) > 237 mL in 1 BOTTLE


46122-017

Amerisource Bergen good neighbor pharmacy day time 296 mL in 1 BOTTLE (46122-032-38) 10 mg/15mL, 200 mg/15mL Dextromethorphan HBr, Guaifenesin

46122-032

DOH 690-292 May 2016 29 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisource Bergen good neighbor pharmacy tussin cf max 1 BOTTLE in 1 CARTON (46122-138-

26) > 118 mL in 1 BOTTLE10 mg/5mL, 200 mg/5mL, 5 mg/5mL

dextromethorphan hbr, guaifenesin, phenylephrine hcl

46122-138

Amerisource Bergen good neighbor pharmacy tussin cf max 1 BOTTLE in 1 CARTON (46122-138-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


46122-138

Amerisource Bergen good neighbor pharmacy childrens mucus relief 1 BOTTLE in 1 CARTON (46122-235-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


46122-235

Amerisource Bergen Good Neighbor Pharmacy Tussin CF 1 BOTTLE in 1 CARTON (24385-904-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


24385-904

Amerisource Bergen Good Neighbor Pharmacy Tussin CF 1 BOTTLE in 1 CARTON (24385-904-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


24385-904

AmerisourceBergen (Good Neighbor Night time 2 BLISTER PACK in 1 CARTON (46122-183-73) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


46122-183

AmerisourceBergen (Good Neighbor Day time 2 BLISTER PACK in 1 CARTON (46122-184-73) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


46122-184

AmerisourceBergen (Good Neighbor Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (46122-310-26) > 118 mL in 1 BOTTLE,PLASTIC


Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride

46122-310

DOH 690-292 May 2016 30 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisourceBergen (Good Neighbor Cold and Flu Relief 16 BLISTER PACK in 1 CARTON

(46122-326-73) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

46122-326

AmerisourceBergen (Good Neighbor Nighttime Cold Multi-Symptom 237 mL in 1 BOTTLE, PLASTIC (46122-034-34)

325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl

46122-034

AmerisourceBergen (Good Neighbor Severe Cold and Cough Relief 245 mL in 1 BOTTLE, PLASTIC (46122-336-33)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL

ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL

46122-336

AmerisourceBergen (Good Neighbor Cold Flu Relief 16 BLISTER PACK in 1 CARTON (46122-339-73) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


46122-339

AmerisourceBergen (Good Neighbor Flu Relief Therapy 245 mL in 1 BOTTLE, PLASTIC (46122-015-33)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


46122-015

AmerisourceBergen (Good Neighbor Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (46122-324-26) > 118 mL in 1 BOTTLE,PLASTIC

15 mg/5mL Dextromethorphan HBr 46122-324

AmerisourceBergen (Good Neighbor Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (46122-303-30)



46122-303

AmerisourceBergen (Good Neighbor Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (46122-305-30)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


46122-305

DOH 690-292 May 2016 31 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAmerisourceBergen (Good Neighbor Triacting Day Time Cold and Cough 1 BOTTLE, PLASTIC in 1 BOX (46122-

327-26) > 118 mL in 1 BOTTLE,PLASTIC

5 mg/5mL, 2.5 mg/5mL Dextromethorphan HBr, Phenylephrine HCl

46122-327

AmerisourceBergen Drug Corp Good Neighbor Pharmacy Mucus Relief DM 1 BOTTLE, PLASTIC in 1 CARTON (24385-026-71) > 50 TABLET in 1 BOTTLE, PLASTIC

20 mg/1, 400 mg/1 Dextromethorphan Hydrobromide / Guaifenesin

24385-026

AmerisourceBergen Drug Corp Good Neighbor Pharmacy Tab Tussin DM 2 BLISTER PACK in 1 CARTON (46122-058-62) > 12 TABLET in 1 BLISTER PACK


46122-058

AmerisourceBergen Drug Corporatio Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (24385-262-26) > 118 mL in 1 BOTTLE,PLASTIC


AmerisourceBergen Drug Corporatio Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (24385-263-26) > 118 mL in 1 BOTTLE,PLASTIC


AmerisourceBergen Drug Corporatio Childrens Mucus Relief 1 BOTTLE, PLASTIC in 1 BOX (24385-985-26) > 118 mL in 1 BOTTLE,PLASTIC

5 mg/5mL, 100 mg/5mL Dextromethorphan HBr, Guaifensin

24385-985

AmerisourceBergen Drug Corporatio Triacting Daytime Cold Cough 1 BOTTLE, PLASTIC in 1 BOX (24385-981-26) > 118 mL in 1 BOTTLE,PLASTIC


24385-981

ARMY AND AIR FORCE EXCHANGE SECold and Flu Relief 2 BLISTER PACK in 1 CARTON (55301-660-08) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55301-660


325 mg/1, 15 mg/1, 6.25 mg/1


55301-535

DOH 690-292 May 2016 32 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCARMY AND AIR FORCE EXCHANGE SECold, Flu and Sore Throat 2 BLISTER PACK in 1 PACKAGE


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55301-618

ARMY AND AIR FORCE EXCHANGE SEDaytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (55301-534-08) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55301-534



55301-659

ARMY AND AIR FORCE EXCHANGE SECold Multi-Symptom 2 BLISTER PACK in 1 CARTON (55301-560-08) > 12 TABLET in 1 BLISTER PACK


55301-560

ARMY AND AIR FORCE EXCHANGE SECough and Cold HBP 2 BLISTER PACK in 1 CARTON (55301-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK

4 mg/1, 30 mg/1 Chlorpheniramine maleate, Dextromethorphan HBr

55301-411

ARMY AND AIR FORCE EXCHANGE SEAdult Tussin Cough Gels 1 BOTTLE in 1 PACKAGE (55301-442-09) > 20 CAPSULE, GELATINCOATED in 1 BOTTLE

15 mg/1 Dextromethorphan HBr 55301-442

ARMY AND AIR FORCE EXCHANGE SETussin Cough Gels 1 BOTTLE in 1 PACKAGE (55301-661-09) > 20 CAPSULE, LIQUID FILLED in1 BOTTLE


ARMY AND AIR FORCE EXCHANGE SEMucus Relief DM 3 BLISTER PACK in 1 CARTON (55301-533-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK


55301-533

A-S Medication Solutions Mucinex DM 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (54569-5986-0)

600 mg/1, 30 mg/1 Guaifenesin and Dextromethorphan Hydrobromide

54569-5986

DOH 690-292 May 2016 33 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCA-S Medication Solutions Mucinex DM 40 TABLET, EXTENDED RELEASE in 1

BOTTLE (54569-5987-0)600 mg/1, 30 mg/1 Guaifenesin and


54569-5987

A-S Medication Solutions LLC Delsym 1 BOTTLE in 1 CARTON (54569-1051-0) > 90 mL in 1 BOTTLE

30 mg/5mL Dextromethorphan 54569-1051

A-S Medication Solutions LLC Q Tussin DM 120 mL in 1 BOTTLE, PLASTIC (54569-3177-0)

10 mg/5mL, 100 mg/5mL Dextromethorphan HBr and Guaifenesin

54569-3177

ASSURED / DOLLAR TREE (GreenbrierMucus Relief DM 1 BOTTLE, PLASTIC in 1 BOX (33992-0109-1) > 15 TABLET, COATED in 1 BOTTLE, PLASTIC

20 mg/1, 400 mg/1 Dextromethorphan Hydrobromide and Guaifenesin

33992-0109

Atlantic Biologicals Corps Delsym (Dextromethorphan) 10 mL in 1 CUP (17856-0276-1) 30 mg/5mL Dextromethorphan 17856-0276Atlantic Biologicals Corps Tussin Sugar Free Cough 10 mL in 1 CUP (17856-5180-1) 10 mg/5mL, 100 mg/5mL Dextromethorphan

Hydrobromide, GUAIFENESIN17856-5180

Atlantic Biologicals Corps Tussin Sugar Free Cough 5 mL in 1 CUP (17856-5180-2) 10 mg/5mL, 100 mg/5mL Dextromethorphan Hydrobromide, GUAIFENESIN

17856-5180

Atlantic Biologicals Corps Robafen DM Cough Sugar Free Clear 5 mL in 1 CUP (17856-6306-5) 100 mg/5mL, 10 mg/5mL Guaifenesin and Dextromethorphan Hydrobromide

17856-6306

Aurohealth LLC AuroQuil COLD and FLU Nighttime Relief 355 mL in 1 BOTTLE (58602-136-16) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr

58602-136



58602-136



58602-136

DOH 690-292 May 2016 34 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAurohealth LLC AuroQuil Cold and Flu Nighttime Relief 177 mL in 1 BOTTLE (58602-137-18) 650 mg/30mL, 30

mg/30mL, 12.5 mg/30mLAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr

58602-137

Aurohealth LLC AuroQuil Cold and Flu Nighttime Relief 237 mL in 1 BOTTLE (58602-137-20) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


58602-137

Aurohealth LLC AuroQuil Cold and Flu Nighttime Relief 2 BOTTLE in 1 CARTON (58602-137-35) > 355 mL in 1 BOTTLE (58602-137-16)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


58602-137

Aurohealth LLC AuroQuil Severe Cold and Flu Nighttime Relief 354 mL in 1 BOTTLE (58602-148-16) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL

acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr

58602-148

Aurohealth LLC AuroQuil Severe Cold and Flu Nighttime Relief 237 mL in 1 BOTTLE (58602-148-20) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL

acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr

58602-148

Aurohealth LLC Aurophen Cold Multi Symptom 1 BOTTLE in 1 CARTON (58602-127-20) > 240 mL in 1 BOTTLE


acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride

58602-127

Aurohealth LLC Aurophen Cold Multi-Symptom Severe 1 BOTTLE in 1 CARTON (58602-128-20) > 240 mL in 1 BOTTLE


acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

58602-128

DOH 690-292 May 2016 35 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAurohealth LLC AuroMucus - Fast Maximum Cold, Flu and Sore Throat

Relief180 mL in 1 BOTTLE (58602-110-18) 650 mg/20mL, 20

mg/20mL, 400 mg/20mL, 10 mg/20mL

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride

58602-110

Aurohealth LLC AuroMucus - Fast Maximum Cold, Flu and Sore Throat Relief

266 mL in 1 BOTTLE (58602-110-21) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


58602-110

Aurohealth LLC AuroQuil Severe Cold and Flu Daytime Relief 354 mL in 1 BOTTLE (58602-149-16) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL

acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin

58602-149

Aurohealth LLC AuroQuil Severe Cold and Flu Daytime Relief 237 mL in 1 BOTTLE (58602-149-20) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


58602-149

Aurohealth LLC Aurophen Cold and Flu Severe 1 BOTTLE in 1 CARTON (58602-123-20) > 240 mL in 1 BOTTLE


acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

58602-123

Aurohealth LLC Auro Mucus - Childrens Cold, Cough and Sore Throat 118 mL in 1 BOTTLE (58602-157-24) 325 mg/10mL, 10 mg/10mL, 200 mg/10mL, 5 mg/10mL


58602-157

DOH 690-292 May 2016 36 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAurohealth LLC AuroFlu Day Time Severe Cold and Cough Warming

Relief245 mL in 1 BOTTLE (58602-124-33) 325 mg/15mL, 10

mg/15mL, 5 mg/15mLAcetaminophen, Dextromethorphan HBr and Phenylephrine HCl

58602-124

Aurohealth LLC AuroQuil COLD and FLU Day Time Multi-Symptom Relief

354 mL in 1 BOTTLE (58602-125-16) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Phenylephrine HCl, and Dextromethorphan HBr

58602-125




58602-125




58602-125

Aurohealth LLC Aurophen Cold Multi Symptom 1 BOTTLE in 1 CARTON (58602-130-20) > 240 mL in 1 BOTTLE

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

58602-130

Aurohealth LLC AuroQuil Cough Nighttime Cough Relief 354 mL in 1 BOTTLE (58602-132-16) 30 mg/30mL, 12.5 mg/30mL

Dextromethorphan HBr and Doxylamine succinate

58602-132



58602-132



58602-132

Aurohealth LLC Adult Aurotussin Maximum Strength Nighttime Cough DM

1 BOTTLE in 1 CARTON (58602-159-24) > 118 mL in 1 BOTTLE

30 mg/10mL, 12.5 mg/10mL

Dextromethorphan HBr, Doxylamine Succinate

58602-159

Aurohealth LLC AuroMucus - Fast Maximum DM MAX 180 mL in 1 BOTTLE (58602-151-18) 20 mg/20mL, 400 mg/20mL Dextromethorphan Hydrobromide and Guaifenesin

58602-151

DOH 690-292 May 2016 37 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAurohealth LLC AuroMucus - Fast Maximum DM MAX 266 mL in 1 BOTTLE (58602-151-21) 20 mg/20mL, 400 mg/20mL Dextromethorphan

Hydrobromide and Guaifenesin58602-151

Aurohealth LLC Childrens Aurotussin Cough and Chest Congestion DM 1 BOTTLE in 1 CARTON (58602-153-24) > 118 mL in 1 BOTTLE


58602-153

Aurohealth LLC AuroMucus - Childrens Cough 1 BOTTLE in 1 CARTON (58602-106-24) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL Dextromethorphan Hydrobromide and Guaifenesin

58602-106

Aurohealth LLC Aurotussin Peak Cold Cough plus Chest Congestion DM 1 BOTTLE in 1 CARTON (58602-115-16) > 354 mL in 1 BOTTLE


58602-115



58602-115



58602-115

Aurohealth LLC Aurotussin Peak Cold Maximum Strength Cough plus Chest Congestion DM



58602-116




58602-116




58602-116

Aurohealth LLC Aurotussin Peak Cold sugar-free COUGH PLUS CHEST CONGESTION DM



58602-118




58602-118




58602-118

DOH 690-292 May 2016 38 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAurohealth LLC AuroMucus - Fast Maximum Severe Congestion and

Cough177 mL in 1 BOTTLE (58602-112-18) 20 mg/20mL, 400

mg/20mL, 10 mg/20mLDextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride

58602-112

Aurohealth LLC AuroMucus - Fast Maximum Severe Congestion and Cough


Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride

58602-112

Aurohealth LLC AuroMucus - Childrens Multi-Symptom Cold 1 BOTTLE in 1 CARTON (58602-138-24) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


58602-138

Aurohealth LLC Aurotussin Peak Cold Maximum Strength Multi-Symptom Cold


20 mg/10mL, 400 mg/10mL, 10 mg/10mL

Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL

58602-143

Aurohealth LLC Aurotussin Peak Cold Maximum Strength Multi-Symptom Cold


20 mg/10mL, 400 mg/10mL, 10 mg/10mL


58602-143

Aurohealth LLC Aurotussin Peak Cold Multi-Symptom Cold 1 BOTTLE in 1 CARTON (58602-144-20) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


58602-144

Aurohealth LLC Aurotussin Peak Cold Multi-Symptom Cold 1 BOTTLE in 1 CARTON (58602-144-24) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


58602-144

Aurohealth LLC Childrens Aurotussin Cough and Cold CF 1 BOTTLE in 1 CARTON (58602-154-24) > 118 mL in 1 BOTTLE

10 mg/10mL, 100 mg/10mL, 5 mg/10mL


58602-154

Aurohealth LLC Childrens Daytime Cold and Cough 1 BOTTLE in 1 CARTON (58602-145-24) > 118 mL in 1 BOTTLE

5 mg/5mL, 2.5 mg/5mL Dextromethorphan HBr, Phenylephrine hydrochloride

58602-145

DOH 690-292 May 2016 39 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCAvema Pharma Solutions Mucus Relief DM 30 TABLET, COATED in 1 BOTTLE,

PLASTIC (63548-6352-1)20 mg/1, 400 mg/1 Dextromethorphan


Ballay Pharmaceuticals, Inc. Balahist 473 mL in 1 BOTTLE (63162-520-16) 4 mg/5mL, 7.5 mg/5mL, 15 mg/5mL

Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

63162-520

Ballay Pharmaceuticals, Inc. Balamine 473 mL in 1 BOTTLE (63162-508-16) 2 mg/5mL, 5 mg/5mL, 10 mg/5mL

Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

63162-508

Ballay Pharmaceuticals, Inc. Balamine 6 BOTTLE in 1 TRAY (63162-508-20) > 20 mL in 1 BOTTLE

2 mg/5mL, 5 mg/5mL, 10 mg/5mL


63162-508

Bayer Corporation Consumer Care D Alka-Seltzer Plus 1 POUCH in 1 CARTON (0280-7050-20) > 20 TABLET, EFFERVESCENT in1 POUCH

250 mg/1, 2 mg/1, 5 mg/1, 10 mg/1

Acetaminophen, Chlorpheniramine maleate, Phenylephrine Hydrochloride, and Dextromethorphan hydrobromide

0280-7050

Bayer Corporation Consumer Care D Alka-Seltzer Plus 1 POUCH in 1 CARTON (0280-1180-20) > 20 CAPSULE, LIQUID FILLED in1 POUCH

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine Hydrochloride

0280-1180

B

DOH 690-292 May 2016 40 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBayer HealthCare Consumer Care Alka-Seltzer Plus Severe Sinus and Cold 6 PACKET in 1 CARTON (0280-0923-

06) > 1 POWDER, FOR SOLUTION in1 PACKET

650 mg/1, 4 mg/1, 20 mg/1, 10 mg/1


0280-0923

Bayer HealthCare Consumer Care Alka-Seltzer Plus Night Severe Cold and Flu 6 PACKET in 1 CARTON (0280-0922-06) > 1 POWDER, FOR SOLUTION in1 PACKET

650 mg/1, 20 mg/1, 12.5 mg/1, 10 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE

0280-0922

Bayer HealthCare Consumer Care Alka-Seltzer Plus Day Severe Cold Plus Flu 6 PACKET in 1 CARTON (0280-0921-06) > 1 POWDER, FOR SOLUTION in1 PACKET

500 mg/1, 20 mg/1, 400 mg/1, 10 mg/1


0280-0921

Bayer HealthCare Consumer Care Alka-Seltzer Plus Cold and Cough Formula 10 POUCH in 1 CARTON (0280-1420-20) > 2 TABLET, EFFERVESCENT in 1POUCH

325 mg/1, 2 mg/1, 10 mg/1, 7.8 mg/1

Aspirin, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE BITARTRATE

0280-1420

Bayer HealthCare Consumer Care Alka-Seltzer Plus Cold and Cough Formula 13 POUCH in 1 CARTON (0280-1420-26) > 2 TABLET, EFFERVESCENT in 1POUCH

325 mg/1, 2 mg/1, 10 mg/1, 7.8 mg/1

Aspirin, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE BITARTRATE

0280-1420

DOH 690-292 May 2016 41 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBayer HealthCare Consumer Care Alka-Seltzer Plus Night Cold 10 POUCH in 1 CARTON (0280-0052-

20) > 2 TABLET, EFFERVESCENT in 1POUCH

500 mg/1, 10 mg/1, 6.25 mg/1, 7.8 mg/1

Aspirin, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE BITARTRATE

0280-0052

Bayer HealthCare Consumer Care Alka-Seltzer Plus Night Cold 13 POUCH in 1 CARTON (0280-0052-26) > 2 TABLET, EFFERVESCENT in 1POUCH

500 mg/1, 10 mg/1, 6.25 mg/1, 7.8 mg/1

Aspirin, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE BITARTRATE

0280-0052

Bayer HealthCare LLC - Consumer Ca Alka-Seltzer Plus 1 POUCH in 1 CARTON (0280-7055-20) > 20 GRANULE, EFFERVESCENTin 1 POUCH

250 mg/1, 10 mg/1, 2 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride

0280-7055

Bayer HealthCare LLC - Consumer Ca Alka-Seltzer Plus 1 BLISTER PACK in 1 CARTON (0280-1435-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine hydrochloride

0280-1435

Bayer HealthCare LLC - Consumer Ca Alka-Seltzer Plus Day Severe Cold, Cough And Flu 6 PACKET in 1 CARTON (0280-1155-06) > 1 POWDER in 1 PACKET

650 mg/1, 20 mg/1, 10 mg/1

Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride

0280-1155

DOH 690-292 May 2016 42 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBayer HealthCare LLC - Consumer Ca Alka-Seltzer Plus 1 BLISTER PACK in 1 CARTON (0280-

1415-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride

0280-1415

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus 1 BLISTER PACK in 1 CARTON (0280-1121-10) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


0280-1121


325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


0280-1121


325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


0280-1121

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus Severe Sinus Congestion and Cough 1 BLISTER PACK in 1 CARTON (0280-1135-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride

0280-1135

DOH 690-292 May 2016 43 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBayer HealthCare LLC, Consumer Car Alka-Seltzer Plus 1 BLISTER PACK in 1 CARTON (0280-


325 mg/1, 10 mg/1, 2 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride

0280-1130

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold 1 BLISTER PACK in 1 CARTON (0280-1197-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 2 mg/1, 30 mg/1

Acetaminophen, Dextromethorphan hydrobromide, chlorpheniramine maleate, and pseudoephedrine Hydrochloride

0280-1197

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus 5000 CAPSULE, LIQUID FILLED in 1 DRUM (0280-1124-05)

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


0280-1124


325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


0280-1124

DOH 690-292 May 2016 44 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBayer HealthCare LLC, Consumer Car Alka-Seltzer Plus 2 BLISTER PACK in 1 CARTON (0280-


325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


0280-1125

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus Severe Cold, Mucus and Congestion 1 BLISTER PACK in 1 CARTON (0280-1159-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

250 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, guaifenesin, and Phenylephrine hydrochloride

0280-1159

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus Severe Cough Mucus and Congestion 2 BLISTER PACK in 1 CARTON (0280-0505-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

250 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Alka-Seltzer Plus Severe Cough Mucus and Congestion

0280-0505

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus Severe Sinus Cold and Cough 2 BLISTER PACK in 1 CARTON (0280-0507-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

250 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride

0280-0507

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus Day Cold and Flu 2 BLISTER PACK in 1 CARTON (0280-1134-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


0280-1134

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus 1600 POUCH in 1 CASE (0280-1410-32) > 2 TABLET, EFFERVESCENT in 1POUCH

325 mg/1, 10 mg/1, 7.8 mg/1

Aspirin, Dextromethorphan hydrobromide, and Phenylephrine bitartrate

0280-1410

DOH 690-292 May 2016 45 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBayer HealthCare LLC, Consumer Car Alka-Seltzer Plus 1600 POUCH in 1 CASE (0280-1430-

32) > 2 TABLET, EFFERVESCENT in 1POUCH

500 mg/1, 6.25 mg/1, 7.8 mg/1, 10 mg/1

Aspirin, Doxylamine succinate, Phenylephrine bitartrate, and Dextromethorphan hydrobromide

0280-1430

Bayer HealthCare LLC, Consumer Car Alka-Seltzer Plus Max Cough, Mucus and Congestion 2 BLISTER PACK in 1 CARTON (0280-1001-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

10 mg/1, 200 mg/1 Dextromethorphan hydrobromide and GUAIFENESIN

0280-1001

Bedrock Brands, LLC Maximum Strength Flu HBP 1 BLISTER PACK in 1 CARTON (76000-461-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK

500 mg/1, 15 mg/1, 2 mg/1 Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate

76000-461

Bedrock Brands, LLC Cough and Cold Relief HBP 3 BLISTER PACK in 1 CARTON (76000-411-08) > 8 TABLET in 1 BLISTER PACK

4 mg/1, 30 mg/1 Chlorpheniramine maleate and Dextromethorphan HBr

76000-411

Bedrock Brands, LLC High Blood Pressure Chest Congestion and Cough 1 BLISTER PACK in 1 CARTON (76000-533-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK

20 mg/1, 400 mg/1 Dextromethorphan HBr and Guiafenesin

76000-533

Best Choice Childrens Plus Cough and Runny Nose 118 mL in 1 BOTTLE, PLASTIC (63941-130-04)


ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

63941-130

Best Choice Childrens Plus Multi-Symptom Grape 118 mL in 1 BOTTLE, PLASTIC (63941-145-04)


ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

63941-145

DOH 690-292 May 2016 46 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBest Choice Childrens Plus Cough and Sore Throat 118 mL in 1 BOTTLE, PLASTIC

(63941-124-04)160 mg/5mL, 160 mg/5mL Acetaminophen,

DEXTROMETHORPHAN HYDROBROMIDE

63941-124

Best Choice Night Time Original 177 mL in 1 BOTTLE, PLASTIC (63941-112-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63941-112

Best Choice Night Time Cherry 177 mL in 1 BOTTLE, PLASTIC (63941-113-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63941-113

Best Choice Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (63941-213-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63941-213

Best Choice Day Time 177 mL in 1 BOTTLE, PLASTIC (63941-142-06)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


63941-142

Best Choice Night Time Cough 177 mL in 1 BOTTLE, PLASTIC (63941-072-06)


63941-072

Best Choice Tussin Sugar Free Cough 118 mL in 1 BOTTLE, PLASTIC (63941-100-04)

10 mg/5mL, 100 mg/5mL Dextromethorphan Hydrobromide, GUAIFENESIN,

63941-100

Best Choice Tussin DM 118 mL in 1 BOTTLE, PLASTIC (63941-018-04)


63941-018

Best Choice Tussin DM 237 mL in 1 BOTTLE, PLASTIC (63941-218-08)


63941-218

DOH 690-292 May 2016 47 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBest Choice (Valu Merchandisers ComChildrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (63941-



Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide

63941-297

Best Choice (Valu Merchandisers ComChildrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (63941-304-04) > 118 mL in 1 BOTTLE,PLASTIC



63941-304

Best Choice (Valu Merchandisers ComCold and Flu 177 mL in 1 BOTTLE, PLASTIC (63941-342-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63941-342


500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63941-342


500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63941-346


500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63941-346

Best Choice (Valu Merchandisers ComDaytime Cold and Flu 177 mL in 1 BOTTLE, PLASTIC (63941-466-06)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


63941-466

DOH 690-292 May 2016 48 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBest Choice (Valu Merchandisers ComDaytime Cold and Flu 296 mL in 1 BOTTLE, PLASTIC

(63941-466-10)325 mg/15mL, 10 mg/15mL, 5 mg/15mL


63941-466

Best Choice (Valu Merchandisers ComChildrens Cold and Cough 1 BOTTLE, PLASTIC in 1 BOX (63941-013-04) > 118 mL in 1 BOTTLE,PLASTIC

2 mg/10mL, 10 mg/10mL, 5 mg/10mL


63941-013

Best Choice (Valu Merchandisers ComCough Relief 1 BOTTLE, PLASTIC in 1 BOX (63941-309-04) > 118 mL in 1 BOTTLE,PLASTIC


Best Choice (Valu Merchandisers ComCough Relief 177 mL in 1 BOTTLE, PLASTIC (63941-345-06)

30 mg/30mL, 12.5 mg/30mL


63941-345

Best Choice (Valu Merchandisers ComTussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (63941-384-04) > 118 mL in 1 BOTTLE,PLASTIC


63941-384



63941-385



63941-385

Best Choice (Valu Merchandisers ComMucus Relief DM MAX 117 mL in 1 BOTTLE (63941-338-08) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL

Dextromethorphan HBr, Guaifenesin

63941-338

Best Choice (Valu Merchandisers ComTussin 1 BOTTLE, PLASTIC in 1 BOX (63941-382-04) > 118 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


63941-382

Best Choice (Valu Merchandisers ComChildrens Day Time Cold and Cough 1 BOTTLE in 1 BOX (63941-378-04) > 118 mL in 1 BOTTLE

2.5 mg/5mL, 5 mg/5mL Dextromethorphan HBr, Phenylephrine HCl

63941-378

DOH 690-292 May 2016 49 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBetter Living Brands, LLC Aspirin Free Cold Head Congestion Day Time 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin

21130-503

Better Living Brands, LLC Daytime Cold and Pain Relief 2 BLISTER PACK in 1 CARTON (21130-768-24) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


21130-768

Better Living Brands, LLC Cold, Flu and Sore Throat Relief 2 BLISTER PACK in 1 PACKAGE (21130-916-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


21130-916

Better Living Brands, LLC Severe Congestion and Cold 2 BLISTER PACK in 1 PACKAGE (21130-917-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


21130-917

Better Living Brands, LLC Pain Relief 2 BLISTER PACK in 1 CARTON (21130-560-08) > 12 TABLET in 1 BLISTER PACK


21130-560

Better Living Brands, LLC IMMEDIATE-RELEASE MUCUS RELIEF DM 3 BLISTER PACK in 1 CARTON (21130-533-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

20 mg/1, 400 mg/1 Dextromethorphan HBr, Guaifenesin

21130-533

Better Living Brands, LLC Mucus Relief DM 3 BLISTER PACK in 1 CARTON (21130-933-01) > 10 TABLET in 1 BLISTER PACK

400 mg/1, 20 mg/1 Guaifenesin, Dextromethorphan HBr

21130-933

Big Lots Stores, Inc. sound body cold and flu relief 355 mL in 1 BOTTLE (50594-335-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


50594-335

DOH 690-292 May 2016 50 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBig Lots Stores, Inc. sound body cold and flu relief 355 mL in 1 BOTTLE (50594-459-40) 650 mg/30mL, 30

mg/30mL, 12.5 mg/30mLAcetaminophen, Dextromethorphan HBr, Doxylamine succinate

50594-459

Big Lots Stores, Inc. Sound Body Cold and Flu Relief 12 BLISTER PACK in 1 CARTON (50594-014-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


50594-014

Bio-Pharm, Inc. Assured Childrens Cold and Cough 118 mL in 1 BOTTLE (59741-193-06) 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL

Brompheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride

59741-193

Bio-Pharm, Inc. Assured Day time Cold and Cough 118 mL in 1 BOTTLE (59741-201-06) 5 mg/5mL, 2.5 mg/5mL Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

59741-201

Bio-Pharm, Inc. Tussin DM 1 BOTTLE in 1 CARTON (59741-116-10) > 118 mL in 1 BOTTLE (59741-116-06)

100 mg/5mL, 10 mg/5mL Guaifenesin and Dextromethorphan Hydrobromide

59741-116

BJWC berkley and jensen tussin 1 BOTTLE in 1 CARTON (68391-001-34) > 237 mL in 1 BOTTLE


68391-001

BJWC berkley and jensen adult tussin dm 1 BOTTLE in 1 CARTON (68391-359-34) > 237 mL in 1 BOTTLE


68391-359

Blacksmith Brands, Inc. PediaCare Childrens Plus Cough and Runny Nose 1 BOTTLE in 1 BOX (52183-375-04) > 113 mL in 1 BOTTLE


Chloropheniramine Maleate and Dextromethorphan Hydrobromide and Acetaminophen

52183-375

Blacksmith Brands, Inc. PediaCare LongActing Cough 1 BOTTLE in 1 CARTON (52183-369-04) > 118 mL in 1 BOTTLE

7.5 mg/5mL Dextromethorphan HBr 52183-369

Blacksmith Brands, Inc. PediaCare Childrens Plus Cough and Sore Throat 1 BOTTLE in 1 BOX (52183-355-04) > 113 mL in 1 BOTTLE

5 mg/5mL, 160 mg/5mL Dextromethorphan Hydrobromide and Acetaminophen

52183-355

DOH 690-292 May 2016 51 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCBlacksmith Brands, Inc. PediaCare Childrens Plus Flu 1 BOTTLE in 1 BOX (52183-365-04)

> 113 mL in 1 BOTTLE5 mg/5mL, 160 mg/5mL, 1 mg/5mL

Chloropheniramine Maleate and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride and Ace

52183-365

Blacksmith Brands, Inc. PediaCare Childrens Plus Multisymptom Cold 1 BOTTLE in 1 BOX (52183-385-04) > 113 mL in 1 BOTTLE


Chloropheniramine Maleate and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride and Acet

52183-385

Blacksmith Brands, Inc. PediaCare Childrens Cough and Congestion 1 BOTTLE in 1 BOX (52183-395-04) > 118 mL in 1 BOTTLE


52183-395

Bryant Ranch Prepack MUCOSA DM 30 TABLET in 1 BOTTLE (63629-4458-1)

400 mg/1, 20 mg/1 GUAIFENESIN DEXTROMETHORPHAN

63629-4458

Bryant Ranch Prepack MUCOSA DM 20 TABLET in 1 BOTTLE (63629-4458-2)


63629-4458

BUREL PHARMACEUTICALS, INC RelCof DM 473 mL in 1 BOTTLE (35573-321-16) 4 mg/5mL, 15 mg/5mL, 7.5 mg/5mL

Brompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl

35573-321

BUREL PHARMACEUTICALS, INC Relhist DMX 60 TABLET in 1 BOTTLE (35573-322-60)

15 mg/1, 380 mg/1, 10 mg/1


35573-322

Capellon Pharmaceuticals, LLC Rescon DM 25 mL in 1 BOTTLE (64543-105-01) 2 mg/5mL, 10 mg/5mL, 30 mg/5mL

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride

64543-105C

DOH 690-292 May 2016 52 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCapellon Pharmaceuticals, LLC Rescon DM 118 mL in 1 BOTTLE (64543-105-04) 2 mg/5mL, 10 mg/5mL, 30

mg/5mLChlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride

64543-105

Capellon Pharmaceuticals, LLC Rescon DM 473 mL in 1 BOTTLE (64543-105-16) 2 mg/5mL, 10 mg/5mL, 30 mg/5mL

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride

64543-105

Capital Pharmaceutical CAPMIST 90 TABLET in 1 BOTTLE (29978-606-90)

30 mg/1, 400 mg/1, 30 mg/1

Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride

29978-606

Capital Pharmaceutical, LLC Aquanaz 100 TABLET in 1 BOTTLE (29978-587-01)

15 mg/1, 400 mg/1, 10 mg/1

Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride

29978-587

Capital Pharmaceutical, LLC Capmist DM 2 BLISTER PACK in 1 BOX (29978-601-30) > 15 TABLET in 1 BLISTERPACK

15 mg/1, 400 mg/1, 60 mg/1

Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride

29978-601

Capital Pharmaceutical, LLC Capmist DM 90 TABLET in 1 BOTTLE (29978-601-90)

15 mg/1, 400 mg/1, 60 mg/1

Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride

29978-601

Capital Pharmaceutical, LLC Capron DM 6 BOTTLE in 1 BOX (29978-127-15) > 15 mL in 1 BOTTLE

7.5 mg/5mL, 7.5 mg/5mL Dextromethorphan HBr and Pyrilamine Maleate

29978-127

DOH 690-292 May 2016 53 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCapital Pharmaceutical, LLC Capron DM 1 BOTTLE in 1 BOX (29978-127-16)

> 473 mL in 1 BOTTLE7.5 mg/5mL, 7.5 mg/5mL Dextromethorphan HBr and

Pyrilamine Maleate29978-127

Capricorn Pharma Inc. Expectorant plus Cough Relief 12 GRANULE in 1 CARTON (66007-204-01)

5 mg/1, 100 mg/1 Guaifenesin and Dextromethorphan

66007-204

Cardinal Health Cold Head Congestion 2 BLISTER PACK in 1 CARTON (49781-011-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl

49781-011

Cardinal Health leader cold head congestion 2 BLISTER PACK in 1 CARTON (37205-958-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


37205-958

Cardinal Health Leader Nite Time 8 BLISTER PACK in 1 CARTON (49781-074-16) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49781-074

Cardinal Health Leader Nite Time 12 BLISTER PACK in 1 CARTON (49781-074-24) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49781-074

Cardinal Health Leader Nite Time Cold Flu Relief 177 mL in 1 BOTTLE (37205-779-37) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


37205-779

Cardinal Health Leader Nite Time Cold Flu Relief 296 mL in 1 BOTTLE (37205-779-42) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


37205-779

DOH 690-292 May 2016 54 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCardinal Health Leader nite time 177 mL in 1 BOTTLE (37205-781-37) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mLacetaminophen,dextromethorphan HBr, doxylamine succinate

37205-781

Cardinal Health Leader nite time 296 mL in 1 BOTTLE (37205-781-42) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


37205-781

Cardinal Health leader nite time 296 mL in 1 BOTTLE (37205-851-42) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid

37205-851



37205-856



37205-586



37205-586



37205-586



37205-586



37205-587

DOH 690-292 May 2016 55 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCardinal Health leader nite time 177 mL in 1 BOTTLE (37205-587-37) 650 mg/30mL, 30


37205-587



37205-587



37205-587

Cardinal Health Leader Nite Time 1 BLISTER PACK in 1 CARTON (37205-707-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37205-707


325 mg/1, 15 mg/1, 6.25 mg/1


37205-707


325 mg/1, 15 mg/1, 6.25 mg/1


37205-707

Cardinal Health Leader Severe Sinus Congestion 10 BLISTER PACK in 1 CARTON (49781-056-20) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


49781-056

DOH 690-292 May 2016 56 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCardinal Health leader nite time 237 mL in 1 BOTTLE (49781-054-08) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


49781-054

Cardinal Health Leader Day Time 6 BLISTER PACK in 1 CARTON (49781-055-12) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49781-055

Cardinal Health Leader Mucus Relief 2 BLISTER PACK in 1 CARTON (49781-036-20) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49781-036


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49781-038

Cardinal Health Leader Day Time 237 mL in 1 BOTTLE (49781-052-08) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


49781-052

Cardinal Health Leader Severe Cold and Flu 12 BLISTER PACK in 1 CARTON (49781-067-24) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49781-067


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49781-125

DOH 690-292 May 2016 57 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCardinal Health leader cold head congestion 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37205-828

Cardinal Health Leader Cold Head Congestion 2 BLISTER PACK in 1 CARTON (37205-959-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


37205-959

Cardinal Health Leader Day Time 6 BLISTER PACK in 1 CARTON (37205-705-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37205-705



37205-705



37205-705

Cardinal Health leader day time 177 mL in 1 BOTTLE (37205-719-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


37205-719



37205-719



37205-719

DOH 690-292 May 2016 58 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCARDINAL HEALTH Cold Head Congestion 1 BLISTER PACK in 1 BOX (37205-

756-62) > 24 TABLET, FILM COATEDin 1 BLISTER PACK


37205-756

Cardinal Health leader flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (37205-678-91)

650 mg/1, 20 mg/1, 10 mg/1


37205-678

Cardinal Health leader flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (49781-126-06)

650 mg/1, 20 mg/1, 10 mg/1


49781-126

Cardinal Health Leader Childrens Cold and Cough 1 BOTTLE in 1 CARTON (37205-969-26) > 118 mL in 1 BOTTLE



37205-969

Cardinal Health leader cough dm 1 BOTTLE in 1 CARTON (37205-697-21) > 89 mL in 1 BOTTLE






Cardinal Health leader nite time cough 355 mL in 1 BOTTLE (37205-695-40) 30 mg/30mL, 12.5 mg/30mL


37205-695

Cardinal Health leader tussin dm 1 BOTTLE in 1 CARTON (37205-970-26) > 118 mL in 1 BOTTLE


37205-970

Cardinal Health leader tussin dm 1 BOTTLE in 1 CARTON (37205-970-34) > 237 mL in 1 BOTTLE


37205-970

Cardinal Health Leader Childrens Mucus Relief Cough 1 BOTTLE in 1 CARTON (37205-993-26) > 118 mL in 1 BOTTLE


37205-993

DOH 690-292 May 2016 59 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCardinal Health Leader Adult Tussin DM 1 BOTTLE in 1 CARTON (37205-712-

26) > 118 mL in 1 BOTTLE20 mg/10mL, 200 mg/10mL Dextromethorphan HBr,

Guaifenesin37205-712

Cardinal Health leader tussin 1 BOTTLE in 1 CARTON (37205-686-26) > 118 mL in 1 BOTTLE


37205-686

Cardinal Health Leader Chest Congestion Relief Plus DMDM 1 TABLET in 1 CARTON (37205-538-01)


37205-538

Cardinal Health Leader Chest Congestion Relief Plus DMDM 50 TABLET in 1 BOTTLE, PLASTIC (37205-538-71)


37205-538

Cardinal Health LEADER iNTENSE COUGH RELIEVER 1 BOTTLE, PLASTIC in 1 CARTON (37205-610-01) > 120 mL in 1 BOTTLE, PLASTIC (37205-610-26)

20 mg/5mL, 300 mg/5mL Dextromethorphan Hydrobromide / Guaifenesin

37205-610

Cardinal Health Leader tussin dm max 1 BOTTLE in 1 CARTON (37205-629-26) > 118 mL in 1 BOTTLE


37205-629

Cardinal Health Leader tussin dm max 1 BOTTLE in 1 CARTON (37205-629-34) > 237 mL in 1 BOTTLE


37205-629

Cardinal Health Leader TabTussin DM 2 TABLET in 1 CARTON (37205-675-01)


37205-675

Cardinal Health Leader TabTussin DM 12 TABLET in 1 BLISTER PACK (37205-675-62)


37205-675

Cardinal Health Leader Childrens Mucus Relief 1 BOTTLE in 1 CARTON (49781-053-04) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


49781-053

Cardinal Health leader tussin cf max 1 BOTTLE in 1 CARTON (37205-696-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


37205-696

Cardinal Health leader tussin cf 1 BOTTLE in 1 CARTON (37205-709-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


37205-709

DOH 690-292 May 2016 60 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCardinal Health leader tussin cf 1 BOTTLE in 1 CARTON (37205-709-



37205-709

Cardinal Health Leader Day time Cough and Cold 1 BOTTLE in 1 CARTON (37205-994-26) > 118 mL in 1 BOTTLE


37205-994

Cardinal Health Guaifenesin and Dextromethorphan 5 CUP, UNIT-DOSE in 1 BAG (55154-9420-5) > 10 mL in 1 CUP, UNIT-DOSE

200 mg/10mL, 20 mg/10mL Guaifenesin and Dextromethorphan

55154-9420

Cardinal Health Guaifenesin and Dextromethorphan 5 CUP, UNIT-DOSE in 1 BAG (55154-9446-5) > 5 mL in 1 CUP, UNIT-DOSE

100 mg/5mL, 10 mg/5mL Guaifenesin and Dextromethorphan

55154-9446

Care One (American Sales Company) Childrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (41520-297-04) > 118 mL in 1 BOTTLE,PLASTIC



41520-297

Care One (American Sales Company) Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (41520-704-04) > 118 mL in 1 BOTTLE,PLASTIC



41520-704

Care One (American Sales Company) Multi Symptom Nitetime 24 BLISTER PACK in 1 CARTON (41520-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41520-071

Care One (American Sales Company) Nitetime 2 BLISTER PACK in 1 CARTON (41520-480-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41520-480

DOH 690-292 May 2016 61 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCare One (American Sales Company) Nitetime 2 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


41520-480

Care One (American Sales Company) Nitetime Cold Flu Relief 24 BLISTER PACK in 1 CARTON (41520-445-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41520-445

Care One (American Sales Company) Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (41520-036-06)



41520-036

Care One (American Sales Company) Childrens Cold and Cough 1 BOTTLE, PLASTIC in 1 BOX (41520-613-04) > 118 mL in 1 BOTTLE,PLASTIC

2 mg/10mL, 10 mg/10mL, 5 mg/10mL


41520-613

Care One (American Sales Company) Childrens Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (41520-454-04) > 118 mL in 1 BOTTLE,PLASTIC


Care One (American Sales Company) Tussin Cough Long Acting 1 BOTTLE, PLASTIC in 1 BOX (41520-383-04) > 118 mL in 1 BOTTLE,PLASTIC


Care One (American Sales Company) Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (41520-308-04) > 118 mL in 1 BOTTLE,PLASTIC


Care One (American Sales Company) Tussin DM Cough and Chest Congestion 1 BOTTLE, PLASTIC in 1 BOX (41520-385-04) > 118 mL in 1 BOTTLE,PLASTIC


41520-385

DOH 690-292 May 2016 62 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCare One (American Sales Company) Mucus Relief 177 mL in 1 BOTTLE, PLASTIC

(41520-037-06)20 mg/20mL, 400 mg/20mL, 10 mg/20mL

dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

41520-037

Care One (American Sales Company) Triacting Day Time Cold and Cough 1 BOTTLE, PLASTIC in 1 BOX (41520-378-04) > 118 mL in 1 BOTTLE,PLASTIC


41520-378

Caribe Natural, LLC BRONCO SILEN-DM 118 mL in 1 BOTTLE, PLASTIC (59561-202-04)


59561-202

Chain Drug Consortium Mucus Relief 50 TABLET in 1 BOX (68016-179-50) 20 mg/1, 400 mg/1 Dextromehtorphan HBr / Guaifenesin

68016-179

Chain Drug Consortium LLC Adult Long Lasting-Cough Relief 1 BOTTLE in 1 CARTON (68016-026-20) > 20 CAPSULE in 1 BOTTLE

15 mg/1 Dextromethorphan HBr,USP 68016-026

Chain Drug Consortium, LCC Daytime Cold and Flu Relief Plus 2 CARTON in 1 BLISTER PACK (68016-719-20) > 10 CAPSULE in 1 CARTON

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride

68016-719

Chain Drug Consortium, LLC Childrens Plus Cough and Runny Nose 118 mL in 1 BOTTLE, PLASTIC (68016-130-04)



68016-130

Chain Drug Consortium, LLC COLD and FLU Nighttime Relief 237 mL in 1 BOTTLE (68016-709-08) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68016-709



68016-710

DOH 690-292 May 2016 63 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Consortium, LLC COLD and FLU Nighttime Relief 355 mL in 1 BOTTLE (68016-710-12) 650 mg/30mL, 30

mg/30mL, 12.5 mg/30mLAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr

68016-710

Chain Drug Consortium, LLC Night Time 120 mL in 1 BOTTLE (68016-135-00) 325 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


68016-135

Chain Drug Consortium, LLC Night Time 177 mL in 1 BOTTLE, PLASTIC (68016-113-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


68016-113

Chain Drug Consortium, LLC Night-Time Original 236 mL in 1 BOTTLE (68016-144-00) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68016-144

Chain Drug Consortium, LLC Night-Time Original 354 mL in 1 BOTTLE (68016-144-01) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68016-144

Chain Drug Consortium, LLC Night-Time Cherry 236 mL in 1 BOTTLE (68016-146-00) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68016-146

Chain Drug Consortium, LLC Night-Time Cherry 354 mL in 1 BOTTLE (68016-146-01) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68016-146

DOH 690-292 May 2016 64 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Consortium, LLC Multi symptom Nighttime 2 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


68016-202

Chain Drug Consortium, LLC Multi symptom Nighttime 2 BLISTER PACK in 1 CARTON (68016-202-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


68016-202

Chain Drug Consortium, LLC Nighttime Cold and flu Relief 8 CARTON in 1 BLISTER PACK (68016-599-16) > 2 CAPSULE, LIQUID FILLED in 1 CARTON

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate,

68016-599

Chain Drug Consortium, LLC Nighttime Cold and flu Relief 12 CARTON in 1 BLISTER PACK (68016-599-24) > 2 CAPSULE, LIQUID FILLED in 1 CARTON

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate,

68016-599



68016-707

Chain Drug Consortium, LLC COLD and FLU Day Time Multi-Symptom Relief 237 mL in 1 BOTTLE (68016-706-08) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68016-706

Chain Drug Consortium, LLC COLD and FLU Day Time Multi-Symptom Relief 354 mL in 1 BOTTLE (68016-706-12) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68016-706

Chain Drug Consortium, LLC Day Time Cold non drowsy cold and Flu Relief 2 BLISTER PACK in 1 CARTON (68016-470-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


68016-470

DOH 690-292 May 2016 65 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Consortium, LLC Daytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine

68016-598

Chain Drug Consortium, LLC Daytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (68016-598-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine

68016-598

Chain Drug Consortium, LLC Daytime 2 BLISTER PACK in 1 CARTON (68016-199-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


68016-199

Chain Drug Consortium, LLC Daytime 2 BLISTER PACK in 1 CARTON (68016-199-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


68016-199

Chain Drug Consortium, LLC Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC (68016-155-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68016-155

Chain Drug Consortium, LLC Day Time 177 mL in 1 BOTTLE, PLASTIC (68016-142-06)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68016-142

Chain Drug Consortium, LLC Day Time 296 mL in 1 BOTTLE, PLASTIC (68016-142-01)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68016-142

DOH 690-292 May 2016 66 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Consortium, LLC Daytime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC

(68016-727-02)325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68016-727

Chain Drug Consortium, LLC Daytime Cold and Flu 236 mL in 1 BOTTLE, PLASTIC (68016-727-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68016-727

Chain Drug Consortium, LLC Childrens Cold, Cough and Sore Throat 118 mL in 1 BOTTLE (68016-224-00) 325 mg/10mL, 200 mg/10mL, 10 mg/10mL, 5 mg/10mL

ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL

68016-224

Chain Drug Consortium, LLC Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (68016-156-04) > 118 mL in 1 BOTTLE,PLASTIC


Chain Drug Consortium, LLC Tussin Long Acting Cough 1 BOTTLE, PLASTIC in 1 BOX (68016-098-04) > 118 mL in 1 BOTTLE,PLASTIC


Chain Drug Consortium, LLC Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (68016-072-01)

15 mg/15mL, 6.25 mg/15mL

DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

68016-072

Chain Drug Consortium, LLC COUGH Nighttime Cough Relief 236 mL in 1 BOTTLE (68016-708-08) 30 mg/30mL, 12.5 mg/30mL


68016-708

Chain Drug Consortium, LLC Tussin DM 237 mL in 1 BOTTLE (68016-855-56) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

68016-855

Chain Drug Consortium, LLC Tussin DM 354 mL in 1 BOTTLE (68016-855-57) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

68016-855

DOH 690-292 May 2016 67 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Consortium, LLC DM MAX 177 mL in 1 BOTTLE (68016-222-00) 20 mg/20mL, 400 mg/20mL DEXTROMETHORPHAN

HYDROBROMIDE, GUAIFENESIN

68016-222

Chain Drug Consortium, LLC Childrens Mucus Relief COUGH 118 mL in 1 BOTTLE (68016-158-04) 5 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

68016-158

Chain Drug Consortium, LLC Tussin DM 118 mL in 1 BOTTLE, PLASTIC (68016-018-04)


68016-018

Chain Drug Consortium, LLC Tussin DM 237 mL in 1 BOTTLE, PLASTIC (68016-018-08)


68016-018

Chain Drug Consortium, LLC Tussin Sugar Free 118 mL in 1 BOTTLE, PLASTIC (68016-100-04)


68016-100

Chain Drug Consortium, LLC Tussin CF 118 mL in 1 BOTTLE, PLASTIC (68016-126-04)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


68016-126

Chain Drug Consortium, LLC Tussin CF 237 mL in 1 BOTTLE, PLASTIC (68016-126-08)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


68016-126

Chain Drug Consortium, LLC Severe Congestion and Cough MAX 177 mL in 1 BOTTLE (68016-221-00) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


68016-221

DOH 690-292 May 2016 68 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Consortium, LLC Childrens Multi-Symptom Cold 118 mL in 1 BOTTLE (68016-134-00) 100 mg/5mL, 5 mg/5mL,

2.5 mg/5mLGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

68016-134

Chain Drug Consortium,LLC Nighttime Cold and Flu Relief Plus 2 CARTON in 1 BLISTER PACK (68016-720-20) > 10 CAPSULE in 1 CARTON

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride

68016-720

Chain Drug Marketing Association Cold Head Congestion Nighttime 2 BLISTER PACK in 1 CARTON (63868-074-24) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


63868-074

Chain Drug Marketing Association Cold Multi Symptom Nighttime 2 BLISTER PACK in 1 CARTON (63868-072-24) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


63868-072

Chain Drug Marketing Association Severe Cold Head Congestion 2 BLISTER PACK in 1 CARTON (63868-075-24) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63868-075

DOH 690-292 May 2016 69 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Marketing Association Mucus Relief Severe Cold 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63868-716

Chain Drug Marketing Association Mucus Relief Cold Flu and Sore Throat 2 BLISTER PACK in 1 CARTON (63868-719-20) > 10 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63868-719

Chain Drug Marketing Association Pressure Pain Cold PE 2 BLISTER PACK in 1 CARTON (63868-721-24) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


63868-721

Chain Drug Marketing Association Severe Cold Multi Symptom 2 BLISTER PACK in 1 CARTON (63868-073-24) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63868-073

DOH 690-292 May 2016 70 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCChain Drug Marketing Association Severe Cold and Flu 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63868-003

Chain Drug Marketing Association Cold and Cough 2 BLISTER PACK in 1 CARTON (63868-004-20) > 10 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


63868-004

Chain Drug Marketing Association Quality Choice Daytime Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (63868-763-06)

650 mg/1, 20 mg/1, 10 mg/1


63868-763

Chain Drug Marketing Association Pressure Pain Cough PE 2 BLISTER PACK in 1 CARTON (63868-720-24) > 12 TABLET, COATED in 1 BLISTER PACK


63868-720

Chain Drug Marketing Association Quality Choice Mucus Relief DM 1 BOTTLE in 1 CARTON (63868-753-50) > 50 TABLET in 1 BOTTLE


63868-753

CHAIN DRUG MARKETING ASSOCIATIFlu HBP 2 BLISTER PACK in 1 CARTON (63868-142-20) > 10 TABLET, FILM COATED in 1 BLISTER PACK

500 mg/1, 2 mg/1, 15 mg/1 Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr

63868-142

CHAIN DRUG MARKETING ASSOCIATICough and Cold HBP 2 BLISTER PACK in 1 CARTON (63868-145-01) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


63868-145

DOH 690-292 May 2016 71 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCHAIN DRUG MARKETING ASSOCIATICough and Cold HBP 3 BLISTER PACK in 1 CARTON

(63868-145-16) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


63868-145

Cintex Services, LLC BPM-DM-PHEN 473 mL in 1 BOTTLE, PLASTIC (24470-914-16)



24470-914

Combe Incorporated Cepacol Sore Throat Plus Cough 2 BLISTER PACK in 1 CARTON (11509-0020-1) > 9 LOZENGE in 1 BLISTER PACK

7.5 mg/1, 5 mg/1 benzocaine and dextromethorphan hydrobromide

11509-0020

Costco Wholesale Company kirkland signature cold 3 BOTTLE in 1 CARTON (63981-903-40) > 118 mL in 1 BOTTLE



63981-903

COSTCO WHOLESALE CORPORATION Cold Multi-Symptom 4 BLISTER PACK in 1 CARTON (63981-591-22) > 12 TABLET in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


63981-591

COSTCO WHOLESALE CORPORATION Nighttime Cold Multi Symptom 1 BLISTER PACK in 1 CARTON (63981-591-46) > 96 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


63981-591

COSTCO WHOLESALE CORPORATION Multi-Symptom Daytime Cold 1 BLISTER PACK in 1 CARTON (63981-560-46) > 96 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


63981-560

DOH 690-292 May 2016 72 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCreekwood Pharmaceuticals Inc. Dimetane 118 mL in 1 BOTTLE (15310-106-04) 2 mg/5mL, 30 mg/5mL, 10

mg/5mLBrompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

15310-106

CVS Childrens Plus Cough and Runny Nose 118 mL in 1 BOTTLE, PLASTIC (59779-242-44)



59779-242

CVS Childrens Plus Flu 118 mL in 1 BOTTLE, PLASTIC (59779-144-44)



59779-144

CVS Night Time Cough and Sore Throat Cool Blast 237 mL in 1 BOTTLE, PLASTIC (59779-666-34)

1000 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

Tylenol Cough and Sore Throat 59779-666

CVS Night Time Cherry 177 mL in 1 BOTTLE, PLASTIC (59779-140-36)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

Doxylamine Succinate, Acetaminophen, Dextromethorphan Hydrobromide

59779-140

CVS Cough Relief Grape 118 mL in 1 BOTTLE, PLASTIC (59779-159-26)

15 mg/5mL Delsym Grape 59779-159

CVS Tussin Cough Long Acting 237 mL in 1 BOTTLE, PLASTIC (59779-300-34)


59779-300

DOH 690-292 May 2016 73 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC

(59779-040-21)15 mg/15mL, 135 mg/5mL DEXTROMETHORPHAN

HYDROBROMIDE, DOXYLAMINE SUCCINATE

59779-040

CVS Tussin Sugar Free Cough 237 mL in 1 BOTTLE, PLASTIC (59779-578-34)


59779-578

CVS Pharmacy Multi Symptom Cold Relief 1 BOTTLE in 1 CARTON (59779-903-26) > 118 mL in 1 BOTTLE



59779-903

CVS Pharmacy Childrens Flu Relief 1 BOTTLE, PLASTIC in 1 BOX (59779-933-04) > 118 mL in 1 BOTTLE,PLASTIC


Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI

59779-933

CVS Pharmacy cough and sore throat 1 BOTTLE in 1 CARTON (59779-196-26) > 118 mL in 1 BOTTLE


59779-196

CVS Pharmacy Flu HBP 2 BLISTER PACK in 1 CARTON (59779-461-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK


59779-461

CVS Pharmacy Nighttime 1 BLISTER PACK in 1 CARTON (59779-977-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59779-977


325 mg/1, 15 mg/1, 6.25 mg/1


59779-977

DOH 690-292 May 2016 74 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Nighttime 2 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


59779-977


325 mg/1, 15 mg/1, 6.25 mg/1


59779-977


325 mg/1, 15 mg/1, 6.25 mg/1


59779-977


325 mg/1, 15 mg/1, 6.25 mg/1


59779-977


325 mg/1, 15 mg/1, 6.25 mg/1


59779-977


325 mg/1, 15 mg/1, 6.25 mg/1


59779-977

CVS Pharmacy NIGHTTIME 177 mL in 1 BOTTLE (59779-908-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

acetaminophen, dextromethorphan HBr, doxylamine succinate

59779-908

DOH 690-292 May 2016 75 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy NIGHTTIME 295 mL in 1 BOTTLE (59779-908-38) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mLacetaminophen, dextromethorphan HBr, doxylamine succinate

59779-908



59779-908



59779-908

CVS Pharmacy nighttime cold flu relief 12 BLISTER PACK in 1 CARTON (59779-803-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59779-803


325 mg/1, 15 mg/1, 6.25 mg/1


59779-803


325 mg/1, 15 mg/1, 6.25 mg/1


59779-803

CVS Pharmacy Nighttime Cold Flu Relief 2 BLISTER PACK in 1 CARTON (59779-465-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59779-465

CVS Pharmacy Nighttime Cold Flu Relief 3 BLISTER PACK in 1 CARTON (59779-465-36) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59779-465

DOH 690-292 May 2016 76 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Nighttime Cold Flu Relief 4 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


59779-465

CVS Pharmacy nighttime 177 mL in 1 BOTTLE (59779-459-30) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


59779-459



59779-459



59779-459

CVS Pharmacy nighttime 2 BOTTLE in 1 PACKAGE (59779-459-50) > 355 mL in 1 BOTTLE (59779-459-40)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


59779-459

CVS Pharmacy Night Time Cold and Flu Relief 16 BLISTER PACK in 1 CARTON (59779-671-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59779-671

CVS Pharmacy cold and cough nighttime 237 mL in 1 BOTTLE (59779-293-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


59779-293

CVS Pharmacy Nighttime Cold and Flu Relief 177 mL in 1 BOTTLE (59779-335-30) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


59779-335



59779-335

DOH 690-292 May 2016 77 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Nighttime Cold and Flu Relief 295 mL in 1 BOTTLE (59779-335-38) 650 mg/30mL, 30


59779-335



59779-335

CVS Pharmacy Nighttime Cold and Flu Relief 2 BOTTLE in 1 PACKAGE (59779-335-50) > 355 mL in 1 BOTTLE

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


59779-335

CVS Pharmacy CVS Nighttime Cold/Flu Relief 177 mL in 1 BOTTLE (59779-041-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


59779-041



59779-041



59779-041



59779-041

CVS Pharmacy Cold Relief 237 mL in 1 BOTTLE, PLASTIC (59779-739-08)



59779-739

DOH 690-292 May 2016 78 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Severe Nighttime 237 mL in 1 BOTTLE (59779-763-34) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


59779-763

CVS Pharmacy Severe Nighttime 355 mL in 1 BOTTLE (59779-763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


59779-763

CVS Pharmacy Cold Relief 237 mL in 1 BOTTLE, PLASTIC (59779-941-08)


Dextromethorphan HBr, Guaifenesin

59779-941

CVS Pharmacy Severe Daytime 237 mL in 1 BOTTLE (59779-603-34) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


59779-603

CVS Pharmacy Severe Daytime 355 mL in 1 BOTTLE (59779-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


59779-603

CVS Pharmacy Severe Daytime 12 BLISTER PACK in 1 CARTON (59779-631-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


59779-631

CVS Pharmacy Daytime 177 mL in 1 BOTTLE (59779-656-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL

acetaminophen, dextromethorphan hbr, phenylephrine hcl

59779-656



59779-656

DOH 690-292 May 2016 79 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Daytime 295 mL in 1 BOTTLE (59779-656-38) 325 mg/15mL, 10

mg/15mL, 5 mg/15mLacetaminophen, dextromethorphan hbr, phenylephrine hcl

59779-656



59779-656

CVS Pharmacy Cold Relief 2 BLISTER PACK in 1 CARTON (59779-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


59779-402

CVS Pharmacy Daytime Cold Flu Relief 2 BLISTER PACK in 1 CARTON (59779-472-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


59779-472



59779-472



59779-472



59779-472

DOH 690-292 May 2016 80 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Flu and Severe Cold and Cough 6 POWDER, FOR SOLUTION in 1

CARTON (59779-096-91)650 mg/1, 20 mg/1, 10 mg/1


59779-096

CVS Pharmacy daytime 1 BLISTER PACK in 1 CARTON (59779-215-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


59779-215



59779-215



59779-215

CVS Pharmacy CVS Pharmacy Daytime Severe Cough and Cold 6 GRANULE, FOR SOLUTION in 1 BOX (59779-220-06)

650 mg/1, 20 mg/1, 10 mg/1


59779-220

CVS Pharmacy Daytime 16 BLISTER PACK in 1 CARTON (59779-868-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


59779-868



59779-868



59779-868

DOH 690-292 May 2016 81 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Daytime 48 BLISTER PACK in 1 CARTON



59779-868

CVS Pharmacy Cold Relief 2 BLISTER PACK in 1 CARTON (59779-870-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK


59779-870

CVS Pharmacy Flu and Severe Cold 245 mL in 1 BOTTLE, PLASTIC (59779-926-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL


59779-926



59779-994



59779-994



59779-994



59779-994



59779-994



59779-994

DOH 690-292 May 2016 82 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy daytime 2 BLISTER PACK in 1 CARTON



59779-994

CVS Pharmacy Cold and Cough 1 BOTTLE in 1 CARTON (59779-363-26) > 118 mL in 1 BOTTLE



59779-363

CVS Pharmacy Cough and Cold 2 BLISTER PACK in 1 CARTON (59779-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


59779-411

CVS Pharmacy cough dm 1 BOTTLE in 1 CARTON (59779-924-21) > 89 mL in 1 BOTTLE


CVS Pharmacy cough dm 1 BOTTLE in 1 CARTON (59779-924-28) > 148 mL in 1 BOTTLE


CVS Pharmacy Cough DM 1 BOTTLE in 1 CARTON (59779-958-21) > 89 mL in 1 BOTTLE








CVS Pharmacy tussin 1 BOTTLE in 1 CARTON (59779-433-26) > 118 mL in 1 BOTTLE


59779-433

CVS Pharmacy tussin 1 BOTTLE in 1 CARTON (59779-433-34) > 237 mL in 1 BOTTLE


59779-433



CVS Pharmacy Tussin DM 1 BOTTLE in 1 BOX (59779-145-04) > 118 mL in 1 BOTTLE

30 mg/10mL, 12.5 mg/10mL


59779-145

DOH 690-292 May 2016 83 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Tussin DM 1 BOTTLE in 1 BOX (59779-145-08)

> 237 mL in 1 BOTTLE30 mg/10mL, 12.5 mg/10mL


59779-145

CVS Pharmacy nighttime cough 295 mL in 1 BOTTLE (59779-668-38) 30 mg/30mL, 12.5 mg/30mL


59779-668

CVS Pharmacy nighttime cough 355 mL in 1 BOTTLE (59779-668-40) 30 mg/30mL, 12.5 mg/30mL


59779-668

CVS Pharmacy Tussin DMMaximum Strength 1 BOTTLE in 1 CARTON (59779-967-03) > 118 mL in 1 BOTTLE


59779-967

CVS Pharmacy Tussin DMMaximum Strength 1 BOTTLE in 1 CARTON (59779-967-04) > 237 mL in 1 BOTTLE


59779-967

CVS Pharmacy tussin dm 1 BOTTLE in 1 CARTON (59779-919-26) > 118 mL in 1 BOTTLE


59779-919

CVS Pharmacy tussin dm 1 BOTTLE in 1 CARTON (59779-919-34) > 237 mL in 1 BOTTLE


59779-919

CVS Pharmacy chest congestion 1 BOTTLE in 1 CARTON (59779-419-26) > 118 mL in 1 BOTTLE


59779-419

CVS Pharmacy Tussin DM 1 BOTTLE in 1 CARTON (59779-557-26) > 118 mL in 1 BOTTLE


59779-557



59779-557



59779-359



59779-359



59779-359

DOH 690-292 May 2016 84 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy Tussin CF 1 BOTTLE in 1 BOX (59779-047-04)

> 118 mL in 1 BOTTLE20 mg/10mL, 400 mg/10mL, 10 mg/10mL


59779-047

CVS Pharmacy Tussin CF 1 BOTTLE in 1 CARTON (59779-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


59779-516


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


59779-516


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


59779-516

CVS Pharmacy Tussin CF 1 BOTTLE, PLASTIC in 1 BOX (59779-412-04) > 118 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


59779-412

CVS Pharmacy Tussin CF 1 BOTTLE, PLASTIC in 1 BOX (59779-412-08) > 237 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


59779-412

CVS Pharmacy Severe Congestion and Cough 3 BLISTER PACK in 1 CARTON (59779-648-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

200 mg/1, 5 mg/1, 10 mg/1 Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

59779-648

CVS Pharmacy, Inc. CVS - Childrens Mucus Relief Cough, Cold and Sore Throat



69842-006

CVS Pharmacy, Inc. CVS Sore Throat Mixed Berry Flavor 18 LOZENGE in 1 CARTON (59779-649-18)

7.5 mg/1, 5 mg/1 BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE

59779-649

DOH 690-292 May 2016 85 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCCVS Pharmacy, Inc. Childrens Cough and Chest Congestion DM 1 BOTTLE in 1 CARTON (59779-907-



CVS Pharmacy, Inc. Childrens Cough and Cold CF 1 BOTTLE in 1 CARTON (59779-984-24) > 118 mL in 1 BOTTLE

10 mg/10mL, 100 mg/10mL, 5 mg/10mL


59779-984

CVS Pharmacy, Inc. CVS Pharmacy Cough Relief Honey Lemon Flavor 16 LOZENGE in 1 CARTON (59779-064-16)

5 mg/1, 5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL

59779-064

CVS Pharmacy, Inc. Childrens Daytime Cold and Cough 1 BOTTLE in 1 CARTON (59779-890-24) > 118 mL in 1 BOTTLE

5 mg/5mL, 2.5 mg/5mL Dextromethorphan HBr, Phenylephrine hydrochloride

59779-890

Cypress Pharmaceutical, Inc. De-Chlor 473 mL in 1 BOTTLE (60258-521-16) 15 mg/5mL, 10 mg/5mL, 2 mg/5mL

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorpheniramine Maleate

60258-521

Dannso Corp./d.b.a. Essential ProducBroncomar 1 BOTTLE in 1 CARTON (70242-102-06) > 177 mL in 1 BOTTLE

250 mg/10mL, 13.33 mg/10mL, 200 mg/10mL, 5 mg/10mL

Acetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

70242-102



70242-101



70242-103

davAgen Pharmaceutical, LLC Tussin DM 1 BOTTLE, PLASTIC in 1 CARTON (76140-106-08) > 236 mL in 1 BOTTLE, PLASTIC


76140-106

davAgen Pharmaceutical, LLC Tussin CF 1 BOTTLE, PLASTIC in 1 CARTON (76140-105-08) > 236 mL in 1 BOTTLE, PLASTIC

10 mg/5mL, 100 mg/5mL, 5 mg/5mL

Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride

76140-105

D

DOH 690-292 May 2016 86 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDeliz Pharmaceutical Corp DELTUSS DMX Cough Suppressant Nasal Decongestant

Antihistamine GRAPE Flavor1 BOTTLE in 1 CARTON (58238-225-04) > 118 mL in 1 BOTTLE


DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

58238-225

Deliz Pharmaceutical Corp TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor

1 BOTTLE in 1 PACKAGE (58238-229-02) > 60 mL in 1 BOTTLE


58238-229

Deliz Pharmaceutical Corp TRISPEC DMX Cough Suppressant Expectorant Peach Flavor



58238-227

Deliz Pharmaceutical Corp TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor


10 mg/5mL, 187 mg/5mL, 30 mg/5mL

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

58238-230

Deliz Pharmaceutical Corp TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor


10 mg/5mL, 187 mg/5mL, 30 mg/5mL


58238-228

DeMoulas Market Basket NIGHT-TIME 354 mL in 1 BOTTLE (53942-501-28) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


53942-501

DOH 690-292 May 2016 87 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDeMoulas Market Basket NIGHT-TIME 354 mL in 1 BOTTLE (53942-502-28) 650 mg/30mL, 30

mg/30mL, 12.5 mg/30mLACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

53942-502

DeMoulas Market Basket Cold, Flu and Sore Throat 177 mL in 1 BOTTLE (53942-516-25) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

53942-516

DeMoulas Market Basket DAY-TIME 354 mL in 1 BOTTLE (53942-506-28) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


53942-506

DeMoulas Market Basket Tussin DM 237 mL in 1 BOTTLE (53942-503-26) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

53942-503

DeMoulas Market Basket Tussin CF Multi-Symptom Cold 237 mL in 1 BOTTLE (53942-504-26) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


53942-504

Discount Drug Mart Original Night-Time 354 mL in 1 BOTTLE (53943-501-28) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


53943-501

DOH 690-292 May 2016 88 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDiscount Drug Mart Night-Time 354 mL in 1 BOTTLE (53943-502-28) 650 mg/30mL, 30


53943-502

Discount Drug Mart Day-Time 354 mL in 1 BOTTLE (53943-506-28) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL

53943-506

Discount Drug Mart Night-Time 354 mL in 1 BOTTLE (53943-508-28) 30 mg/30mL, 12.5 mg/30mL

DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

53943-508

Discount Drug Mart MAXIUM STRENGTH DM MAX 117 mL in 1 BOTTLE (53943-518-25) 20 mg/20mL, 400 mg/20mL DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

53943-518

Discount Drug Mart Tussin DM 237 mL in 1 PACKAGE (53943-503-26)


53943-503

DISCOUNT DRUG MART Tussin Peak Cold sugar-free COUGH PLUS CHEST CONGESTION DM



53943-023

Discount Drug Mart Tussin CF 237 mL in 1 BOTTLE (53943-504-26) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


53943-504

Discount Drug Mart MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX



53943-517

DOH 690-292 May 2016 89 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDispensing Solutions, Inc. good sense tussin dm 118 mL in 1 BOTTLE (68258-8905-4) 10 mg/5mL, 100 mg/5mL Dextromethorphan HBr,


DLC Laboratories, Inc. Bactimicina Childrens Cough and Cold 1 BOTTLE in 1 BOX (24286-1551-4) > 118 mL in 1 BOTTLE

1 mg/5mL, 7.5 mg/5mL CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

24286-1551

DLC Laboratories, Inc. BACTIMICINA COUGH AND COLD 1 BOTTLE in 1 BOX (24286-1546-4) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


24286-1546

Dolgencorp Inc DG Health cold multi symptom 2 BLISTER PACK in 1 CARTON (55910-014-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55910-014

Dolgencorp Inc rexall night time cold and flu 237 mL in 1 BOTTLE (55910-872-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55910-872

Dolgencorp Inc rexall night time cold and flu 296 mL in 1 BOTTLE (55910-872-38) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55910-872

Dolgencorp Inc DG Health cold and flu relief 296 mL in 1 BOTTLE (55910-041-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55910-041

DOH 690-292 May 2016 90 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp Inc DG Health Cold and Flu Relief 10 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


55910-300

Dolgencorp Inc DG Health Cold and Flu Relief 6 BLISTER PACK in 1 CARTON (55910-548-53) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-548

Dolgencorp Inc dg health flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (55910-096-91)

650 mg/1, 20 mg/1, 10 mg/1


55910-096

Dolgencorp Inc DG Health Cold and Flu Relief 237 mL in 1 BOTTLE (55910-656-34) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55910-656



55910-656



55910-656

Dolgencorp Inc rexall dm cough and congestion relief 1 BOTTLE in 1 CARTON (55910-799-26) > 118 mL in 1 BOTTLE


55910-799

Dolgencorp Inc DG Health Childrens Mucus Relief Cough 1 BOTTLE in 1 CARTON (55910-419-26) > 118 mL in 1 BOTTLE


55910-419

Dolgencorp Inc dg health childrens mucus relief 1 BOTTLE in 1 CARTON (55910-839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


55910-839

DOH 690-292 May 2016 91 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp Inc Mucus Relief Cold, Flu and Sore Throat 237 mL in 1 BOTTLE, PLASTIC


Mucinex Cold, Flu and Sore Throat Maximum Strength

55910-233

Dolgencorp, Inc. Mucus Relief DM Max 266 mL in 1 BOTTLE, PLASTIC (55910-232-09)

400 mg/20mL, 20 mg/20mL Mucinex DM Max Maximum Strength

55910-232

Dolgencorp, Inc. (DOLLAR GENERAL &Childrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (55910-297-04) > 118 mL in 1 BOTTLE,PLASTIC



55910-297

Dolgencorp, Inc. (DOLLAR GENERAL &Childrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (55910-298-04) > 118 mL in 1 BOTTLE,PLASTIC



55910-298

Dolgencorp, Inc. (DOLLAR GENERAL &Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (55910-303-04) > 118 mL in 1 BOTTLE,PLASTIC



55910-303

Dolgencorp, Inc. (DOLLAR GENERAL &Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (55910-043-04) > 118 mL in 1 BOTTLE,PLASTIC



55910-043

Dolgencorp, Inc. (DOLLAR GENERAL &Childrens Plus Flu 1 BOTTLE, PLASTIC in 1 BOX (55910-031-04) > 118 mL in 1 BOTTLE,PLASTIC



55910-031

DOH 690-292 May 2016 92 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp, Inc. (DOLLAR GENERAL &Night Time Cold and Flu Relief 48 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


55910-471

Dolgencorp, Inc. (DOLLAR GENERAL &Nitetime 4 BLISTER PACK in 1 CARTON (55910-480-48) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55910-480

Dolgencorp, Inc. (DOLLAR GENERAL &NiteTime Cold plus Flu Releif 48 BLISTER PACK in 1 CARTON (55910-045-48) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55910-045

Dolgencorp, Inc. (DOLLAR GENERAL &Mucus Relief 266 mL in 1 BOTTLE, PLASTIC (55910-336-09)



55910-336

Dolgencorp, Inc. (DOLLAR GENERAL &Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (55910-309-04) > 118 mL in 1 BOTTLE,PLASTIC


Dolgencorp, Inc. (DOLLAR GENERAL &Mucus Relief DM 266 mL in 1 BOTTLE, PLASTIC (55910-505-08)


55910-505

Dolgencorp, Inc. (DOLLAR GENERAL &Mucus Relief DM Max 266 mL in 1 BOTTLE, PLASTIC (55910-338-09)


55910-338

Dolgencorp, Inc. (DOLLAR GENERAL &Mucus Relief Severe Cough and Congestion 266 mL in 1 BOTTLE (55910-013-09) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


55910-013

Dolgencorp, Inc. (DOLLAR GENERAL &Fast Acting Mucus Relief 266 mL in 1 BOTTLE, PLASTIC (55910-037-09)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


55910-037

DOH 690-292 May 2016 93 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp, Inc. (DOLLAR GENERAL &Triacting Daytime Cold Cough 1 BOTTLE, PLASTIC in 1 BOX (55910-



55910-378

Dolgencorp, LLC DG Health Cold Head Congestion 2 BLISTER PACK in 1 CARTON (55910-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55910-393

DOLGENCORP, LLC Cold Head Congestion 2 BLISTER PACK in 1 CARTON (55910-473-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55910-473

DOLGENCORP, LLC Night Time Cold Multi-Symptom 1 BLISTER PACK in 1 CARTON (55910-555-08) > 24 TABLET in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55910-555

Dolgencorp, LLC dg health night time cold and flu relief 296 mL in 1 BOTTLE (55910-335-38) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55910-335

Dolgencorp, LLC dg health night time cold and flu relief 355 mL in 1 BOTTLE (55910-335-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55910-335

Dolgencorp, LLC dg health cold and flu relief 10 BLISTER PACK in 1 CARTON (55910-977-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55910-977

DOH 690-292 May 2016 94 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp, LLC rexall night time cold and flu 296 mL in 1 BOTTLE (55910-990-38) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mLacetaminophen, dextromethorphan hydrobromide, doxylamine succinate

55910-990

Dolgencorp, LLC dg health cough and sore throat 237 mL in 1 BOTTLE (55910-666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55910-666

Dolgencorp, LLC dg health cold and flu relief 296 mL in 1 BOTTLE (55910-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55910-908



55910-459



55910-459



55910-459

Dolgencorp, LLC DG Health Pain Relief Cold 237 mL in 1 BOTTLE (55910-920-34) 325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL, 5 mg/15mL


55910-920

Dolgencorp, LLC Night Time Cold Max 1 BOTTLE in 1 CARTON (55910-997-20) > 240 mL in 1 BOTTLE



55910-997

DOH 690-292 May 2016 95 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp, LLC dg health cold and flu relief 237 mL in 1 BOTTLE (55910-763-34) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


55910-763

Dolgencorp, LLC dg health cold and flu relief 355 mL in 1 BOTTLE (55910-763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


55910-763

Dolgencorp, LLC dg health mucus relief 10 BLISTER PACK in 1 CARTON (55910-370-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-370

Dolgencorp, LLC Severe Cold and Mucus 1 BOTTLE in 1 CARTON (55910-995-20) > 240 mL in 1 BOTTLE


acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin

55910-995

Dolgencorp, LLC DG Health Fast Acting Mucus Relief 2 BLISTER PACK in 1 CARTON (55910-922-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-922

Dolgencorp, LLC DG Health Cold and Flu Relief 237 mL in 1 BOTTLE (55910-737-34) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


55910-737

Dolgencorp, LLC dg health cold and flu severe 12 BLISTER PACK in 1 CARTON (55910-499-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-499

DOH 690-292 May 2016 96 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp, LLC DG Health Fast Acting Mucus Relief 10 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-106

Dolgencorp, LLC dg health cold head congestion severe 2 BLISTER PACK in 1 CARTON (55910-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-234

Dolgencorp, LLC DG Health cold multi symptom 2 BLISTER PACK in 1 CARTON (55910-308-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-308

Dolgencorp, LLC DG Health Mucus Relief 10 BLISTER PACK in 1 CARTON (55910-381-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-381

DOLGENCORP, LLC Cold Multi-Symptom Severe 2 BLISTER PACK in 1 CARTON (55910-035-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-035

DOLGENCORP, LLC Cold and Flu 2 BLISTER PACK in 1 CARTON (55910-054-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55910-054

DOLGENCORP, LLC Cold Relief 2 BLISTER PACK in 1 CARTON (55910-470-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK


55910-470

DOH 690-292 May 2016 97 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDolgencorp, LLC dg health cold plus flu relief 2 BLISTER PACK in 1 CARTON



55910-994

DOLGENCORP, LLC Cough and Cold 2 BLISTER PACK in 1 CARTON (55910-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


55910-411

Dolgencorp, LLC DG Health Cough DM 1 BOTTLE in 1 CARTON (55910-384-21) > 89 mL in 1 BOTTLE


Dolgencorp, LLC DG Health Cough DM 1 BOTTLE in 1 CARTON (55910-958-21) > 89 mL in 1 BOTTLE


Dolgencorp, LLC dg health cough 296 mL in 1 BOTTLE (55910-668-38) 30 mg/30mL, 12.5 mg/30mL


55910-668

Dolgencorp, LLC dg health cough 355 mL in 1 BOTTLE (55910-668-40) 30 mg/30mL, 12.5 mg/30mL


55910-668

Dolgencorp, LLC DG Health Tussin 1 BOTTLE in 1 CARTON (55910-591-26) > 118 mL in 1 BOTTLE

30 mg/10mL, 12.5 mg/10mL

dextromethorphan hbr, doxylamine succinate

55910-591

Dolgencorp, LLC dg health tussin dm 1 BOTTLE in 1 CARTON (55910-359-26) > 118 mL in 1 BOTTLE


55910-359

Dolgencorp, LLC DG Health tussin cf 1 BOTTLE in 1 CARTON (55910-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


55910-516

Dolgencorp, LLC DG Health Triacting 1 BOTTLE in 1 CARTON (55910-444-26) > 118 mL in 1 BOTTLE


55910-444

DOH 690-292 May 2016 98 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDollar General Childrens Plus Cough and Runny Nose 118 mL in 1 BOTTLE, PLASTIC

(55910-130-04)160 mg/5mL, 1 mg/5mL, 5 mg/5mL


55910-130

Dollar General Childrens Plus Multi-Symptom Cold Grape 118 mL in 1 BOTTLE, PLASTIC (55910-145-04)



55910-145

Dollar General Night Time Original 296 mL in 1 BOTTLE, PLASTIC (55910-112-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55910-112

Dollar General Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (55910-113-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55910-113

Dollar General Cough Relief 118 mL in 1 BOTTLE, PLASTIC (55910-156-04)


55910-156

Dollar General Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (55910-072-01)

15 mg/15mL, 135 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE,

55910-072

Dollar General Tussin Sugar Free Cough 118 mL in 1 BOTTLE, PLASTIC (55910-100-04)


55910-100

Dollar General Tussin DM 118 mL in 1 BOTTLE, PLASTIC (55910-018-04)


55910-018

DOH 690-292 May 2016 99 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDomel Laboratories DOMETUSS-G 4 TABLET in 1 PACKAGE (53809-205-

04)325 mg/1, 100 mg/1, 10 mg/1, 5 mg/1

ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHRPHAN HBr, PHENYLEPHRINE HCL

53809-205

Domel Laboratories DOMETUSS-DM 30 mL in 1 BOTTLE (53809-201-01) 200 mg/5mL, 30 mg/5mL GUAIFENESIN, DEXTROMETHORPHAN HBr

53809-201

Domel Laboratories DOMETUSS-DM 118 mL in 1 BOTTLE (53809-201-04) 200 mg/5mL, 30 mg/5mL GUAIFENESIN, DEXTROMETHORPHAN HBr

53809-201

Domel Laboratories DOMETUSS-DMX 30 mL in 1 BOTTLE (53809-203-01) 200 mg/5mL, 30 mg/5mL, 10 mg/5mL

GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL

53809-203



53809-203



53809-203

DZA Brands LLC healthy accents cold head congestion 2 BLISTER PACK in 1 CARTON (55316-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55316-393

DZA Brands LLC healthy accents multi symptom cold 1 BOTTLE in 1 CARTON (55316-903-26) > 118 mL in 1 BOTTLE



55316-903

DOH 690-292 May 2016 100 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDZA Brands LLC Health Mart Multi Symptom Fever and Cold 1 BOTTLE in 1 CARTON (55316-005-

26) > 118 mL in 1 BOTTLE160 mg/5mL, 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL


55316-005

DZA Brands LLC healthy accents nighttime 1 BOTTLE in 1 CARTON (55316-908-30) > 177 mL in 1 BOTTLE

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55316-908

DZA Brands LLC healthy accents nighttime 1 BOTTLE in 1 CARTON (55316-908-38) > 296 mL in 1 BOTTLE

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55316-908

DZA Brands LLC Healthy Accents nighttime 10 BLISTER PACK in 1 CARTON (55316-977-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

55316-977

DZA Brands LLC Healthy Accents nighttime 12 BLISTER PACK in 1 CARTON (55316-977-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

55316-977

DZA Brands LLC Healthy Accents Cold and Cough 237 mL in 1 BOTTLE (55316-599-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55316-599

DZA Brands LLC healthy accents cough and sore throat 237 mL in 1 BOTTLE (55316-666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55316-666

DZA Brands LLC healthy accents nighttime cold and flu 177 mL in 1 BOTTLE (55316-459-30) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55316-459



55316-459

DOH 690-292 May 2016 101 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDZA Brands LLC healthy accents nighttime cold and flu 296 mL in 1 BOTTLE (55316-459-38) 650 mg/30mL, 30


55316-459



55316-459



55316-335



55316-335



55316-335



55316-335

DZA Brands LLC Healthy Accents Nighttime 177 mL in 1 BOTTLE (55316-041-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55316-041

DZA Brands LLC Healthy Accents Nighttime 296 mL in 1 BOTTLE (55316-041-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55316-041

DOH 690-292 May 2016 102 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDZA Brands LLC healthy accents nighttime cold and flu 12 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


55316-056

DZA Brands LLC Healthy Accents Cold and Flu 12 BLISTER PACK in 1 CARTON (55316-500-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55316-500

DZA Brands LLC Healthy Accents Mucus Relief 15 BLISTER PACK in 1 CARTON (55316-381-39) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55316-381


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55316-922


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55316-799

DZA Brands LLC Healthy Accents cold head congestion 2 BLISTER PACK in 1 CARTON (55316-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55316-234

DZA Brands LLC healthy accents daytime cold and flu 2 BLISTER PACK in 1 CARTON (55316-215-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55316-215

DOH 690-292 May 2016 103 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDZA Brands LLC healthy accents severe cold 6 POWDER, FOR SOLUTION in 1

CARTON (55316-096-91)650 mg/1, 20 mg/1, 10 mg/1


55316-096

DZA Brands LLC healthy accents daytime 6 BLISTER PACK in 1 CARTON (55316-994-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 acetaminophen, dextromethorphan hbr, phenylephrine hcl

55316-994



55316-994



55316-994



55316-994

DZA Brands LLC healthy accents daytime 177 mL in 1 BOTTLE (55316-656-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55316-656



55316-656



55316-656



55316-656

DOH 690-292 May 2016 104 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCDZA Brands LLC Healthy Accents Cold 2 BLISTER PACK in 1 CARTON



55316-402

DZA Brands LLC healthy accents cold and cough DM 1 BOTTLE in 1 CARTON (55316-987-26) > 118 mL in 1 BOTTLE



55316-987

DZA Brands LLC Healthy Accents Childrens Cold and Cough 1 BOTTLE in 1 CARTON (55316-031-26) > 118 mL in 1 BOTTLE

2 mg/10mL, 10 mg/10mL, 5 mg/10mL


55316-031

DZA Brands LLC Healthy Accents Tussin Cough 1 BOTTLE in 1 CARTON (55316-300-26) > 118 mL in 1 BOTTLE


55316-300

DZA Brands LLC healthy accents cough relief 1 BOTTLE in 1 CARTON (55316-384-21) > 89 mL in 1 BOTTLE


DZA Brands LLC Healthy Accents Night Time Cough 296 mL in 1 BOTTLE (55316-668-38) 30 mg/30mL, 12.5 mg/30mL


55316-668

DZA Brands LLC Healthy Accents Night Time Cough 355 mL in 1 BOTTLE (55316-668-40) 30 mg/30mL, 12.5 mg/30mL


55316-668

DZA Brands LLC healthy accents tussin dm 1 BOTTLE in 1 CARTON (55316-578-26) > 118 mL in 1 BOTTLE


55316-578



55316-359



55316-359

DZA Brands LLC healthy accents tussin cf 1 BOTTLE in 1 CARTON (55316-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


55316-516

DOH 690-292 May 2016 105 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDC

Eagle Distributors,Inc ConRX DayTime 50 POUCH in 1 BOX (68737-238-22) > 2 TABLET in 1 POUCH

5 mg/1, 325 mg/1, 10 mg/1, 200 mg/1

Phenylephrine Hydrochloride, Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin

68737-238

Eagle Distributors,Inc. ConRx NightTime 50 POUCH in 1 BOX (68737-239-23) > 2 TABLET in 1 POUCH

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate

68737-239

Eagle Distributors,Inc. ConRx 50 POUCH in 1 BOX (68737-227-11) > 2 TABLET in 1 POUCH

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


68737-227

Eagle Distributors,Inc. ConRx Cold 50 POUCH in 1 BOX (68737-232-16) > 2 TABLET in 1 POUCH

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


68737-232

Edwards Pharmaceuticals, Inc. Rynex 10 mL in 1 BOTTLE (0485-0204-10) 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL

Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

0485-0204

Edwards Pharmaceuticals, Inc. Rynex 473 mL in 1 BOTTLE (0485-0204-16) 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL

Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

0485-0204

E

DOH 690-292 May 2016 106 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCEDWARDS PHARMACEUTICALS, INC. ED-A-HIST DM 100 TABLET, COATED in 1 BOTTLE,

PLASTIC (0485-0240-01)4 mg/1, 10 mg/1, 10 mg/1 CHLORPHENIRAMINE

MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

0485-0240

EDWARDS PHARMACEUTICALS, INC. ED A-HIST DM 473 mL in 1 BOTTLE, PLASTIC (0485-0171-16)


DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE

0485-0171

EFFICIENT LABORATORIES INC Rompe Pecho Max Multi Symptoms 1 BOTTLE in 1 CARTON (58593-828-08) > 237 mL in 1 BOTTLE


Acetaminophen, Dextromethophan HBr, Phenylephrine HCl, Guaifenesin

58593-828

Efficient Laboratories Inc Rompe Pecho 178 mL in 1 BOTTLE (58593-225-06) 10 mg/5mL, 10 mg/5mL, 10 mg/5mL

Dextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride

58593-225

Efficient Laboratories Inc Rompe Pecho 118 mL in 1 BOTTLE (58593-275-04) 10 mg/5mL, 100 mg/5mL Dextromethorphan HBr, Guaifenesin

58593-275


58593-275


58593-275

Efficient Laboratories Inc Rompe Pecho 10 mL in 1 POUCH (58593-275-10) 10 mg/5mL, 100 mg/5mL Dextromethorphan HBr, Guaifenesin

58593-275

DOH 690-292 May 2016 107 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCEfficient Laboratories Inc Rompe Pecho 118 mL in 1 BOTTLE (58593-235-04) 10 mg/5mL, 100 mg/5mL, 5

mg/5mLDextromethorphan HBr, Guaifenesin, Phenylephrine HCL

58593-235



58593-235



58593-235

Efficient Laboratories Inc. Mielim y mas 118 mL in 1 BOTTLE (58593-295-04) 15 mg/5mL Dextromethorphan 58593-295

Efficient Laboratories Inc. Mielim y mas 178 mL in 1 BOTTLE (58593-295-06) 15 mg/5mL Dextromethorphan 58593-295

Equaline Childrens Plus Cough and Runny Nose 118 mL in 1 BOTTLE, PLASTIC (41163-130-04)


ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE,

41163-130

Equaline Night Time Original 296 mL in 1 BOTTLE, PLASTIC (41163-180-19)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41163-180

Equaline Night Time Original 177 mL in 1 BOTTLE, PLASTIC (41163-180-16)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41163-180

DOH 690-292 May 2016 108 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCEqualine Night Time Cherry 177 mL in 1 BOTTLE, PLASTIC

(41163-182-16)500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41163-182

Equaline Cough Relief 118 mL in 1 BOTTLE, PLASTIC (41163-156-04)


41163-156

Equaline Tussin Cough Long Acting 118 mL in 1 BOTTLE, PLASTIC (41163-098-04)


41163-098

EQUALINE (SuperValu) Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (41163-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41163-071

EQUALINE (SuperValu) Nighttime Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (41163-480-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41163-480

EQUALINE (SuperValu) Mucus Relief Cold Flu Sore Throat 117 mL in 1 BOTTLE (41163-036-06) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


41163-036

EQUALINE (SuperValu) Daytime Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (41163-470-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41163-470

EQUALINE (SuperValu) Daytime Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (41163-068-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41163-068

DOH 690-292 May 2016 109 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCEQUALINE (SuperValu) Mucus Relief 177 mL in 1 BOTTLE, PLASTIC



41163-035

EQUALINE (SuperValu) Mucus Relief Severe Congestion Cough 117 mL in 1 BOTTLE (41163-037-06) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


41163-037

EQUALINE (SuperValu) Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (41163-047-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


41163-047

EQUATE (Walmart Stores, Inc.) NiteTime Cold and Flu 2 BOTTLE, PLASTIC in 1 KIT (49035-044-24) > 355 mL in 1 BOTTLE,PLASTIC

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49035-044

EQUATE (Walmart Stores, Inc.) Daytime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (49035-466-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49035-466

EQUATE (Walmart Stores, Inc.) Mucus Relief Severe Congestion and Cough 266 mL in 1 BOTTLE, PLASTIC (49035-037-09)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


49035-037

EQUATE (Walmart Stores, Inc.) Tussin CF 1 BOTTLE, PLASTIC in 1 BOX (49035-412-08) > 237 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


49035-412

Exchange Select Mucus Relief Cold, Flu and Sore Throat 177 mL in 1 BOTTLE, PLASTIC (55301-233-06)


Mucinex Fast Max Cold, Flu and Sore Throat Maximum Strength

55301-233

DOH 690-292 May 2016 110 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCExchange Select Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC

(55301-234-06)400 mg/20mL, 20 mg/20mL, 10 mg/20mL

Mucinex Fast Max Severe Congestion and Cough Maximum Strength

55301-234

Family Dollar Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (55319-140-31)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate

55319-140

Family Dollar Night Time Original 296 mL in 1 BOTTLE, PLASTIC (55319-146-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate

55319-146

Family Dollar Nighttime Multi-Symptom Cold and Flu Relief 1 BLISTER PACK in 1 CARTON (55319-535-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55319-535

Family Dollar Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (55319-660-21) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55319-660

Family Dollar Multi-Symptom Cold Flu and Sore Throat 2 BLISTER PACK in 1 PACKAGE (55319-616-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55319-616

Family Dollar Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC (55319-210-48)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55319-210

Family Dollar Cold and Flu Relief 1 BLISTER PACK in 1 CARTON (55319-659-21) > 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55319-659

F

DOH 690-292 May 2016 111 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFamily Dollar Non-Drowsy Daytime Multi-Symptom Cold and Flu 2 BLISTER PACK in 1 CARTON



55319-534

Family Dollar Day Time 296 mL in 1 BOTTLE, PLASTIC (55319-341-61)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen.Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

55319-341

Family Dollar Cough and Cold HBP 2 BLISTER PACK in 1 CARTON (55319-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK

4 mg/1, 30 mg/1 chlorpheniramine maleate and dextromethorphan hbr

55319-411

Family Dollar Cough Relief 118 mL in 1 BOTTLE, PLASTIC (55319-310-44)


55319-310

Family Dollar Night Time Cough Cherry 296 mL in 1 BOTTLE, PLASTIC (55319-042-01)


55319-042

Family Dollar Mucus Relief DM 1 BOTTLE, PLASTIC in 1 CARTON (55319-533-01) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC


55319-533

Family Dollar Tussin DM 237 mL in 1 BOTTLE, PLASTIC (55319-040-88)


55319-040

Family Dollar Tussin CF 118 mL in 1 BOTTLE, PLASTIC (55319-241-14)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


55319-241

Family Dollar (FAMILY WELLNESS) Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (55319-304-04) > 118 mL in 1 BOTTLE,PLASTIC



55319-304

DOH 690-292 May 2016 112 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFamily Dollar (FAMILY WELLNESS) Cold and Flu 296 mL in 1 BOTTLE, PLASTIC

(55319-342-10)500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55319-342

Family Dollar (FAMILY WELLNESS) Cold and Flu 296 mL in 1 BOTTLE, PLASTIC (55319-346-10)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55319-346

Family Dollar (FAMILY WELLNESS) Nighttime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (55319-480-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55319-480

Family Dollar (FAMILY WELLNESS) Nighttime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (55319-480-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55319-480

Family Dollar (FAMILY WELLNESS) Nighttime Multi Symptom Cold and Flu Relief 48 BLISTER PACK in 1 CARTON (55319-771-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55319-771

Family Dollar (FAMILY WELLNESS) Severe cold and flu 237 mL in 1 BOTTLE, PLASTIC (55319-416-08)


Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI

55319-416

Family Dollar (FAMILY WELLNESS) Severe Cold Multi Symptom 237 mL in 1 BOTTLE, PLASTIC (55319-001-08)



55319-001

DOH 690-292 May 2016 113 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFamily Dollar (FAMILY WELLNESS) Daytime Severe Cold and Cough Relief 245 mL in 1 BOTTLE, PLASTIC

(55319-316-08)650 mg/30mL, 20 mg/30mL, 10 mg/30mL


55319-316

Family Dollar (FAMILY WELLNESS) Daytime Cold and Flu 296 mL in 1 BOTTLE, PLASTIC (55319-066-10)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55319-066

Family Dollar (FAMILY WELLNESS) Non-Drowsy Daytime Multi Symptom Cold and Flu Relief

16 BLISTER PACK in 1 CARTON (55319-468-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55319-468

Family Dollar (FAMILY WELLNESS) Daytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (55319-470-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55319-470

Family Dollar (FAMILY WELLNESS) Daytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (55319-470-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55319-470

Family Dollar (FAMILY WELLNESS) Childrens Cold and Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (55319-313-04) > 118 mL in 1 BOTTLE,PLASTIC

2 mg/10mL, 10 mg/10mL, 5 mg/10mL


55319-313

Family Dollar (FAMILY WELLNESS) Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (55319-336-06)



55319-336

Family Dollar (FAMILY WELLNESS) Night Time Cough 296 mL in 1 BOTTLE, PLASTIC (55319-345-10)

30 mg/30mL, 12.5 mg/30mL


55319-345

DOH 690-292 May 2016 114 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFamily Dollar (FAMILY WELLNESS) Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (55319-



55319-385

Family Dollar (FAMILY WELLNESS) Mucus Relief Cough 1 BOTTLE, PLASTIC in 1 BOX (55319-294-04) > 118 mL in 1 BOTTLE,PLASTIC


55319-294

Family Dollar (FAMILY WELLNESS) Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (55319-337-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


55319-337

Family Dollar (FAMILY WELLNESS) Multi Symptom Cold CF 1 BOTTLE, PLASTIC in 1 BOX (55319-382-04) > 118 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


55319-382

Family Dollar (FAMILY WELLNESS) Cold and Cough Day Time 1 BOTTLE, PLASTIC in 1 BOX (55319-378-04) > 118 mL in 1 BOTTLE,PLASTIC


55319-378

Family Dollar (FAMILY WELLNESS) Mucus Relief 1 BOTTLE, PLASTIC in 1 BOX (55319-109-30) > 30 TABLET in 1 BOTTLE,PLASTIC


55319-109

FAZ Marketing Multi Symptom Cold 1 BOTTLE in 1 BOX (50061-381-04) > 118 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


50061-381

FAZ Marketing Multi Symptom Cold CF 1 BOTTLE, PLASTIC in 1 BOX (50061-412-04) > 118 mL in 1 BOTTLE,PLASTIC

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


50061-412

First Aid Beverages, Inc. First Aid Shot Therapy Cold Relief 40 mL in 1 BOTTLE, PLASTIC (57815-031-01)

20 mg/40mL, 10 mg/40mL, 8.5 mg/40mL

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Menthol

57815-031

DOH 690-292 May 2016 115 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFood Lion Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC

(55316-155-08)325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55316-155

Food Lion Cough Relief 118 mL in 1 BOTTLE, PLASTIC (55316-156-04)


55316-156

Food Lion Childrens Relief Cherry 118 mL in 1 BOTTLE, PLASTIC (55316-158-04)


55316-158

FORTUNE PHARMACAL COMPANY LI COLTALIN-DM 24 TABLET in 1 CARTON (51467-007-01)

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


51467-007

Freds Inc Childrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (55315-297-04) > 118 mL in 1 BOTTLE,PLASTIC



55315-297

Freds Inc Childrens Plus Flu 1 BOTTLE, PLASTIC in 1 BOX (55315-300-04) > 118 mL in 1 BOTTLE,PLASTIC



55315-300

DOH 690-292 May 2016 116 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFreds Inc Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (55315-




55315-304

Freds Inc Night time multi symptom cold/flu relief 2 BLISTER PACK in 1 CARTON (55315-480-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55315-480

Freds Inc Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (55315-342-12)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55315-342


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55315-344

Freds Inc Night Time Cold and Flu Relief 16 BLISTER PACK in 1 CARTON (55315-471-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55315-471

Freds Inc Daytime Flu Relief Therapy 245 mL in 1 BOTTLE, PLASTIC (55315-316-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL


55315-316

Freds Inc Daytime cold and flu relief 2 BLISTER PACK in 1 CARTON (55315-468-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55315-468

DOH 690-292 May 2016 117 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFreds Inc Non Drowsy Day Time 2 BLISTER PACK in 1 CARTON



55315-470


325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55315-066

Freds Inc Childrens Dibromm Cold and Cough 1 BOTTLE, PLASTIC in 1 BOX (55315-313-04) > 118 mL in 1 BOTTLE,PLASTIC

2 mg/10mL, 10 mg/10mL, 5 mg/10mL


55315-313

Freds Inc Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (55315-309-04) > 118 mL in 1 BOTTLE,PLASTIC


Freds Inc Nighttime Cough Relief 355 mL in 1 BOTTLE, PLASTIC (55315-345-12)

30 mg/30mL, 12.5 mg/30mL


55315-345

Freds Inc Adult Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (55315-384-04) > 118 mL in 1 BOTTLE,PLASTIC


55315-384

Freds Inc Adult Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (55315-385-08) > 237 mL in 1 BOTTLE,PLASTIC


55315-385

Freds Inc Tussin Multi Symptom Cold CF 1 BOTTLE, PLASTIC in 1 BOX (55315-382-04) > 118 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


55315-382

Freds Inc Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (55315-337-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


55315-337

DOH 690-292 May 2016 118 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFRED'S, INC. Nighttime Cold Head Congestion 2 BLISTER PACK in 1 CARTON


325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55315-473

Fred's, Inc. COLD and FLU Nighttime Relief 2 BOTTLE in 1 CARTON (55315-357-31) > 355 mL in 1 BOTTLE

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55315-357

Fred's, Inc. COLD and FLU Nighttime Relief 355 mL in 1 BOTTLE (55315-358-31) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55315-358

Fred's, Inc. NightTime Relief Severe Cold and Flu 354 mL in 1 BOTTLE (55315-365-31) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL

acetaminophen, doxylamine succinate, phenylephrine hcl and dextromethorphan hbr

55315-365

Fred's, Inc. Daytime Relief Severe Cold and Flu 354 mL in 1 BOTTLE (55315-359-31) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


55315-359

FRED'S, INC. Cold Head Congestion 2 BLISTER PACK in 1 CARTON (55315-503-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin

55315-503

FRED'S, INC. Cold 2 BLISTER PACK in 1 CARTON (55315-560-08) > 12 TABLET in 1 BLISTER PACK


55315-560

FRED'S, INC. Cold Head Congestion Daytime 2 BLISTER PACK in 1 BOX (55315-047-08) > 12 TABLET, FILM COATEDin 1 BLISTER PACK


55315-047

DOH 690-292 May 2016 119 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCFRED'S, INC. Cough and Cold HBP 2 BLISTER PACK in 1 CARTON



55315-411

Gadal Laboratories Inc Broncomar 1 BOTTLE in 1 CARTON (53113-215-06) > 177 mL in 1 BOTTLE

250 mg/10mL, 13.33 mg/10mL, 200 mg/10mL, 5 mg/10mL


53113-215



53113-216



53113-217

Gadal Laboratories Inc Gadavyt Cough 118 mL in 1 BOTTLE (53113-557-04) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

53113-557

Geiss, Destin & Dunn, Inc (GoodsenseNighttime 2 BLISTER PACK in 1 CARTON (50804-480-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


50804-480

Geiss, Destin & Dunn, Inc (GoodsenseNighttime 2 BLISTER PACK in 1 CARTON (50804-480-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


50804-480

Genomma Lab USA Next Night Time 10 CAPSULE, LIQUID FILLED in 1 BOX (50066-357-09)

325 mg/1, 15 mg/1, 6.25 mg/1


50066-357

Genomma Lab USA Next Day Time 10 CAPSULE, LIQUID FILLED in 1 BOX (50066-356-09)


50066-356

G

DOH 690-292 May 2016 120 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCGenomma Lab USA, Inc Tukol Maxium Strength Cough and Mucus Relief 20 BLISTER PACK in 1 CARTON


10 mg/1, 200 mg/1 DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

50066-601

Genomma Lab USA, Inc. Tukol Multi Symptom Cold 118 mL in 1 BOTTLE (50066-504-24) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


50066-504

Genomma Lab USA, Inc. Tukol X-Pecto Miel 118 mL in 1 BOTTLE (50066-533-24) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


50066-533

Genomma Lab USA, Inc. Tukol A 118 mL in 1 BOTTLE (50066-536-24) 5 mg/5mL, 50 mg/5mL, 2.5 mg/5mL


50066-536

Geri-Care Pharmaceuticals, Corp Guaiasorb DM 118 mL in 1 BOTTLE, PLASTIC (57896-756-04)


57896-756

Gil Pharmaceutical Corp GILTUSS PEDIATRIC 1 BOTTLE in 1 CARTON (58552-121-02) > 60 mL in 1 BOTTLE

7.5 mg/mL, 88 mg/mL, 2.5 mg/mL

dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

58552-121

DOH 690-292 May 2016 121 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCGil Pharmaceutical Corp Giltuss 30 mL in 1 BOTTLE (58552-122-01) 28 mg/5mL, 388 mg/5mL,

10 mg/5mLDextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride

58552-122

Gil Pharmaceutical Corp Giltuss 237 mL in 1 BOTTLE (58552-122-08) 28 mg/5mL, 388 mg/5mL, 10 mg/5mL


58552-122

Gil Pharmaceutical Corp GILTUSS TOTAL RELEASE 100 TABLET in 1 BOTTLE (58552-317-01)

388 mg/1, 28 mg/1, 10 mg/1

Guaifenesin, Dextromethorphan HBr, and Phenylephrine HCl

58552-317

Gil Pharmaceutical Corp GILTUSS TOTAL RELEASE 12 BLISTER PACK in 1 CARTON (58552-317-02) > 2 TABLET in 1 BLISTER PACK

388 mg/1, 28 mg/1, 10 mg/1

Guaifenesin, Dextromethorphan HBr, and Phenylephrine HCl

58552-317

GlaxoSmithKline Consumer Healthca Theraflu 6 PACKET in 1 CARTON (0067-7917-06) > 1 POWDER, FOR SOLUTION in1 PACKET

650 mg/1, 20 mg/1, 10 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE

0067-7917

Glendale Inc Glenmax PEB DM FORTE 473 mL in 1 BOTTLE, PLASTIC (70147-223-16)


DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and BROMPHENIRAMINE MALEATE

70147-223

Glendale Inc Glenmax PEB DM 473 mL in 1 BOTTLE, PLASTIC (70147-230-16)


DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and BROMPHENIRAMINE MALEATE

70147-230

DOH 690-292 May 2016 122 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCGlendale Inc Glentuss 473 mL in 1 BOTTLE, PLASTIC

(70147-233-16)15 mg/5mL, 30 mg/5mL, 6.25 mg/5mL

DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DOXYLAMINE SUCCINATE

70147-233

GM Pharmaceuticals, Inc. TEXACLEAR DAYTIME COUGH COLD/FLU 237 mL in 1 BOTTLE, PLASTIC (58809-391-08)


Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

58809-391

GM PHARMACEUTICALS,INC VANACOF DM 240 mL in 1 BOTTLE (58809-555-08) 18 mg/15mL, 200 mg/15mL, 10 mg/15mL


58809-555

Good Neighbor Pharmacy Childrens Plus Multi-Symptom Cold Grape 118 mL in 1 BOTTLE, PLASTIC (46122-036-26)


Childrens Tylenol Plus Multi-Symptom Cold

46122-036

Good Neighbor Pharmacy Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC (24385-155-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


24385-155

Good Neighbor Pharmacy Tussin Cough Long Acting 118 mL in 1 BOTTLE, PLASTIC (24385-098-04)


24385-098

Good Neighbor Pharmacy Cough Relief 118 mL in 1 BOTTLE, PLASTIC (24385-156-04)


24385-156

Good Neighbor Pharmacy Cough Relief Grape 118 mL in 1 BOTTLE, PLASTIC (24385-159-04)


24385-159

Good Neighbor Pharmacy Childrens Mucus Relief 118 mL in 1 BOTTLE, PLASTIC (24385-158-04)


24385-158

DOH 690-292 May 2016 123 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCGood Neighbor Pharmacy Triacting Day Time 118 mL in 1 BOTTLE, PLASTIC

(24385-148-04)5 mg/5mL, 2.5 mg/5mL DEXTROMETHORPHAN

HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

24385-148

Good Neighbor Pharmacy Mucus Relief DM Max 177 mL in 1 BOTTLE, PLASTIC (46122-218-30)


46122-218

Good Neighbor Pharmacy Mucus Relief Cold, Flu and Sore Throat 177 mL in 1 BOTTLE, PLASTIC (46122-217-30)



46122-217

Good Neighbor Pharmacy Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (46122-219-30)

400 mg/20mL, 20 mg/20mL, 10 mg/20mL

Mucinex Congestion and Cough Maximum Strength

46122-219

Good Sense (Geiss, Destin & Dunn, InDaytime 16 BLISTER PACK in 1 CARTON (50804-468-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


50804-468



50804-468



50804-470



50804-470

Good Sense (Geiss, Destin & Dunn, InMucus Relief DM 1 BOTTLE, PLASTIC in 1 BOX (50804-109-30) > 30 TABLET, COATED in 1BOTTLE, PLASTIC


50804-109

DOH 690-292 May 2016 124 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCGoodSense Cold and Flu Severe 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


50804-163

GoodSense Pressure Plus Pain PE Plus Cold 2 BLISTER PACK in 1 CARTON (50804-174-02) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


50804-174

GoodSense Cold Multi-Symptom 2 BLISTER PACK in 1 CARTON (50804-138-04) > 12 TABLET, COATED in 1 BLISTER PACK


50804-138

GOYESCAS OF FLA Goyescas 7 Syrups Original 1 BOTTLE in 1 BOX (11856-0001-1) > 177 mL in 1 BOTTLE



11856-0001

GOYESCAS OF FLA Goyescas Broncovac 3 1 BOTTLE in 1 BOX (11856-0025-1) > 177 mL in 1 BOTTLE

100 mg/5mL, 5 mg/5mL, 10 mg/5mL


11856-0025

GOYESCAS OF FLA Goyescas 7 Syrups with Bee Honey 1 BOTTLE in 1 BOX (11856-0026-1) > 177 mL in 1 BOTTLE

100 mg/5mL, 5 mg/5mL, 10 mg/5mL

Dextrmethorphan, Guaifenesin, Phenylephrine

11856-0026

GOYESCAS OF FLA Goyescas 7 Syrups Alcohol and Sugar Free 1 BOTTLE in 1 BOX (11856-0031-1) > 177 mL in 1 BOTTLE

100 mg/5mL, 5 mg/5mL, 10 mg/5mL


11856-0031




11856-0016


5 mg/5mL, 100 mg/5mL, 10 mg/5mL

Dextromethorphan, Guafenesin, Phenylephrine

11856-0017

DOH 690-292 May 2016 125 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCGrandall Distributing Co., Inc. Adult Flu and Cough sanaflu 12 CAPSULE, GELATIN COATED in 1

BOX (48201-001-12)250 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


48201-001

Grandall Distributing Co., Inc. sanaflu Night-Time Xtreme Multi-Symptom Cold/Flu Relief Cherry Flavor


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE

48201-008

GREAT LAKES WHOLESALE, MARKETI Multi-Symptom Cold Daytime 2 BLISTER PACK in 1 CARTON (64092-870-24) > 12 TABLET in 1 BLISTER PACK


64092-870

Green Choice for Life Green Tussin SUGAR FREE 180 mL in 1 CARTON (55287-101-06)

10 mg/15mL, 100 mg/15mL Green Tussin SUGAR FREE DM 55287-101

Green Choice for Life Green Tussin 1 BOTTLE in 1 CARTON (55287-100-06) > 180 mL in 1 BOTTLE

100 mg/15mL, 10 mg/15mL Guaifenesin, Dextromethorphan HBr

55287-100

Greenbrier International NiteTime 1 BLISTER PACK in 1 CARTON (33992-0621-0) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


33992-0621

Greenbrier International Daytime 1 BLISTER PACK in 1 CARTON (33992-0611-0) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride

33992-0611

GREENBRIER INTERNATIONAL, INC. Cold and Flu Severe 2 BLISTER PACK in 1 CARTON (33992-5031-8) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


33992-5031

DOH 690-292 May 2016 126 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCGREENBRIER INTERNATIONAL, INC. Cold Multi-Symptom 1 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


33992-0503

GREENBRIER INTERNATIONAL, INC. Cold Multi-Symptom 2 BLISTER PACK in 1 CARTON (33992-0503-8) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


33992-0503

Guardian Drug Company Tussnex FM Cold, Flu and Sore Throat 177 mL in 1 CARTON (53041-618-58)


Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

53041-618

Guardian Drug Company Childrens Tussnex 1 BOTTLE in 1 CARTON (53041-622-03) > 118 mL in 1 BOTTLE



53041-622

Guardian Drug Company Childrens Metapp Daytime 1 BOTTLE in 1 CARTON (53041-577-03) > 118 mL in 1 BOTTLE



53041-577

Guardian Drug Company Maximum strength Tussnex FM DM Max 177 mL in 1 BOTTLE (53041-628-58) 20 mg/20mL, 400 mg/20mL Dextromethorphan HBr, Guaifenesin

53041-628

Guardian Drug Company Childrens Tussnex Multi-symptom cold 1 BOTTLE in 1 CARTON (53041-615-03) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


53041-615

Guardian Drug Company Tussnex FM Severe cough and congestion 177 mL in 1 BOTTLE (53041-617-58) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


53041-617

DOH 690-292 May 2016 127 of 379


H E B rx act cough and sore throat 237 mL in 1 BOTTLE (37808-698-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

37808-698

H E B Cold and Cough 237 mL in 1 BOTTLE (37808-800-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

37808-800

H E B Cold and Cough 237 mL in 1 BOTTLE (37808-902-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


37808-902

H E B rx act nighttime 2 BLISTER PACK in 1 CARTON (37808-977-60) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37808-977

H E B rx act cough and sore throat 237 mL in 1 BOTTLE (37808-666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


37808-666

H E B night time 12 BLISTER PACK in 1 CARTON (37808-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37808-056

H E B night time 12 BLISTER PACK in 1 CARTON (37808-061-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37808-061

H E B night time 237 mL in 1 BOTTLE (37808-335-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37808-335



37808-335

H

DOH 690-292 May 2016 128 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCH E B night time 296 mL in 1 BOTTLE (37808-459-38) 650 mg/30mL, 30


37808-459



37808-459

H E B night time 2 BOTTLE in 1 PACKAGE (37808-459-50) > 355 mL in 1 BOTTLE

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37808-459

H E B Night Time Liquid Caps 2 BLISTER PACK in 1 CARTON (37808-480-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37808-480

H E B nighttime severe cold and flu 355 mL in 1 BOTTLE (37808-763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


37808-763

H E B cold multi symptom 237 mL in 1 BOTTLE (37808-920-34) 325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL, 5 mg/15mL


37808-920

H E B daytime severe cold and flu 355 mL in 1 BOTTLE (37808-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


37808-603

H E B cold relief 2 BLISTER PACK in 1 CARTON (37808-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37808-234

DOH 690-292 May 2016 129 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCH E B cold relief 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37808-308

H E B MAX Cold, Flu, and Sore Throat 117 mL in 1 BOTTLE (37808-316-25) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL

ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL

37808-316

H E B Rx Act Flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (37808-096-91)

650 mg/1, 20 mg/1, 10 mg/1


37808-096

H E B Flu Relief Therapy 245 mL in 1 BOTTLE, PLASTIC (37808-016-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL


37808-016

H E B Day Time Cold Flu Relief 2 BLISTER PACK in 1 CARTON (37808-470-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37808-470

H E B Rx Act Cold Head Congestion 2 BLISTER PACK in 1 CARTON (37808-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


37808-402

H E B flu and severe cold and cough 6 POUCH in 1 CARTON (37808-444-91) > 1 POWDER, FOR SOLUTION in1 POUCH

650 mg/1, 20 mg/1, 10 mg/1


37808-444

DOH 690-292 May 2016 130 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCH E B DayTime 296 mL in 1 BOTTLE (37808-656-38) 325 mg/15mL, 10


37808-656

H E B DayTime 355 mL in 1 BOTTLE (37808-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


37808-656

H E B Day Time 2 BLISTER PACK in 1 CARTON (37808-702-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37808-702

H E B day time 10 BLISTER PACK in 1 CARTON (37808-994-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37808-994

H E B day time 12 BLISTER PACK in 1 CARTON (37808-994-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37808-994

H E B cold and cough 1 BOTTLE in 1 CARTON (37808-987-26) > 118 mL in 1 BOTTLE



37808-987

H E B Tussin Cough 1 BOTTLE in 1 CARTON (37808-504-34) > 237 mL in 1 BOTTLE


37808-504

H E B Cough DM 1 BOTTLE in 1 CARTON (37808-384-21) > 89 mL in 1 BOTTLE


H E B Cough DM 1 BOTTLE in 1 CARTON (37808-384-28) > 148 mL in 1 BOTTLE


H E B RX Act Tussin 1 BOTTLE in 1 CARTON (37808-300-34) > 237 mL in 1 BOTTLE


37808-300

DOH 690-292 May 2016 131 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCH E B night time 237 mL in 1 BOTTLE (37808-668-34) 30 mg/30mL, 12.5

mg/30mLDextromethorphan HBr, Doxylamine succinate

37808-668

H E B night time 296 mL in 1 BOTTLE (37808-668-38) 30 mg/30mL, 12.5 mg/30mL


37808-668

H E B night time 355 mL in 1 BOTTLE (37808-668-40) 30 mg/30mL, 12.5 mg/30mL


37808-668

H E B tussin cough and chest congestion DM 1 BOTTLE in 1 CARTON (37808-799-26) > 118 mL in 1 BOTTLE


37808-799

H E B tussin cough and chest congestion DM 1 BOTTLE in 1 CARTON (37808-799-34) > 237 mL in 1 BOTTLE


37808-799

H E B daytime 296 mL in 1 BOTTLE (37808-818-38) 10 mg/15mL, 200 mg/15mL Dextromethorphan HBr, Guaifenesin

37808-818

H E B Tussin DM 1 BOTTLE in 1 CARTON (37808-359-26) > 118 mL in 1 BOTTLE


37808-359



37808-359



37808-359

H E B tussin dm 1 BOTTLE in 1 CARTON (37808-578-26) > 118 mL in 1 BOTTLE


37808-578

H E B Tussin 1 BOTTLE in 1 CARTON (37808-601-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


37808-601

H E B Tussin 1 BOTTLE in 1 CARTON (37808-601-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


37808-601

H E B Rx Act Tussin CF 1 BOTTLE in 1 CARTON (37808-516-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


37808-516

DOH 690-292 May 2016 132 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCH E B Rx Act Tussin CF 1 BOTTLE in 1 CARTON (37808-516-



37808-516

H E B H E B MAX SEVERE CONGESTION and COUGH 177 mL in 1 BOTTLE (37808-317-25) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


37808-317

H.E.B Night Time Original 296 mL in 1 BOTTLE, PLASTIC (59640-112-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


59640-112

H.E.B Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (59640-113-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromidem, Doxylamine Succinate

59640-113

H.E.B Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC (59640-155-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


59640-155

H.E.B Tussin Cough Long Acting 237 mL in 1 BOTTLE, PLASTIC (59640-098-08)


59640-098



59640-072



59640-072

DOH 690-292 May 2016 133 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCH.E.B. Childrens Mucus Relief Cherry 118 mL in 1 BOTTLE, PLASTIC

(59640-158-04)5 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN


59640-158

Han Kook Shin Yak Pharmaceutical C HANSHINNOCOL 10 BOX in 1 CARTON (53153-101-05) > 3 BOTTLE in 1 BOX (53153-101-04) > 30 mL in 1 BOTTLE (53153-101-01)

200 mg/30mL, 2.5 mg/30mL, 15 mg/30mL

Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide

53153-101

Han Kook Shin Yak Pharmaceutical C HANSHINNOCOL 1 BLISTER PACK in 1 BOX (53153-102-05) > 10 CAPSULE in 1 BLISTERPACK (53153-102-04) > 500 mg in 1CAPSULE (53153-102-01)

100 mg/500mg, 1.25 mg/500mg, 7.5 mg/500mg

Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide

53153-102

Hannaford Brothers Company plus multi symptom cold 1 BOTTLE in 1 CARTON (41268-903-26) > 118 mL in 1 BOTTLE



41268-903

Hannaford Brothers Company Night Time 2 BLISTER PACK in 1 CARTON (41268-977-60) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41268-977

Hannaford Brothers Company NightTime 177 mL in 1 BOTTLE (41268-041-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41268-041

Hannaford Brothers Company NightTime 296 mL in 1 BOTTLE (41268-041-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41268-041

DOH 690-292 May 2016 134 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHannaford Brothers Company daytime 1 BLISTER PACK in 1 CARTON



41268-215

Hannaford Brothers Company daytime 2 BLISTER PACK in 1 CARTON (41268-215-60) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41268-215

Hannaford Brothers Company Night Time 296 mL in 1 BOTTLE (41268-668-38) 15 mg/15mL, 6.25 mg/15mL


41268-668

Hannaford Brothers Company tussin cough dm 1 BOTTLE in 1 CARTON (41268-359-26) > 118 mL in 1 BOTTLE


41268-359



41268-359



41268-359

Hannaford Brothers Company Tussin Cough DM 1 BOTTLE in 1 CARTON (41268-578-26) > 118 mL in 1 BOTTLE


41268-578

Harmon Stores Inc. harmon face values night time relief 355 mL in 1 BOTTLE (63940-335-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


63940-335



63940-459



63940-459

DOH 690-292 May 2016 135 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHarmon Stores Inc. Harmon Face Values Tussin DM 1 BOTTLE in 1 CARTON (63940-359-



Harmon Stores Inc. harmon face values tussin cf 1 BOTTLE in 1 CARTON (63940-516-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


63940-516

Harris Teeter, LLC Harris Teeter NightTime Cold and Flu 12 BLISTER PACK in 1 CARTON (69256-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


69256-056

Harris Teeter, LLC Harris Teeter NightTime 237 mL in 1 BOTTLE (69256-335-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


69256-335



69256-335



69256-459



69256-459

Harris Teeter, LLC Harris Teeter DayTime 355 mL in 1 BOTTLE (69256-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


69256-656

Harris Teeter, LLC DayTime Cold Flu 24 BLISTER PACK in 1 CARTON (69256-468-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


69256-468

DOH 690-292 May 2016 136 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHarris Teeter, LLC Cold and Flu Relief 24 BLISTER PACK in 1 CARTON



69256-470

Harris Teeter, LLC Harris Teeter Day Time 12 BLISTER PACK in 1 CARTON (69256-994-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


69256-994

Harris Teeter, LLC Harris Teeter Cough DM 1 BOTTLE in 1 CARTON (69256-384-21) > 89 mL in 1 BOTTLE


Harris Teeter, LLC Harris Teeter Tussin 1 BOTTLE in 1 CARTON (69256-359-34) > 237 mL in 1 BOTTLE


69256-359



69256-799


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


69256-516

Health Care Products Diabetic Tussin Nighttime Cold and Flu 1 BOTTLE in 1 CARTON (61787-452-04) > 118 mL in 1 BOTTLE

325 mg/5mL, 10 mg/5mL, 12.5 mg/5mL

Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl

61787-452

Health Care Products Diabetic Tussin Nighttime Cold and Flu 1 BOTTLE in 1 CARTON (61787-452-08) > 237 mL in 1 BOTTLE

325 mg/5mL, 10 mg/5mL, 12.5 mg/5mL

Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl

61787-452

Health Care Products Diabetic Tussin DM 1 BOTTLE in 1 BOX (61787-062-04) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL Dextromethorphan hydrobromide and Guaifenesin

61787-062

Health Care Products Diabetic Tussin DM Maximum Strength 1 BOTTLE in 1 BOX (61787-064-04) > 118 mL in 1 BOTTLE


61787-064

DOH 690-292 May 2016 137 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHealth Care Products Diabetic Tussin DM Maximum Strength 1 BOTTLE in 1 BOX (61787-064-08)

> 237 mL in 1 BOTTLE10 mg/5mL, 200 mg/5mL Dextromethorphan


Health Mart adult severe congestion and cough 177 mL in 1 BOTTLE (62011-0194-1) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


62011-0194

Health Mart Childrens mucus relief multi-symptom cold 1 BOTTLE in 1 CARTON (62011-0195-1) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


62011-0195

HealthLife of USA NightTime Cold and Flu Relief 16 CAPSULE, LIQUID FILLED in 1 BOTTLE (69517-103-16)

325 mg/1, 10 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan, Doxylamine

69517-103

HealthLife of USA DayTime Cold and Flu Relief 16 CAPSULE, LIQUID FILLED in 1 BOTTLE (69517-102-16)

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan, Phenylephrine

69517-102

Healthy Accents (DZA Brands, LLC) Severe Cold and Cough Relief 245 mL in 1 BOTTLE, PLASTIC (55316-316-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL


55316-316

Healthy Accents (DZA Brands, LLC) Childrens Mucus Relief 1 BOTTLE, PLASTIC in 1 BOX (55316-294-04) > 118 mL in 1 BOTTLE,PLASTIC


55316-294

HEB Mucus Relief Cold, Flu and Sore Throat 2 BLISTER PACK in 1 CARTON (37808-164-02) > 10 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37808-164

DOH 690-292 May 2016 138 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHEB Mucus Relief Severe Cold 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37808-079

HEB HEB DayTime Flu And Severe Cold And Cough 6 POWDER, FOR SOLUTION in 1 CARTON (37808-539-07)

650 mg/1, 20 mg/1, 10 mg/1


37808-539

HEB Mixed Berry Sore Throat and Cough Lozenges 18 LOZENGE in 1 CARTON (37808-062-18)

7.5 mg/1, 5 mg/1 Benzocaine 37808-062

Hi-Tech Pharmacal Co., Inc. Dextromethorphan HBr and Guaifenesin 4 TRAY in 1 CASE (50383-062-06) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-05) > 5 mL in 1 CUP, UNIT-DOSE


50383-062

Hi-Tech Pharmacal Co., Inc. Dextromethorphan HBr and Guaifenesin 10 TRAY in 1 CASE (50383-062-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE


50383-062

Hi-Tech Pharmacal Co., Inc. Dextromethorphan HBr and Guaifenesin 4 TRAY in 1 CASE (50383-062-11) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-10) > 10 mL in 1 CUP, UNIT-DOSE


50383-062

Hi-Tech Pharmacal Co., Inc. Dextromethorphan HBr and Guaifenesin 10 TRAY in 1 CASE (50383-062-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE


50383-062

Humanwell PuraCap Pharmaceutical Maximum Strength-Cough and Chest Congestion DM 1 BAG in 1 BOX (53345-034-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

10 mg/1, 200 mg/1 Maximum Strength-Cough and Chest Congestion DM

53345-034

DOH 690-292 May 2016 139 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHumanwell PuraCap Pharmaceutical Nighttime Cold and Flu 1 BAG in 1 BOX (53345-006-01) >

4000 CAPSULE, LIQUID FILLED in 1 BAG

325 mg/1, 15 mg/1, 6.25 mg/1


53345-006

Humanwell PuraCap Pharmaceutical Nighttime Cold and Flu 1 BAG in 1 BOX (53345-026-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

325 mg/1, 15 mg/1, 6.25 mg/1


53345-026

Humanwell PuraCap Pharmaceutical Night Cold Flu Cough and Allergy 1 BAG in 1 BOX (53345-020-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


53345-020

Humanwell PuraCap Pharmaceutical Daytime Severe Cold and Flu 1 BAG in 1 BOX (53345-021-01) > 3000 CAPSULE, LIQUID FILLED in 1 BAG

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1

acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride

53345-021

Humanwell PuraCap Pharmaceutical DayTime Cold and Flu 1 BAG in 1 BOX (53345-025-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

325 mg/1, 10 mg/1, 5 mg/1 acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

53345-025

Humanwell PuraCap Pharmaceutical DayTime Cold and Flu 1 BAG in 1 BOX (53345-004-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

325 mg/1, 10 mg/1, 5 mg/1 acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

53345-004

Humanwell PuraCap Pharmaceutical Dextromethorphan HBr 15 mg 1 BAG in 1 BOX (53345-011-01) > 12000 CAPSULE, LIQUID FILLED in 1 BAG


DOH 690-292 May 2016 140 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHumanwell PuraCap PharmaceuticalsDextromethorphan HBr 15 mg 1 BAG in 1 BOX (53345-028-01) >



Hy-Vee Severe Cold and Cough Relief 245 mL in 1 BOTTLE, PLASTIC (42507-316-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL


42507-316

Hy-Vee Cough Relief Grape 1 BOTTLE, PLASTIC in 1 BOX (42507-308-04) > 118 mL in 1 BOTTLE,PLASTIC


Hy-Vee Mucus Relief Cold Flu and Sore Throat 177 mL in 1 BOTTLE, PLASTIC (42507-336-06)



42507-336

Hy-Vee Mucus Relief Maximum Strength 177 mL in 1 BOTTLE, PLASTIC (42507-338-06)


42507-338

Hy-Vee Mucus Relief DM 177 mL in 1 BOTTLE, PLASTIC (42507-505-06)


42507-505

HyVee Inc Multi Symptom Cold Plus 1 BOTTLE in 1 CARTON (42507-903-26) > 118 mL in 1 BOTTLE



42507-903

HyVee Inc cold 2 BLISTER PACK in 1 CARTON (42507-014-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


42507-014

DOH 690-292 May 2016 141 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc multi symptom fever and cold 1 BOTTLE in 1 CARTON (42507-314-



42507-314

HyVee Inc cold 2 BLISTER PACK in 1 CARTON (42507-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


42507-393

HyVee Inc cough and sore throat 1 BOTTLE in 1 CARTON (42507-196-26) > 118 mL in 1 BOTTLE


42507-196

HyVee Inc cough and sore throat 1 BOTTLE in 1 CARTON (42507-023-26) > 118 mL in 1 BOTTLE


42507-023

HyVee Inc Nighttime 177 mL in 1 BOTTLE (42507-908-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


42507-908



42507-908



42507-908

HyVee Inc night time 355 mL in 1 BOTTLE (42507-872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


42507-872

HyVee Inc cough and sore throat 237 mL in 1 BOTTLE (42507-666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


42507-666

DOH 690-292 May 2016 142 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc night time 1 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


42507-977

HyVee Inc night time 2 BLISTER PACK in 1 CARTON (42507-977-60) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


42507-977


325 mg/1, 15 mg/1, 6.25 mg/1


42507-977


325 mg/1, 15 mg/1, 6.25 mg/1


42507-977

HyVee Inc Nighttime Cold and Flu 296 mL in 1 BOTTLE (42507-990-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


42507-990

HyVee Inc Cold and Flu 12 BLISTER PACK in 1 CARTON (42507-998-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


42507-998

HyVee Inc Cold and Flu 8 BLISTER PACK in 1 CARTON (42507-998-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


42507-998

HyVee Inc cold and flu 355 mL in 1 BOTTLE (42507-025-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


42507-025

DOH 690-292 May 2016 143 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc Nighttime Cold and Flu 177 mL in 1 BOTTLE (42507-041-30) 500 mg/15mL, 15


42507-041



42507-041



42507-041

HyVee Inc Cold and Flu 12 BLISTER PACK in 1 CARTON (42507-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


42507-056

HyVee Inc Cold and Flu 8 BLISTER PACK in 1 CARTON (42507-056-73) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


42507-056

HyVee Inc night time cold and flu 177 mL in 1 BOTTLE (42507-335-30) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


42507-335



42507-335



42507-335

DOH 690-292 May 2016 144 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc night time cold and flu 355 mL in 1 BOTTLE (42507-335-40) 650 mg/30mL, 30


42507-335

HyVee Inc Cold and Flu 237 mL in 1 BOTTLE (42507-401-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


42507-401

HyVee Inc Cold and Flu 355 mL in 1 BOTTLE (42507-401-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


42507-401

HyVee Inc cold and cough 240 mL in 1 BOTTLE (42507-373-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


42507-373



42507-459



42507-459



42507-459



42507-459

HyVee Inc cold and flu 237 mL in 1 BOTTLE (42507-001-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


42507-001

DOH 690-292 May 2016 145 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc cold and flu 355 mL in 1 BOTTLE (42507-001-40) 650 mg/30mL, 30


42507-001

HyVee Inc severe sinus congestion 10 BLISTER PACK in 1 CARTON (42507-345-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


42507-345

HyVee Inc Severe Cold and Flu 12 BLISTER PACK in 1 CARTON (42507-419-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


42507-419

HyVee Inc Severe Cold and Flu 237 mL in 1 BOTTLE (42507-020-34) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


42507-020



42507-020



42507-763



42507-763

DOH 690-292 May 2016 146 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc cold multi symptom 240 mL in 1 BOTTLE (42507-920-34) 325 mg/15mL, 10

mg/15mL, 6.25 mg/15mL, 5 mg/15mL


42507-920

HyVee Inc Nighttime D Cold and Flu 295 mL in 1 BOTTLE (42507-609-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL


42507-609

HyVee Inc Severe Cold and Flu 237 mL in 1 BOTTLE (42507-603-34) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


42507-603

HyVee Inc Severe Cold and Flu 355 mL in 1 BOTTLE (42507-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


42507-603

HyVee Inc Mucus Relief 2 BLISTER PACK in 1 CARTON (42507-922-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


42507-922

HyVee Inc mucus relief 10 BLISTER PACK in 1 CARTON (42507-705-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


42507-705

HyVee Inc cold 2 BLISTER PACK in 1 CARTON (42507-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


42507-234

DOH 690-292 May 2016 147 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc severe cold and flu 12 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


42507-251

HyVee Inc Mucus Relief 10 BLISTER PACK in 1 CARTON (42507-381-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


42507-381


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


42507-548


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


42507-548

HyVee Inc pain relief cold 2 BLISTER PACK in 1 CARTON (42507-371-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


42507-371

HyVee Inc Cold and Flu 177 mL in 1 BOTTLE (42507-522-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


42507-522



42507-522



42507-522

DOH 690-292 May 2016 148 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc Cold and Flu 355 mL in 1 BOTTLE (42507-522-40) 325 mg/15mL, 10


42507-522

HyVee Inc Pain Relief Cold 2 BLISTER PACK in 1 CARTON (42507-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


42507-402

HyVee Inc day time 2 BLISTER PACK in 1 CARTON (42507-215-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


42507-215



42507-215

HyVee Inc Severe Cold Cough and Flu 6 POWDER, FOR SOLUTION in 1 CARTON (42507-096-91)

650 mg/1, 20 mg/1, 10 mg/1


42507-096

HyVee Inc cold and flu 12 BLISTER PACK in 1 CARTON (42507-700-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


42507-700

HyVee Inc cold and flu 8 BLISTER PACK in 1 CARTON (42507-700-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


42507-700

HyVee Inc day time 177 mL in 1 BOTTLE (42507-656-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


42507-656

DOH 690-292 May 2016 149 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc day time 237 mL in 1 BOTTLE (42507-656-34) 325 mg/15mL, 10


42507-656



42507-656



42507-656



42507-994



42507-994



42507-994

HyVee Inc day time 2 BLISTER PACK in 1 CAPSULE (42507-994-73) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


42507-994

HyVee Inc Childrens Cold and Cough 1 BOTTLE in 1 CARTON (42507-987-26) > 118 mL in 1 BOTTLE

2 mg/10mL, 10 mg/10mL, 5 mg/10mL


42507-987

HyVee Inc Tussin Cough 1 BOTTLE in 1 CARTON (42507-300-26) > 118 mL in 1 BOTTLE


42507-300

HyVee Inc cough dm 1 BOTTLE in 1 CARTON (42507-384-21) > 89 mL in 1 BOTTLE


DOH 690-292 May 2016 150 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc cough dm 1 BOTTLE in 1 CARTON (42507-384-


HyVee Inc day time 296 mL in 1 BOTTLE (42507-473-38) 15 mg/15mL Dextromethorphan HBr 42507-473

HyVee Inc day time 355 mL in 1 BOTTLE (42507-473-40) 15 mg/15mL Dextromethorphan HBr 42507-473



HyVee Inc Cough 355 mL in 1 BOTTLE (42507-500-40) 15 mg/15mL Dextromethorphan HBr 42507-500

HyVee Inc Cough DM 1 BOTTLE in 1 CARTON (42507-958-21) > 89 mL in 1 BOTTLE


HyVee Inc Cough DM 1 BOTTLE in 1 CARTON (42507-958-28) > 148 mL in 1 BOTTLE




HyVee Inc cough 237 mL in 1 BOTTLE (42507-800-34) 30 mg/30mL, 12.5 mg/30mL


42507-800

HyVee Inc Nighttime Cough 177 mL in 1 BOTTLE (42507-668-30) 30 mg/30mL, 12.5 mg/30mL


42507-668



42507-668



42507-668

HyVee Inc tussin dm 1 BOTTLE in 1 CARTON (42507-578-26) > 118 mL in 1 BOTTLE


42507-578

DOH 690-292 May 2016 151 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCHyVee Inc Tussin DM 1 BOTTLE in 1 CARTON (42507-359-



HyVee Inc Tussin DM 1 BOTTLE in 1 CARTON (42507-359-34) > 237 mL in 1 BOTTLE


42507-359

HyVee Inc tussin dm max 1 BOTTLE in 1 CARTON (42507-799-26) > 118 mL in 1 BOTTLE


42507-799

HyVee Inc tussin dm max 1 BOTTLE in 1 CARTON (42507-799-34) > 237 mL in 1 BOTTLE


42507-799

HyVee Inc Childrens mucus relief 1 BOTTLE in 1 CARTON (42507-839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


42507-839

HyVee Inc tussin 1 BOTTLE in 1 CARTON (42507-444-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


42507-444


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


42507-444

HyVee Inc Tussin CF 1 BOTTLE in 1 CARTON (42507-516-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


42507-516

HyVee Inc Tussin CF 1 BOTTLE in 1 CARTON (42507-516-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


42507-516


20 mg/10mL, 400 mg/10mL, 10 mg/10mL


42507-296


20 mg/10mL, 400 mg/10mL, 10 mg/10mL


42507-296

DOH 690-292 May 2016 152 of 379


Infirst Healthcare Dr. Cocoa 1 BOTTLE in 1 CARTON (62372-700-04) > 120 mL in 1 BOTTLE

7.5 mg/5mL Dextromethorphan Hydrobromide

62372-700

Infirst Healthcare Dr. Cocoa Daytime Cough and Cold 1 BOTTLE in 1 CARTON (62372-721-04) > 120 mL in 1 BOTTLE

5 mg/5mL, 2.5 mg/5mL Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

62372-721

Insight Pharmaceuticals Sucrets Cough 18 LOZENGE in 1 BOX (63736-566-18)

10 mg/1 Dextromethorphan Hydrobromide

63736-566

Insight Pharmaceuticals LLC Sucrets Cough 6 LOZENGE in 1 BOX (63736-520-06)


63736-520



63736-520



63736-520

Internatiional Ethical Labs Despec-DM Tabs 100 TABLET in 1 BOTTLE (11584-1101-1)

200 mg/1, 30 mg/1, 10 mg/1

Dextromethorphan Hydrobomide, Guaifenesin, Pseudoephedrine Hydrochloride

11584-1101

International Ethical Laboratories, In DESPEC 120 mL in 1 BOTTLE (11584-1046-4) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


11584-1046

International Ethical Laboratories, In DESPEC 6 BOTTLE in 1 CARTON (11584-1046-5) > 15 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


11584-1046

International Ethical Labs Despec 30 mL in 1 BOTTLE (11584-1110-1) 5 mg/mL, 50 mg/mL, 2.5 mg/mL


11584-1110

I

DOH 690-292 May 2016 153 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCIriSys, LLC Scot-Tussin DM Maximum Strength Cough Suppressant

and Cold Relief1 BOTTLE in 1 CARTON (15187-036-04) > 118 mL in 1 BOTTLE

2 mg/5mL, 15 mg/5mL chlorpheniramine maleate and dextromethorphan hydrobromide

15187-036

IriSys, LLC Scot-Tussin Diabetes Cough Formula with DM 1 BOTTLE in 1 CARTON (15187-043-04) > 118 mL in 1 BOTTLE

10 mg/5mL dextromethorphan hydrobromide

15187-043

IriSys, LLC Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant



15187-050

J.P. BUSINESS ENTERPRISE ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE


325 mg/1, 15 mg/1, 6.25 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE

59105-005

J.P. BUSINESS ENTERPRISE ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE


325 mg/1, 5 mg/1, 10 mg/1 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE

59105-004

J.P. BUSINESS ENTERPRISE DEXTROMETHORPHAN HYDROBROMIDE 1 BOTTLE in 1 CARTON (59105-006-15) > 15 CAPSULE, LIQUID FILLED in1 BOTTLE

15 mg/1 DEXTROMETHORPHAN HYDROBROMIDE

59105-006

JC World Bell Wholesale Co., Inc. Vicks NyQuil 25 PACKET in 1 BOX (50269-557-25) > 2 CAPSULE, LIQUID FILLED in 1PACKET

325 mg/1, 15 mg/1, 6.25 mg/1


50269-557

J

DOH 690-292 May 2016 154 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCJC World Bell Wholesale Co., Inc. Vicks DayQuil 25 PACKET in 1 BOX (50269-811-25)

> 2 TABLET in 1 PACKET325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


50269-811

Johnson & Johnson Consumer Inc., MTYLENOL COLD 240 mL in 1 BOTTLE, PLASTIC (50580-269-08)


Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride

50580-269

Johnson & Johnson Consumer Inc., MTYLENOL COLD MAX 240 mL in 1 BOTTLE, PLASTIC (50580-571-01)



50580-571

Johnson & Johnson Consumer Inc., MTYLENOL Cold 240 mL in 1 BOTTLE, PLASTIC (50580-351-08)


Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine hydrochloride

50580-351

Johnson & Johnson Consumer Inc., MTYLENOL Cold Plus Flu 2 BLISTER PACK in 1 CARTON (50580-402-26) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


50580-402

DOH 690-292 May 2016 155 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCJohnson & Johnson Consumer Inc., MTYLENOL Cold Plus Flu 3 CARTON in 1 PACKAGE (50580-

402-72) > 2 BLISTER PACK in 1CARTON (50580-402-26) > 12TABLET, FILM COATED in 1 BLISTERPACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


50580-402

Johnson & Johnson Consumer Inc., MTYLENOL COLD PLUS FLU SEVERE 240 mL in 1 BOTTLE, PLASTIC (50580-403-08)


Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

50580-403

Johnson & Johnson Consumer Inc., MTYLENOL Cold Plus Mucus Severe 240 mL in 1 BOTTLE, PLASTIC (50580-511-01)


Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine hydrochloride

50580-511

Johnson & Johnson Consumer Inc., MSudafed PE Pressure Plus Pain Plus Cold 2 BLISTER PACK in 1 CARTON (50580-679-25) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


50580-679

Johnson & Johnson Consumer Inc., MTYLENOL COLD MULTI-SYMPTOM DAYTIME 240 mL in 1 BOTTLE, PLASTIC (50580-257-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride

50580-257

Johnson & Johnson Consumer Inc., MTYLENOL COLD MAX 2 BLISTER PACK in 1 CARTON (50580-515-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride

50580-515

DOH 690-292 May 2016 156 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCJohnson & Johnson Consumer Inc., MTYLENOL COLD MAX 240 mL in 1 BOTTLE, PLASTIC

(50580-525-01)325 mg/15mL, 10 mg/15mL, 5 mg/15mL


50580-525

Johnson & Johnson Consumer Inc., MSudafed PE Pressure plus Pain plus Cough 2 BLISTER PACK in 1 CARTON (50580-550-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK


50580-550

Johnson & Johnson Consumer Inc., MTYLENOL Cold Multi-Symptom Daytime 2 BLISTER PACK in 1 CARTON (50580-406-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride

50580-406

Johnson & Johnson Consumer Inc., MChildrens SUDAFED PE Cold plus Cough 1 BOTTLE in 1 CARTON (50580-785-04) > 118 mL in 1 BOTTLE

5 mg/5mL, 2.5 mg/5mL Dextromethorphan hydrobromide and Phenylephrine hydrochloride

50580-785

JW Holdings Facol Cold and Flu Day 1 BLISTER PACK in 1 KIT (69365-001-02) > 1 CAPSULE, LIQUID FILLED in 1BLISTER PACK

200 mg/1, 35 mg/1, 8 mg/1, 5 mg/1

acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide

69365-001

JW HOLDINGS Facol Cold and Flu Night 1 BLISTER PACK in 1 CARTON (69365-003-02) > 1 CAPSULE in 1 BLISTER PACK > 10 CAPSULE, LIQUID FILLED in 1 CAPSULE

200 mg/1, 35 mg/1, 5 mg/1, 8 mg/1, 18.75 mg/1

acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl

69365-003

JW HOLDINGS Facol Cold and Flu Day and Night 1 BLISTER PACK in 1 CARTON (69365-004-01) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

18.75 mg/1, 8 mg/1, 5 mg/1, 35 mg/1, 200 mg/1

acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue

69365-004

DOH 690-292 May 2016 157 of 379


Kareway Product, Inc. Night Time Cold/Flu Relief Original 295 mL in 1 BOTTLE (67510-1501-0) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


67510-1501



67510-1501



67510-1501



67510-1501

Kareway Product, Inc. Night Time Cold/Flu Relief Cherry 295 mL in 1 BOTTLE (67510-1507-0) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


67510-1507



67510-1507



67510-1507



67510-1507



67510-1561

K

DOH 690-292 May 2016 158 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKareway Product, Inc. Night Time Cold/Flu Relief Original 295 mL in 1 BOTTLE (67510-1562-1) 650 mg/30mL, 30


67510-1562



67510-0501



67510-0501



67510-0501



67510-0501



67510-0507



67510-0507



67510-0507



67510-0507

DOH 690-292 May 2016 159 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKareway Product, Inc. Night Time Gelcap 2 BLISTER PACK in 1 BOX (67510-


325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan, Doxylamine

67510-0521

Kareway Product, Inc. Night Time Gelcap 1 BLISTER PACK in 1 BOX (67510-0521-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


67510-0521



67510-0521



67510-0521

Kareway Product, Inc. Day Time Gelcap 2 BLISTER PACK in 1 BOX (67510-0523-0) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


67510-0523



67510-0523



67510-0523



67510-0523

Kareway Product, Inc. Day Time Cold/Flu Relief 295 mL in 1 BOTTLE (67510-0544-0) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan, Phenylephrine

67510-0544

DOH 690-292 May 2016 160 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKareway Product, Inc. Day Time Cold/Flu Relief 354 mL in 1 BOTTLE (67510-0544-2) 325 mg/15mL, 10

mg/15mL, 5 mg/15mLAcetaminophen, Dextromethorphan, Phenylephrine

67510-0544



67510-0544



67510-0544

Kareway Product, Inc. Night Time Cough 295 mL in 1 BOTTLE (67510-0503-1) 15 mg/15mL, 6.25 mg/15mL


67510-0503



67510-0503



67510-0503



67510-0503

Kareway Product, Inc. Tussin DM 1 BOTTLE in 1 BOX (67510-0527-4) > 120 mL in 1 BOTTLE


67510-0527

Kareway Product, Inc. Tussin CF 1 BOTTLE in 1 BOX (67510-0506-4) > 120 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


67510-0506

Kinray Preferred Plus Severe Nite Time 237 mL in 1 BOTTLE (61715-111-08) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


61715-111

DOH 690-292 May 2016 161 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKinray Preferred Plus Severe Sinus Congestion 10 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


61715-141

Kinray preferred plus mucus relief 10 BLISTER PACK in 1 CARTON (61715-146-20) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


61715-146

Kinray preferred plus severe cold 10 BLISTER PACK in 1 CARTON (61715-147-20) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


61715-147

Kinray Preferred Plus Severe Day Time 237 mL in 1 BOTTLE (61715-112-08) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


61715-112

Kinray Preferred Plus Day Time Cold and Flu 6 BLISTER PACK in 1 CARTON (61715-106-12) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


61715-106

Kinray Preferred Plus Severe Cold Cough and Flu 6 POWDER, FOR SOLUTION in 1 CARTON (61715-120-06)

650 mg/1, 20 mg/1, 10 mg/1


61715-120

Kinray Tussin Cough Long Acting 118 mL in 1 BOTTLE, PLASTIC (63777-098-04)


63777-098

Kinray preferred plus cough dm 1 BOTTLE in 1 CARTON (61715-113-03) > 89 mL in 1 BOTTLE


DOH 690-292 May 2016 162 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKinray Preferred Plus Intense Cough Reliever 1 BOTTLE, PLASTIC in 1 CARTON

(61715-077-04) > 120 mL in 1 BOTTLE, PLASTIC


61715-077

Kinray Preferred Plus Chest Congestion Relief DMTDM 1 TABLET in 1 CARTON (61715-013-01)


61715-013

Kinray Preferred Plus Chest Congestion Relief DMTDM 50 TABLET in 1 BOTTLE, PLASTIC (61715-013-50)


61715-013

Kinray Preferred Plus TabTussin DM 2 BLISTER PACK in 1 CARTON (61715-066-24) > 12 TABLET in 1 BLISTER PACK


61715-066

Kinray preferred plus childrens mucus relief multi symptom cold


5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


61715-138

Kinray LLC Cough and Sore Throat Daytime 236 mL in 1 BOTTLE (61715-076-08) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

61715-076

Kinray LLC Cough and Sore Throat Nighttime 236 mL in 1 BOTTLE (61715-075-08) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


61715-075

Kinray LLC Cough Multi Symptom 236 mL in 1 BOTTLE (61715-074-08) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 5 mg/15mL


61715-074

Kinray, Inc Childrens Plus Cough and Runny Nose 118 mL in 1 BOTTLE, PLASTIC (63777-130-04)


Acetaminophen, Chlorpheniramine Maleate, DEXTROMETHORPHAN HYDROBROMIDE

63777-130

DOH 690-292 May 2016 163 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKinray, Inc Childrens Plus Multi-Symptom 118 mL in 1 BOTTLE, PLASTIC


Acetominophen, Chlorphenramine Maleate, Dextrmethrophan Hydrobromide

63777-145

Kmart Corporation smart sense multi symptom cold 1 BOTTLE in 1 CARTON (49738-903-26) > 118 mL in 1 BOTTLE



49738-903

Kmart Corporation Smart Sense Childrens Multi Symptom Cold Relief 1 BOTTLE in 1 CARTON (49738-846-26) > 118 mL in 1 BOTTLE



49738-846

Kmart Corporation smart sense multi symptom fever and cold 1 BOTTLE in 1 CARTON (49738-011-26) > 118 mL in 1 BOTTLE



49738-011

Kmart Corporation smart sense nighttime 296 mL in 1 BOTTLE (49738-041-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49738-041



49738-041



49738-335

DOH 690-292 May 2016 164 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKmart Corporation smart sense nighttime 354 mL in 1 BOTTLE (49738-335-40) 650 mg/30mL, 30


49738-335



49738-459



49738-459



49738-459


- acetaminophen,dextromethorphanhydrobromide and doxylaminesuccinate liquid

49738-990

Kmart Corporation Smart Sense NightTime Cold and Flu 354 mL in 1 BOTTLE (49738-872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49738-872

Kmart Corporation smart sense nighttime cold and flu relief 296 mL in 1 BOTTLE (49738-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49738-908

Kmart Corporation Smart Sense nighttime cold and flu 12 BLISTER PACK in 1 CARTON (49738-507-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


49738-507

DOH 690-292 May 2016 165 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKmart Corporation Smart Sense Severe Cold and Flu NightTime 354 mL in 1 BOTTLE (49738-763-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


49738-763

Kmart Corporation Smart Sense cold flu and sore throat 10 BLISTER PACK in 1 CARTON (49738-381-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49738-381

Kmart Corporation KMart - Fast Maximum Cold, Flu and Sore Throat Relief 180 mL in 1 BOTTLE (49738-995-18) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


49738-995

Kmart Corporation Smart Sense DayTime 354 mL in 1 BOTTLE (49738-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


49738-603

Kmart Corporation Smart Sense daytime cold and flu 12 BLISTER PACK in 1 CARTON (49738-548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49738-548

Kmart Corporation Smart Sense Severe Cold 10 BLISTER PACK in 1 CARTON (49738-922-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49738-922

Kmart Corporation smart sense daytime 296 mL in 1 BOTTLE (49738-656-38) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49738-656

DOH 690-292 May 2016 166 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKmart Corporation smart sense daytime 354 mL in 1 BOTTLE (49738-656-40) 325 mg/15mL, 10


49738-656

Kmart Corporation smart sense flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (49738-096-91)

650 mg/1, 20 mg/1, 10 mg/1


49738-096

Kmart Corporation smart sense cold and cough 1 BOTTLE in 1 CARTON (49738-987-34) > 237 mL in 1 BOTTLE



49738-987

Kmart Corporation Smart Sense Cough DM 1 BOTTLE in 1 CARTON (49738-958-21) > 89 mL in 1 BOTTLE






Kmart Corporation smart sense nighttime cough 296 mL in 1 BOTTLE (49738-668-38) 30 mg/30mL, 12.5 mg/30mL


49738-668

Kmart Corporation smart sense nighttime cough 354 mL in 1 BOTTLE (49738-668-40) 30 mg/30mL, 12.5 mg/30mL


49738-668

Kmart Corporation smart sense tussin dm 1 BOTTLE in 1 CARTON (49738-359-26) > 118 mL in 1 BOTTLE


49738-359

Kmart Corporation smart sense tussin dm 1 BOTTLE in 1 CARTON (49738-359-34) > 237 mL in 1 BOTTLE


49738-359

Kmart Corporation Smart Sense Mucus Relief Cough 1 BOTTLE in 1 CARTON (49738-419-26) > 118 mL in 1 BOTTLE


49738-419

DOH 690-292 May 2016 167 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKmart Corporation smart sense cough and chest congestion 1 BOTTLE in 1 CARTON (49738-143-



Kmart Corporation smart sense cough and chest congestion 1 BOTTLE in 1 CARTON (49738-143-34) > 237 mL in 1 BOTTLE


49738-143

Kmart Corporation Smart Sense tussin dm max 1 BOTTLE in 1 CARTON (49738-799-26) > 118 mL in 1 BOTTLE


49738-799

Kmart Corporation Smart Sense Adult Tussin DM 1 BOTTLE in 1 CARTON (49738-578-34) > 237 mL in 1 BOTTLE


49738-578

Kmart Corporation smart sense cough and chest congestion 1 BOTTLE in 1 CARTON (49738-522-26) > 118 mL in 1 BOTTLE


49738-522

Kmart Corporation KMart - Fast Maximum DM MAX 180 mL in 1 BOTTLE (49738-998-18) 20 mg/20mL, 400 mg/20mL Dextromethorphan Hydrobromide and Guaifenesin

49738-998

Kmart Corporation smart sense tussin cf 1 BOTTLE in 1 CARTON (49738-516-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


49738-516

Kmart Corporation smart sense tussin cf 1 BOTTLE in 1 CARTON (49738-516-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


49738-516

Kmart Corporation KMart - Fast Maximum Severe Congestion and Cough 177 mL in 1 BOTTLE (49738-997-24) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


49738-997


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49738-280


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49738-280

DOH 690-292 May 2016 168 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKmart Corporation smart sense adults tussin cf 1 BOTTLE in 1 CARTON (49738-301-



49738-301

Kmart Corporation smart sense adults tussin cf 1 BOTTLE in 1 CARTON (49738-301-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49738-301

Kramer Laboratories Safetussin 240 mL in 1 BOTTLE, PLASTIC (55505-190-36)

7.5 mg/5mL, 3.125 mg/5mL Dextromethorphan Doxylamine Succinate

55505-190


10 mg/5mL, 100 mg/5mL Dextromethorpan Guaifenesin 55505-189


10 mg/5mL, 100 mg/5mL Dextromethorpan Guaifenesin 55505-111


7.5 mg/5mL, 3.125 mg/5mL Dextromethorphan Doxylamine Succinate

55505-173

KRAMER NOVIS GENCONTUSS 473 mL in 1 BOTTLE, PLASTIC (52083-650-16)



52083-650

Kramer Novis G-P-TUSS DXP 473 mL in 1 BOTTLE (52083-602-16) 2 mg/5mL, 20 mg/5mL, 10 mg/5mL

dexbrompheniramine, dextromethorphan, and phenylephrine

52083-602

Kramer Novis SUPRESS A 30 mL in 1 BOTTLE, PLASTIC (52083-057-01)

1 mg/mL, 10 mg/mL, 5 mg/mL

Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl

52083-057

DOH 690-292 May 2016 169 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKramer Novis ABATUSS DMX 1 BOTTLE in 1 CARTON (52083-625-


DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

52083-625

KRAMER NOVIS Presgen B 480 mL in 1 BOTTLE (52083-637-16) 20 mg/5mL, 4 mg/5mL, 10 mg/5mL

dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride

52083-637

KRAMER NOVIS Tussi Pres B 30 mL in 1 BOTTLE (52083-237-01) 20 mg/5mL, 4 mg/5mL, 10 mg/5mL


52083-237



52083-237



52083-237

Kramer Novis ZYNCOF 30 mL in 1 BOTTLE, PLASTIC (52083-400-01)


52083-400



52083-400



52083-400

DOH 690-292 May 2016 170 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKRAMER NOVIS ZYNCOF 2 TABLET in 1 PACKET (52083-410-

02)20 mg/1, 400 mg/1 Dextromethorphan

Hydrobromide, Guaifenesin52083-410

KRAMER NOVIS ZYNCOF 60 TABLET in 1 BOTTLE, PLASTIC (52083-410-60)

20 mg/1, 400 mg/1 Dextromethorphan Hydrobromide, Guaifenesin

52083-410

Kramer Novis G-ZYNCOF 473 mL in 1 BOTTLE, PLASTIC (52083-600-16)


52083-600

KRAMER NOVIS PECGEN DMX 474 mL in 1 BOTTLE, PLASTIC (52083-630-16)


52083-630

KRAMER NOVIS Sorbugen 480 mL in 1 BOTTLE (52083-660-16) 15 mg/7.5mL, 150 mg/7.5mL

dextromethorphan hydrobromide, glycerol guaiacolate

52083-660

Kramer Novis G-TRON 474 mL in 1 BOTTLE (52083-678-16) 15 mg/5mL, 350 mg/5mL, 10 mg/5mL

Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl

52083-678

KRAMER NOVIS G-TRON PEDIATRIC DROPS 30 mL in 1 BOTTLE, DROPPER (52083-679-01)

5 mg/mL, 100 mg/mL, 2.5 mg/mL

Dextromethorphan HBr,Guaifenesin,Phenylephrine HCL

52083-679

Kramer Novis G-TUSICOF 474 mL in 1 BOTTLE (52083-639-16) 20 mg/5mL, 400 mg/5mL, 10 mg/5mL

dextromethorphan, guaifenesin, and phenylephrine

52083-639

Kramer Novis Desgen 30 mL in 1 BOTTLE, DROPPER (52083-641-01)



52083-641

KRAMER NOVIS Desgen DM 480 mL in 1 BOTTLE (52083-645-16) 15 mg/5mL, 100 mg/5mL, 5 mg/5mL


52083-645

Kramer Novis DESGEN DM 474 mL in 1 BOTTLE (52083-646-16) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL

Dextromethorphan HBr ,Guaifenesin ,Phenylephrine HCl

52083-646

DOH 690-292 May 2016 171 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKramer Novis TUSICOF 30 mL in 1 BOTTLE (52083-239-01) 20 mg/5mL, 400 mg/5mL,

10 mg/5mLdextromethorphan, guaifenesin, and phenylephrine

52083-239

Kramer Novis TUSICOF 120 mL in 1 BOTTLE (52083-239-04) 20 mg/5mL, 400 mg/5mL, 10 mg/5mL


52083-239

Kramer Novis TUSICOF 474 mL in 1 BOTTLE (52083-239-16) 20 mg/5mL, 400 mg/5mL, 10 mg/5mL


52083-239

Kramer Novis Tusslin 474 mL in 1 BOTTLE (52083-622-16) 28 mg/5mL, 388 mg/5mL, 10 mg/5mL


52083-622

Kramer Novis Tusslin 30 mL in 1 BOTTLE, DROPPER (52083-623-01)

7.5 mg/mL, 88 mg/mL, 2.5 mg/mL


52083-623

KRAMER NOVIS Tusslin TR 100 TABLET in 1 BOTTLE (52083-617-10)

28 1/1, 388 1/1, 10 1/1 dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

52083-617

Kramer Novis PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor



52083-628

KRAMER NOVIS DESGEN DM Tabs 100 TABLET in 1 BOTTLE, PLASTIC (52083-648-10)

10 mg/1, 200 mg/1, 30 mg/1


52083-648

DOH 690-292 May 2016 172 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKRAMER NOVIS Pecgen DMX 480 mL in 1 BOTTLE (52083-620-16) 125 mg/5mL, 15 mg/5mL guaifenesin,Dextromethorphan

hydrobromide52083-620

Kramer Novis G Tron 474 mL in 1 BOTTLE (52083-601-16) 100 mg/5mL, 10 mg/5mL Guaifenesin Dextromethorphan

52083-601

KRAMER NOVIS Supress DM 30 mL in 1 BOTTLE (52083-058-01) 50 mg/mL, 5 mg/mL dextromethorphan hydrobromide, guaifenesin

52083-058

KRAMER NOVIS Supress DX Pediatric Drops 30 mL in 1 BOTTLE (52083-055-01) 50 mg/mL, 5 mg/mL, 2.5 mg/mL


52083-055

KRAMER NOVIS G-Supress DX 30 mL in 1 BOTTLE (52083-655-01) 50 mg/mL, 5 mg/mL, 2.5 mg/mL


52083-655

Kramer Novis Tussi Pres 120 mL in 1 BOTTLE (52083-231-04) 200 mg/5mL, 5 mg/5mL, 10 mg/5mL

guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide

52083-231

Kramer Novis Tussi Pres 10 mL in 1 PACKET (52083-231-10) 200 mg/5mL, 5 mg/5mL, 10 mg/5mL


52083-231



52083-231

KRAMER NOVIS TUSSI PRES PEDIATRIC 30 mL in 1 BOTTLE (52083-232-01) 75 mg/5mL, 2.5 mg/5mL, 5 mg/5mL

GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE

52083-232

DOH 690-292 May 2016 173 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKRAMER NOVIS TUSSI PRES PEDIATRIC 120 mL in 1 BOTTLE (52083-232-04) 75 mg/5mL, 2.5 mg/5mL, 5

mg/5mLGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE

52083-232

KRAMER NOVIS TUSSI PRES PEDIATRIC 480 mL in 1 BOTTLE (52083-232-16) 75 mg/5mL, 2.5 mg/5mL, 5 mg/5mL


52083-232



52083-233



52083-233



52083-233

Kramer Novis Presgen 480 mL in 1 BOTTLE (52083-632-16) 200 mg/5mL, 5 mg/5mL, 10 mg/5mL


52083-632

KRAMER NOVIS PRESGEN PEDIATRIC 480 mL in 1 BOTTLE (52083-653-16) 75 mg/5mL, 2.5 mg/5mL, 5 mg/5mL


52083-653

DOH 690-292 May 2016 174 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKramer Novis. Guaifenesin Phenylephrine Dextromethorphan 2 TABLET, COATED in 1 PACKET

(52083-249-02)400 mg/1, 20 mg/1, 10 mg/1

Guaifenesin, phenylephrine HCL, Dextromethorphan

52083-249

Kramer Novis. Guaifenesin Phenylephrine Dextromethorphan 60 TABLET, COATED in 1 BOTTLE (52083-249-60)

400 mg/1, 20 mg/1, 10 mg/1


52083-249

Kramer Novis. Tusicof 2 TABLET, COATED in 1 PACKET (52083-289-02)

400 mg/1, 20 mg/1, 10 mg/1


52083-289

Kramer Novis. Tusicof 60 TABLET, COATED in 1 BOTTLE (52083-289-60)

400 mg/1, 20 mg/1, 10 mg/1


52083-289

Kroger Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC (30142-155-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


30142-155

Kroger Company Multi Symptom Cold 1 BOTTLE in 1 CARTON (30142-903-26) > 118 mL in 1 BOTTLE



30142-903

Kroger Company Childrens Multi Symptom Fever and Cold 1 BOTTLE in 1 CARTON (30142-023-26) > 118 mL in 1 BOTTLE



30142-023

Kroger Company childrens pain relief plus 1 BOTTLE in 1 CARTON (30142-196-26) > 118 mL in 1 BOTTLE


30142-196

Kroger Company Nite Time 295 mL in 1 BOTTLE (30142-990-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


30142-990



30142-908

DOH 690-292 May 2016 175 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company Nite Time 295 mL in 1 BOTTLE (30142-908-38) 500 mg/15mL, 15


30142-908



30142-908

Kroger Company Nite Time 4 BLISTER PACK in 1 CARTON (30142-977-58) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


30142-977


325 mg/1, 15 mg/1, 6.25 mg/1


30142-977


325 mg/1, 15 mg/1, 6.25 mg/1


30142-977


325 mg/1, 15 mg/1, 6.25 mg/1


30142-977

Kroger Company nite time 295 mL in 1 BOTTLE (30142-872-38) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


30142-872



30142-872

DOH 690-292 May 2016 176 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company Nitetime Cold and Flu 12 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


30142-758

Kroger Company Nitetime Cold and Flu 24 BLISTER PACK in 1 CARTON (30142-758-67) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


30142-758



30142-335



30142-335



30142-335



30142-335



30142-459



30142-459



30142-459

DOH 690-292 May 2016 177 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company nite time 354 mL in 1 BOTTLE (30142-459-40) 650 mg/30mL, 30


30142-459

Kroger Company Nite Time Cold and Flu Relief 177 mL in 1 BOTTLE (30142-041-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


30142-041



30142-041



30142-041

Kroger Company Nite Time 12 BLISTER PACK in 1 CARTON (30142-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


30142-056

Kroger Company Nite Time 24 BLISTER PACK in 1 CARTON (30142-056-67) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


30142-056

Kroger Company severe sinus congestion 10 BLISTER PACK in 1 CARTON (30142-345-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


30142-345

DOH 690-292 May 2016 178 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company NiteTime Severe Cold and Flu 354 mL in 1 BOTTLE (30142-763-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


30142-763

Kroger Company NiteTime 295 mL in 1 BOTTLE (30142-609-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL


30142-609

Kroger Company Mucus Relief 2 BLISTER PACK in 1 CARTON (30142-381-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-381

Kroger Company daytime severe 12 BLISTER PACK in 1 CARTON (30142-548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-548

Kroger Company cold 2 BLISTER PACK in 1 CARTON (30142-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-234

Kroger Company cold 2 BLISTER PACK in 1 CARTON (30142-308-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-308

Kroger Company daytime severe cold and flu 354 mL in 1 BOTTLE (30142-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


30142-603

DOH 690-292 May 2016 179 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company Fast Mucus Relief 10 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-888

Kroger Company Fast Mucus Relief 15 BLISTER PACK in 1 CARTON (30142-888-39) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-888

Kroger Company fast mucus relief 10 BLISTER PACK in 1 CARTON (30142-707-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-707

Kroger Company fast mucus relief 15 BLISTER PACK in 1 CARTON (30142-707-39) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-707

Kroger Company Mucus Relief 2 BLISTER PACK in 1 CARTON (30142-971-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


30142-971

Kroger Company daytime 4 BLISTER PACK in 1 CARTON (30142-994-58) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


30142-994



30142-994

DOH 690-292 May 2016 180 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company daytime 2 BLISTER PACK in 1 CARTON



30142-994



30142-994

Kroger Company daytime cold and flu 12 BLISTER PACK in 1 CARTON (30142-704-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


30142-704

Kroger Company daytime cold and flu 24 BLISTER PACK in 1 CARTON (30142-704-67) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


30142-704

Kroger Company Day Time 295 mL in 1 BOTTLE (30142-656-38) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


30142-656

Kroger Company Day Time 354 mL in 1 BOTTLE (30142-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


30142-656



30142-215



30142-215

DOH 690-292 May 2016 181 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company Kroger DayTime Flu plus Severe Cold and Cough 6 POWDER, FOR SOLUTION in 1

CARTON (30142-112-07)650 mg/1, 20 mg/1, 10 mg/1


30142-112

Kroger Company flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (30142-096-91)

650 mg/1, 20 mg/1, 10 mg/1


30142-096

Kroger Company Childrens Cold and Cough 1 BOTTLE in 1 CARTON (30142-987-26) > 118 mL in 1 BOTTLE



30142-987

Kroger Company Cough DM 1 BOTTLE in 1 CARTON (30142-384-21) > 89 mL in 1 BOTTLE


Kroger Company Cough DM 1 BOTTLE in 1 CARTON (30142-958-21) > 89 mL in 1 BOTTLE


Kroger Company NiteTime Cough 295 mL in 1 BOTTLE (30142-668-38) 30 mg/30mL, 12.5 mg/30mL


30142-668

Kroger Company NiteTime Cough 354 mL in 1 BOTTLE (30142-668-40) 30 mg/30mL, 12.5 mg/30mL


30142-668

Kroger Company Tussin DM Max 1 BOTTLE in 1 CARTON (30142-799-26) > 118 mL in 1 BOTTLE


30142-799

Kroger Company childrens mucus relief cough 1 BOTTLE in 1 CARTON (30142-419-26) > 118 mL in 1 BOTTLE


30142-419

Kroger Company Tussin 1 BOTTLE in 1 CARTON (30142-359-26) > 118 mL in 1 BOTTLE


30142-359

Kroger Company Tussin 1 BOTTLE in 1 CARTON (30142-359-34) > 236 mL in 1 BOTTLE


30142-359

DOH 690-292 May 2016 182 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCKroger Company tussin dm 1 BOTTLE in 1 CARTON (30142-578-



Kroger Company tussin cf 1 BOTTLE in 1 CARTON (30142-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


30142-516

Kroger Company tussin cf 1 BOTTLE in 1 CARTON (30142-516-34) > 236 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


30142-516

Kroger Company Childrens Mucus Relief 1 BOTTLE in 1 CARTON (30142-839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


30142-839

L Perrigo Company good sense cold 2 BLISTER PACK in 1 CARTON (0113-0014-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


0113-0014

L Perrigo Company good sense cold 2 BLISTER PACK in 1 CARTON (0113-0393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


0113-0393

L Perrigo Company good sense cough and sore throat 237 mL in 1 BOTTLE (0113-0698-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

0113-0698

L Perrigo Company good sense night time 296 mL in 1 BOTTLE (0113-0990-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0113-0990

L

DOH 690-292 May 2016 183 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL Perrigo Company Good Sense night time 6 BLISTER PACK in 1 CARTON (0113-


325 mg/1, 15 mg/1, 6.25 mg/1


0113-0977

L Perrigo Company Good Sense night time 10 BLISTER PACK in 1 CARTON (0113-0977-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


0113-0977


325 mg/1, 15 mg/1, 6.25 mg/1


0113-0977


325 mg/1, 15 mg/1, 6.25 mg/1


0113-0977

L Perrigo Company Good Sense Night Time 177 mL in 1 BOTTLE (0113-0908-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0113-0908



0113-0908

L Perrigo Company Good Sense Night Time 2 BOTTLE in 1 PACKAGE (0113-0908-40) > 177 mL in 1 BOTTLE

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0113-0908

L Perrigo Company good sense cough and sore throat 237 mL in 1 BOTTLE (0113-0666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0113-0666

DOH 690-292 May 2016 184 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL Perrigo Company Good Sense Night Time 177 mL in 1 BOTTLE (0113-0041-30) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mLacetaminophen, dextromethorphan hydrobromide, doxylamine succinate

0113-0041



0113-0041

L Perrigo Company Good Sense Severe NightTime 237 mL in 1 BOTTLE (0113-0019-34) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


0113-0019

L Perrigo Company Good Sense Severe NightTime 355 mL in 1 BOTTLE (0113-0019-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


0113-0019

L Perrigo Company good sense cold head congestion 2 BLISTER PACK in 1 CARTON (0113-0234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0234

L Perrigo Company Good Sense Cold 2 BLISTER PACK in 1 CARTON (0113-0402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


0113-0402

L Perrigo Company Good Sense cold 12 BLISTER PACK in 1 CARTON (0113-0371-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK


0113-0371

DOH 690-292 May 2016 185 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL Perrigo Company Good Sense Childrens Cold and Cough 1 BOTTLE in 1 CARTON (0113-0987-



0113-0987

L Perrigo Company good sense cough dm 1 BOTTLE in 1 CARTON (0113-0384-21) > 89 mL in 1 BOTTLE


L Perrigo Company good sense cough dm 1 BOTTLE in 1 CARTON (0113-0384-28) > 148 mL in 1 BOTTLE


L Perrigo Company Good Sense tussin 1 BOTTLE in 1 CARTON (0113-0799-26) > 118 mL in 1 BOTTLE


0113-0799

L Perrigo Company Good Sense tussin 1 BOTTLE in 1 CARTON (0113-0799-34) > 237 mL in 1 BOTTLE


0113-0799

L Perrigo Company good sense day time 296 mL in 1 BOTTLE (0113-0818-38) 10 mg/15mL, 200 mg/15mL Dextromethorphan HBr, Guaifenesin

0113-0818

L Perrigo Company good sense tussin cf 1 BOTTLE in 1 CARTON (0113-0516-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


0113-0516

L Perrigo Company good sense tussin cf 1 BOTTLE in 1 CARTON (0113-0516-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


0113-0516

L&R Distributors, Inc. Flu BP 2 BLISTER PACK in 1 CARTON (15127-958-20) > 10 TABLET, FILM COATED in 1 BLISTER PACK

500 mg/1, 2 mg/1, 15 mg/1 Acetaminophen, Chlorpheniramine maleate and Dextromethorphan HBr

15127-958

L&R Distributors, Inc. Cold and Flu 3 BLISTER PACK in 1 CARTON (15127-660-12) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


15127-660

L&R Distributors, Inc. Cold and Flu 1 BLISTER PACK in 1 CARTON (15127-985-12) > 12 CAPSULE in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


15127-985

DOH 690-292 May 2016 186 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL&R Distributors, Inc. Cold Multi-Symptom 1 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin

15127-962

L&R Distributors, Inc. Cold Head Congestion Severe 2 BLISTER PACK in 1 CARTON (15127-964-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


15127-964



15127-989



15127-659

L&R Distributors, Inc. Cold and Flu 2 BLISTER PACK in 1 CARTON (15127-503-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 5 mg/1, 200 mg/1, 10 mg/1

Acetaminophen, Phenylephrine HCl, Guaifenesin, Dextromethorphan HBr

15127-503

L&R Distributors, Inc. Cough and Cold 2 BLISTER PACK in 1 CARTON (15127-268-16) > 8 TABLET in 1 BLISTER PACK

4 mg/1, 30 mg/1 Chlorpheniramine maleate and Dextromethorphan Hydrobromide

15127-268

L&R Distributors, Inc. Cough Control 1 BOTTLE in 1 PACKAGE (15127-984-20) > 20 CAPSULE, GELATINCOATED in 1 BOTTLE


L&R Distributors, Inc. Cough Control 1 BOTTLE in 1 PACKAGE (15127-661-20) > 20 CAPSULE, LIQUID FILLED in1 BOTTLE


DOH 690-292 May 2016 187 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL. Perrigo Company good sense cold 1 BOTTLE in 1 CARTON (0113-0903-



0113-0903

L. Perrigo Company Good Sense Night Time Cold and Flu 354 mL in 1 BOTTLE (0113-0872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0113-0872

L. Perrigo Company good sense nighttime 177 mL in 1 BOTTLE (0113-0459-30) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0113-0459



0113-0459



0113-0459



0113-0459

L. Perrigo Company good sense night time 177 mL in 1 BOTTLE (0113-0335-30) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0113-0335



0113-0335



0113-0335

DOH 690-292 May 2016 188 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL. Perrigo Company good sense night time 354 mL in 1 BOTTLE (0113-0335-40) 650 mg/30mL, 30


0113-0335

L. Perrigo Company good sense night time 12 BLISTER PACK in 1 CARTON (0113-0056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


0113-0056

L. Perrigo Company good sense night time 8 BLISTER PACK in 1 CARTON (0113-0056-73) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


0113-0056

L. Perrigo Company Good Sense Severe Sinus Congestion 10 BLISTER PACK in 1 CARTON (0113-0345-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


0113-0345

L. Perrigo Company Good Sense Severe NightTime Cold and Flu 237 mL in 1 BOTTLE (0113-0763-34) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


0113-0763

L. Perrigo Company Good Sense Severe NightTime Cold and Flu 354 mL in 1 BOTTLE (0113-0763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


0113-0763

L. Perrigo Company Good Sense Mucus Relief 2 BLISTER PACK in 1 CARTON (0113-0922-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0922

DOH 690-292 May 2016 189 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL. Perrigo Company good sense severe cold 10 BLISTER PACK in 1 PACKAGE


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0579

L. Perrigo Company Good Sense Severe Daytime Cold and Flu 237 mL in 1 BOTTLE (0113-0603-34) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


0113-0603

L. Perrigo Company Good Sense Severe Daytime Cold and Flu 355 mL in 1 BOTTLE (0113-0603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


0113-0603

L. Perrigo Company Good Sense Severe Daytime 6 BLISTER PACK in 1 CARTON (0113-0548-53) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0548

L. Perrigo Company Good Sense Severe Daytime 12 BLISTER PACK in 1 CARTON (0113-0548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0548

L. Perrigo Company Good Sense Mucus Relief 10 BLISTER PACK in 1 CARTON (0113-0381-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0381

L. Perrigo Company good sense cold and flu severe 12 BLISTER PACK in 1 CARTON (0113-0299-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0299

DOH 690-292 May 2016 190 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL. Perrigo Company Good Sense cold 2 BLISTER PACK in 1 CARTON (0113-

0308-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0113-0308

L. Perrigo Company good sense flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (0113-0096-91)

650 mg/1, 20 mg/1, 10 mg/1


0113-0096

L. Perrigo Company Good Sense Daytime 177 mL in 1 BOTTLE (0113-0656-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


0113-0656



0113-0656



0113-0656



0113-0656

L. Perrigo Company good sense daytime 6 BLISTER PACK in 1 CARTON (0113-0994-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


0113-0994



0113-0994



0113-0994

DOH 690-292 May 2016 191 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL. Perrigo Company good sense daytime 8 BLISTER PACK in 1 CARTON (0113-



0113-0994

L. Perrigo Company Good Sense Cough DM 1 BOTTLE in 1 CARTON (0113-0958-21) > 89 mL in 1 BOTTLE


L. Perrigo Company Good Sense Cough DM 1 BOTTLE in 1 CARTON (0113-0958-28) > 148 mL in 1 BOTTLE


L. Perrigo Company Good Sense Nighttime Cough 177 mL in 1 BOTTLE (0113-0668-30) 30 mg/30mL, 12.5 mg/30mL


0113-0668

L. Perrigo Company Good Sense Nighttime Cough 237 mL in 1 BOTTLE (0113-0668-34) 30 mg/30mL, 12.5 mg/30mL


0113-0668

L. Perrigo Company good sense tussin dm 1 BOTTLE in 1 CARTON (0113-0578-26) > 118 mL in 1 BOTTLE


0113-0578

L. Perrigo Company Good Sense Adult Tussin DM 1 BOTTLE in 1 CARTON (0113-0934-26) > 118 mL in 1 BOTTLE


0113-0934

L. Perrigo Company Good Sense Childrens Mucus Relief Cough 1 BOTTLE in 1 CARTON (0113-0419-26) > 118 mL in 1 BOTTLE


0113-0419



0113-0359



0113-0359

L. Perrigo Company good sense tussin 1 BOTTLE in 1 CARTON (0113-0296-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


0113-0296

L. Perrigo Company good sense tussin 1 BOTTLE in 1 CARTON (0113-0296-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


0113-0296

DOH 690-292 May 2016 192 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCL. Perrigo Company Good Sense Childrens Mucus Relief 1 BOTTLE in 1 CARTON (0113-0839-



0113-0839

L. Perrigo Company Good Sense Tussin CF 1 BOTTLE in 1 CARTON (0113-0703-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


0113-0703

L. Perrigo Company Good Sense Tussin CF 1 BOTTLE in 1 CARTON (0113-0703-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


0113-0703

L.N.K. International, Inc. Multi-Symptom Cold Relief 1 BLISTER PACK in 1 BOX (50844-470-02) > 12 TABLET, FILM COATEDin 1 BLISTER PACK


50844-470

L.N.K. International, Inc. Cough and Cold HBP 2 BLISTER PACK in 1 CARTON (50844-911-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


50844-911

L.N.K. International, Inc. Cough and Cold HBP 2 BLISTER PACK in 1 CARTON (50844-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


50844-411

L.N.K. International, Inc. Mucus Relief Cough 1 BOTTLE in 1 CARTON (50844-733-01) > 30 TABLET in 1 BOTTLE


50844-733

LABORATORIO MAGNACHEM INTERNBRONCOCHEM 1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) > 120 mL in 1 BOTTLE,PLASTIC

250 mg/10mL, 4 mg/10mL, 13.33 mg/10mL, 200 mg/10mL, 5 mg/10mL

ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl

65131-116

LABORATORIO MAGNACHEM INTERNBRONCOCHEM 1 BOTTLE, PLASTIC in 1 BOX (65131-091-08) > 120 mL in 1 BOTTLE,PLASTIC

30 mg/10mL, 200 mg/10mL DEXTROMETHORPHAN HBr-GYAIFENESIN

65131-091

DOH 690-292 May 2016 193 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLABOTORIO MAGNACHEM INTERNATBRONCOCHEM 12 BOX in 1 BOX (65131-111-21) >

50 POUCH in 1 BOX (65131-111-95) > 2 TABLET, COATED in 1 POUCH

325 mg/1, 30 mg/1, 5 mg/1, 3 mg/1

Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate

65131-111

Larken Laboratories, Inc. LoHist DM 473 mL in 1 BOTTLE (68047-129-16) 2 mg/5mL, 10 mg/5mL, 5 mg/5mL


68047-129

Larken Laboratories, Inc. EndaCof DM 473 mL in 1 BOTTLE (68047-143-16) 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL


68047-143

Larken Laboratories, Inc. NoHist DM 473 mL in 1 BOTTLE (68047-186-16) 4 mg/5mL, 15 mg/5mL, 10 mg/5mL

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

68047-186

Laser Pharmaceuticals LLC Neo 473 mL in 1 BOTTLE (16477-562-01) 30 mg/5mL, 50 mg/5mL, 3 mg/5mL

Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, and Brompheniramine Maleate

16477-562

Laser Pharmaceuticals LLC Neo 30 mL in 1 BOTTLE (16477-562-30) 30 mg/5mL, 50 mg/5mL, 3 mg/5mL

Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, and Brompheniramine Maleate

16477-562

DOH 690-292 May 2016 194 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLaser Pharmaceuticals, LLC Donatussin 473 mL in 1 BOTTLE (16477-186-01) 4 mg/5mL, 20 mg/5mL, 10

mg/5mLChlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

16477-186

Laser Pharmaceuticals, LLC Donatussin DM Drops 1 BOTTLE in 1 CARTON (16477-811-30) > 30 mL in 1 BOTTLE


Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

16477-811

Laser Pharmaceuticals, LLC Neo DM DROPS 1 BOTTLE in 1 CARTON (16477-620-30) > 30 mL in 1 BOTTLE

2.75 mg/mL, .75 mg/mL, 1.75 mg/mL

Dextromethophan Hydrobromide, Chlorpheniramine Maleate, Phenylephrine Hydrochloride

16477-620

Lee Pharmaceuticals Cheracol D 1 BOTTLE, PLASTIC in 1 CARTON (23558-5504-0) > 118 mL in 1 BOTTLE, PLASTIC (23558-5504-1)

10 mg/5mL, 100 mg/5mL Maximum Strength Cough Relief

23558-5504

Lee Pharmaceuticals Cheracol D 1 BOTTLE, PLASTIC in 1 CARTON (23558-5504-2) > 177 mL in 1 BOTTLE, PLASTIC (23558-5504-3)

10 mg/5mL, 100 mg/5mL Maximum Strength Cough Relief

23558-5504

Lex Inc Baczol Cold Medicine 1 BOTTLE in 1 CARTON (49523-505-04) > 120 mL in 1 BOTTLE


ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, and CHLORPHENIRAMINE MALEATE

49523-505

Lil' Drug Store Products, Inc Circle K Nighttime Cold and Flu 6 BLISTER PACK in 1 CARTON (66715-5734-0) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


66715-5734

DOH 690-292 May 2016 195 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLil' Drug Store Products, Inc Circle K Nighttime Cold and Flu 237 mL in 1 BOTTLE (66715-5834-4) 650 mg/30mL, 30

mg/30mL, 12.5 mg/30mLAcetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate

66715-5834

Lil' Drug Store Products, Inc Cold and Flu Nighttime 6 BLISTER PACK in 1 CARTON (66715-6834-0) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


66715-6834

Lil' Drug Store Products, Inc Nighttime Cold and Flu 237 mL in 1 BOTTLE (66715-6934-4) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


66715-6934

Lil' Drug Store Products, Inc DayQuil Severe 1 POUCH in 1 CARTON (66715-9704-1) > 2 TABLET in 1 POUCH

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


66715-9704


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


66715-9704


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


66715-9704

DOH 690-292 May 2016 196 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLil' Drug Store Products, Inc DayQuil Severe 20 POUCH in 1 CARTON (66715-

9704-7) > 2 TABLET in 1 POUCH325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


66715-9704


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


66715-9704

Lil' Drug Store Products, Inc Circle K Cold 2 POUCH in 1 CARTON (66715-5728-2) > 2 TABLET in 1 POUCH

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


66715-5728

Lil' Drug Store Products, Inc Daytime Cold and Flu 6 BLISTER PACK in 1 CARTON (66715-5731-0) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


66715-5731

Lil' Drug Store Products, Inc Circle K Daytime 237 mL in 1 BOTTLE (66715-5831-4) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


66715-5831

Lil' Drug Store Products, Inc Cold and Flu Daytime 6 BLISTER PACK in 1 CARTON (66715-6831-0) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


66715-6831

DOH 690-292 May 2016 197 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLil' Drug Store Products, Inc Daytime Cold and Flu 6 BLISTER PACK in 1 CARTON



66715-5631

Lil' Drug Store Products, Inc Daytime Cold and Flu 237 mL in 1 BOTTLE (66715-6931-4) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


66715-6931

Lil' Drug Store Products, Inc Adult Tussin DM 1 BOTTLE in 1 CARTON (66715-6858-4) > 118 mL in 1 BOTTLE


66715-6858

Lil' Drug Store Products, Inc. NyQuil 1 BLISTER PACK in 1 CARTON (66715-9713-0) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate

66715-9713

Lil' Drug Store Products, Inc. NyQuil 1 POUCH in 1 CARTON (66715-9713-1) > 2 CAPSULE, LIQUID FILLED in 1POUCH

325 mg/1, 15 mg/1, 6.25 mg/1


66715-9713


325 mg/1, 15 mg/1, 6.25 mg/1


66715-9713


325 mg/1, 15 mg/1, 6.25 mg/1


66715-9713

DOH 690-292 May 2016 198 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLil' Drug Store Products, Inc. NyQuil 4 POUCH in 1 CARTON (66715-9713-

8) > 2 CAPSULE, LIQUID FILLED in 1POUCH

325 mg/1, 15 mg/1, 6.25 mg/1


66715-9713

Lil' Drug Store Products, Inc. Lil Drug Store Cold Relief 3 POUCH in 1 CARTON (66715-9728-3) > 2 TABLET in 1 POUCH

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


66715-9728


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


66715-9728


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


66715-9728


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


66715-9828


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


66715-9828

DOH 690-292 May 2016 199 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLil' Drug Store Products, Inc. Lil Drug Store Cold Relief 10 POUCH in 1 CARTON (66715-

9828-8) > 2 TABLET in 1 POUCH325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


66715-9828

Lil' Drug Store Products, Inc. DayQuil 1 BLISTER PACK in 1 CARTON (66715-9708-0) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


66715-9708

Lil' Drug Store Products, Inc. DayQuil 1 POUCH in 1 CARTON (66715-9708-1) > 2 CAPSULE, LIQUID FILLED in 1POUCH


66715-9708



66715-9708



66715-9708

Lil' Drug Store Products, Inc. Mucinex DM 1 POUCH in 1 CARTON (66715-9724-1) > 2 TABLET in 1 POUCH


66715-9724

LIVE BETTER (The Great Atlantic & PaNighttime Cold Flu Relief 2 BLISTER PACK in 1 CARTON (53187-480-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


53187-480

DOH 690-292 May 2016 200 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLIVE BETTER (The Great Atlantic & PaDaytime 2 BLISTER PACK in 1 CARTON



53187-470

LLC Federal Solutions Guaifenesin and Dextromethorphan Hydrobromide 100 CUP, UNIT-DOSE in 1 BOX (24451-133-05) > 5 mL in 1 CUP, UNIT-DOSE


24451-133

LLC Federal Solutions Guaifenesin and Dextromethorphan Hydrobromide 100 CUP, UNIT-DOSE in 1 BOX (24451-133-10) > 10 mL in 1 CUP, UNIT-DOSE


24451-133

Llorens Pharmaceutical International Tusnel 178 mL in 1 BOTTLE (54859-502-06) 15 mg/5mL, 200 mg/5mL, 30 mg/5mL

Dextromethorphan, Guiafenesin, Pseudoephedrine HCl

54859-502

Llorens Pharmaceutical International Tusnel 3786 mL in 1 BOTTLE (54859-502-10)

15 mg/5mL, 200 mg/5mL, 30 mg/5mL


54859-502



54859-502



54859-544

Llorens Pharmaceutical International Tusnel DM 60 mL in 1 BOTTLE, DROPPER (54859-603-02)

25 mg/mL, 7.5 mg/mL, 2.5 mg/mL


54859-603

LLORENS PHARMACEUTICALS INTERNTusnel Diabetic 118 mL in 1 BOTTLE (54859-505-04) 10 mg/5mL, 100 mg/5mL Dextromethorphan, Guaifenesin

54859-505

LLORENS PHARMACEUTICALS INTERNTusnel Diabetic 472 mL in 1 BOTTLE (54859-505-16) 10 mg/5mL, 100 mg/5mL Dextromethorphan, Guaifenesin

54859-505

DOH 690-292 May 2016 201 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCLLORENS PHARMACEUTICALS INTERNTusnel 60 TABLET in 1 BOTTLE (54859-801-

60)30 mg/1, 400 mg/1, 60 mg/1

Dextromethorphan HBr, Guaifenesin, Pseudoephedrine HCl

54859-801

Major Pharmaceuticals Childrens Plus Cough and Runny Nose 118 mL in 1 BOTTLE, PLASTIC (0904-5874-20)



0904-5874

Major Pharmaceuticals all nite 237 mL in 1 BOTTLE (0904-6465-09) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0904-6465

Major Pharmaceuticals Major Night Time Multi Symptom 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0904-5764-12)

325 mg/1, 15 mg/1, 6.25 mg/1


0904-5764

Major Pharmaceuticals Major Night Time Multi Symptom 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0904-5764-44)

325 mg/1, 15 mg/1, 6.25 mg/1


0904-5764

Major Pharmaceuticals All-Nite Cold and Flu 177 mL in 1 BOTTLE (0904-5776-21) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0904-5776

Major Pharmaceuticals All-Nite Cold and Flu 237 mL in 1 BOTTLE (0904-5777-09) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0904-5777

M

DOH 690-292 May 2016 202 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMajor Pharmaceuticals Multi-Symptom Mapap Cold Formula 2 BLISTER PACK in 1 CARTON (0904-

5786-24) > 12 TABLET in 1 BLISTER PACK


0904-5786

Major Pharmaceuticals Day Time Cold and Flu Relief 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0904-5763-12)


0904-5763

Major Pharmaceuticals Day Time Cold and Flu Relief 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0904-5763-44)


0904-5763

Major Pharmaceuticals dimaphen dm 1 BOTTLE in 1 CARTON (0904-6463-20) > 118 mL in 1 BOTTLE



0904-6463

Major Pharmaceuticals DIBROMM 118 mL in 1 BOTTLE, PLASTIC (0904-5782-20)


BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE

0904-5782

Major Pharmaceuticals Cough and Cold 2 BLISTER PACK in 1 CARTON (0904-5817-44) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


0904-5817

Major Pharmaceuticals Robafen Cough 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (0904-5752-95)


Major Pharmaceuticals Cough Relief 118 mL in 1 BOTTLE, PLASTIC (0904-5875-20)


0904-5875

Major Pharmaceuticals cough dm 1 BOTTLE in 1 CARTON (0904-6312-56) > 89 mL in 1 BOTTLE


DOH 690-292 May 2016 203 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMajor Pharmaceuticals Tussin DM 118 mL in 1 BOTTLE, PLASTIC (0904-

0053-20)10 mg/5mL, 100 mg/5mL Dextromethorphan

Hydrobromide and GUAIFENESIN

0904-0053

Major Pharmaceuticals Tussin Sugar Free Cough 118 mL in 1 BOTTLE, PLASTIC (0904-5180-20)


0904-5180

Major Pharmaceuticals Mucus Relief DM 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0904-6013-40)


0904-6013

Major Pharmaceuticals Robafen DM Max 1 BOTTLE in 1 CARTON (0904-6046-20) > 118 mL in 1 BOTTLE


0904-6046

Major Pharmaceuticals robafen 1 BOTTLE in 1 CARTON (0904-6464-20) > 118 mL in 1 BOTTLE


0904-6464

Major Pharmaceuticals Tussin Multi Symptom Cold CF 1 BOTTLE, PLASTIC in 1 BOX (0904-6537-20) > 118 mL in 1 BOTTLE, PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


0904-6537

Major Pharmaceuticals Tussin CF 118 mL in 1 BOTTLE, PLASTIC (0904-5770-20)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


0904-5770

Major Pharmaceuticals Robafen DM Cough Sugar Free Clear 118 mL in 1 BOTTLE (0904-6306-20) 100 mg/5mL, 10 mg/5mL Guaifenesin and Dextromethorphan Hydrobromide

0904-6306

Major Pharmaceuticals Robafen CF Cough and cold 1 BOTTLE in 1 CARTON (0904-6309-20) > 118 mL in 1 BOTTLE

100 mg/5mL, 10 mg/5mL, 5 mg/5mL

Guaifenesin, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride

0904-6309

MAJOR PHARMACEUTICALS INC MUCUS RELIEF DM 30 TABLET in 1 BOTTLE, PLASTIC (0904-6233-46)

400 mg/1, 20 mg/1 GUAIFENESIN, DEXTROMETHORPHAN HBr

0904-6233

DOH 690-292 May 2016 204 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMAJOR PHARMACEUTICALS INC MUCUS RELIEF DM 60 TABLET in 1 BOTTLE, PLASTIC

(0904-6233-52)400 mg/1, 20 mg/1 GUAIFENESIN,

DEXTROMETHORPHAN HBr0904-6233

Major Pharmaceuticals, Inc Pedia Relief 120 mL in 1 BOTTLE, PLASTIC (0904-5050-20)


Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide

0904-5050

Major Pharmeceuticals Tussin Sugar Free Cough 237 mL in 1 BOTTLE, PLASTIC (0904-5180-09)


0904-5180

Marc Glassman, Inc. Nighttime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (68998-343-12)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68998-343

Marc Glassman, Inc. Nighttime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (68998-344-12)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68998-344

Marc Glassman, Inc. Daytime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (68998-466-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68998-466

Marc Glassman, Inc. Day Time Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (68998-311-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


68998-311

Marc Glassman, Inc. Night Time Cough 355 mL in 1 BOTTLE, PLASTIC (68998-345-12)

30 mg/30mL, 12.5 mg/30mL


68998-345

DOH 690-292 May 2016 205 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMarc Glassman, Inc. Tussin DM 1 BOTTLE, PLASTIC in 1 BOX (68998-



68998-385

Marc Glassman, Inc. TUSSIN DM MAX ADULT COUGH PLUS CHEST CONGESTION



68998-386

Marc Glassman, Inc. Tussin CF 237 mL in 1 BOTTLE, PLASTIC (68998-382-08)

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


68998-382

Matrixx Initiatives, Inc. Zicam 240 mL in 1 BOTTLE, UNIT-DOSE (62750-023-10)

325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL


62750-023

Matrixx Initiatives, Inc. Zicam 240 mL in 1 BOTTLE, UNIT-DOSE (62750-022-10)

325 mg/15mL, 10 mg/15mL, 200 mg/15mL

acetaminophen, dextromethorphan hydrobromide and guaifenesin

62750-022

Matrixx Initiatives, Inc. Duract 2 BLISTER PACK in 1 CARTON (62750-041-10) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK


62750-041

Matrixx Initiatives, Inc. Duract 2 BLISTER PACK in 1 CARTON (62750-042-10) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK


62750-042

Matrixx Initiatives, Inc. Zicam 1 BOTTLE, PLASTIC in 1 CARTON (62750-016-10) > 16.3 mL in 1 BOTTLE, PLASTIC

6 mg/.25mL dextromethorphan hydrobromide

62750-016

DOH 690-292 May 2016 206 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMcKesson sunmark Cold 1 BOTTLE in 1 CARTON (49348-879-



49348-879

McKesson health mart night time cold and flu 296 mL in 1 BOTTLE (62011-0082-1) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


62011-0082

McKesson health mart night time cold and flu 355 mL in 1 BOTTLE (62011-0082-2) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


62011-0082

McKesson health mart night time 296 mL in 1 BOTTLE (62011-0083-1) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


62011-0083

McKesson health mart night time 355 mL in 1 BOTTLE (62011-0083-2) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


62011-0083

McKesson sunmark nite time 177 mL in 1 BOTTLE (49348-975-36) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49348-975



49348-975



49348-975



49348-975

DOH 690-292 May 2016 207 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMcKesson Sunmark nite time 177 mL in 1 BOTTLE (49348-742-36) 500 mg/15mL, 15


49348-742

McKesson Sunmark nite time 295 mL in 1 BOTTLE (49348-742-49) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49348-742

McKesson McKesson Nite Time 177 mL in 1 BOTTLE (49348-743-36) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49348-743

McKesson McKesson Nite Time 295 mL in 1 BOTTLE (49348-743-49) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49348-743

Mckesson sunmark nite time 177 mL in 1 BOTTLE (49348-061-36) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49348-061



49348-061



49348-061



49348-061

DOH 690-292 May 2016 208 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMcKesson sunmark nite time d 295 mL in 1 BOTTLE (49348-845-49) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mL, 30 mg/15mL


49348-845

Mckesson adult cold, flu and sore throat 177 mL in 1 BOTTLE (62011-0193-1) 650 1/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL

acteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl

62011-0193

Mckesson HealthMart Mucus Relief FM 2 BLISTER PACK in 1 CARTON (62011-0218-1) > 10 TABLET in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, dextromethorphan HBr, guaifenesin, Phenylephrine HCl

62011-0218

Mckesson HealthMart Mucus Relief FM 2 BLISTER PACK in 1 CARTON (62011-0219-1) > 10 TABLET in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, dextromethorphan HBr, guaifenesin, Phenylephrine HCl

62011-0219

McKesson Health Mart Daytime 6 BLISTER PACK in 1 CARTON (62011-0239-1) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


62011-0239

McKesson Severe Cold and Flu 2 BLISTER PACK in 1 CARTON (62011-0241-1) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


62011-0241

DOH 690-292 May 2016 209 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMcKesson Sunmark cold head congestion 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49348-840

McKesson sunmark cold and flu severe 12 BLISTER PACK in 1 CARTON (49348-104-04) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49348-104

McKesson Cold and Flu Severe 2 BLISTER PACK in 1 CARTON (49348-118-04) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49348-118

Mckesson adult cold, flu and sore throat 177 mL in 1 BOTTLE (49348-080-36) 650 1/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL

acteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl

49348-080

McKesson Sunmark Cold Head Congestion 2 BLISTER PACK in 1 CARTON (49348-791-04) > 12 TABLET, FILM COATED in 1 BLISTER PACK


49348-791

McKesson Sunmark Day time 177 mL in 1 BOTTLE (49348-753-36) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49348-753

McKesson Sunmark Day time 237 mL in 1 BOTTLE (49348-753-37) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49348-753

DOH 690-292 May 2016 210 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMckesson health mart daytime 177 mL in 1 BOTTLE (62011-0065-1) 325 mg/15mL, 10


62011-0065

Mckesson health mart daytime 236 mL in 1 BOTTLE (62011-0065-2) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


62011-0065

McKesson health mart severe cold cough and flu 6 POWDER, FOR SOLUTION in 1 CARTON (62011-0253-1)

650 mg/1, 20 mg/1, 10 mg/1


62011-0253

McKesson Health Mart Cold and Cough 1 BOTTLE in 1 CARTON (62011-0063-1) > 118 mL in 1 BOTTLE



62011-0063

McKesson SUNMARK COLD AND COUGH DM 1 BOTTLE in 1 CARTON (49348-775-34) > 118 mL in 1 BOTTLE



49348-775

McKesson Sunmark cough dm 1 BOTTLE in 1 CARTON (49348-100-84) > 89 mL in 1 BOTTLE


McKesson Sunmark cough dm 1 BOTTLE in 1 CARTON (49348-315-84) > 89 mL in 1 BOTTLE


McKesson Health Mart Cough DM 1 BOTTLE in 1 CARTON (62011-0198-1) > 89 mL in 1 BOTTLE


McKesson Health Mart Cough DM 1 BOTTLE in 1 CARTON (62011-0176-1) > 89 mL in 1 BOTTLE


McKesson health mart cough dm 1 BOTTLE in 1 CARTON (62011-0251-1) > 89 mL in 1 BOTTLE


McKesson sunmark nite time 177 mL in 1 BOTTLE (49348-540-36) 15 mg/15mL, 6.25 mg/15mL


49348-540

DOH 690-292 May 2016 211 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMcKesson health mart adult tussin 1 BOTTLE in 1 CARTON (62011-0091-

1) > 118 mL in 1 BOTTLE20 mg/10mL, 200 mg/10mL Dextromethorphan


McKesson health mart adult tussin 1 BOTTLE in 1 CARTON (62011-0091-2) > 237 mL in 1 BOTTLE


62011-0091



62011-0092



62011-0092

McKesson HealthMart Chest Congestion Relief DMDM 1 BOTTLE in 1 CARTON (62011-0061-1) > 50 TABLET in 1 BOTTLE


62011-0061

McKesson Health Mart Adult Tussin 1 BOTTLE in 1 CARTON (62011-0211-1) > 118 mL in 1 BOTTLE


62011-0211

McKesson Sunmark Chest Congestion Relief DM 1 BOTTLE in 1 CARTON (49348-728-09) > 50 TABLET in 1 BOTTLE


49348-728

McKesson Sunmark Adult Tussin 1 BOTTLE in 1 CARTON (49348-421-84) > 118 mL in 1 BOTTLE


49348-421

McKesson Sun Mark Tussin DM 1 BOTTLE in 1 CARTON (49348-017-34) > 118 mL in 1 BOTTLE


49348-017



49348-017



49348-017

McKesson Sun Mark Mucus Relief Cough 1 BOTTLE in 1 CARTON (49348-828-34) > 118 mL in 1 BOTTLE


49348-828

McKesson sunmark tussin dm 1 BOTTLE in 1 CARTON (49348-861-34) > 118 mL in 1 BOTTLE


49348-861

McKesson sunmark tussin dm 1 BOTTLE in 1 CARTON (49348-861-37) > 237 mL in 1 BOTTLE


49348-861

DOH 690-292 May 2016 212 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMckesson adult severe congestion and cough 177 mL in 1 BOTTLE (49348-083-36) 20 mg/20mL, 400

mg/20mL, 10 mg/20mLDextromethorphan HBr, Guaifenesin, Phenylephrine HCl

49348-083

McKesson SUNMARK TUSSIN CF 1 BOTTLE in 1 CARTON (49348-737-34) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49348-737

McKesson SUNMARK TUSSIN CF 1 BOTTLE in 1 CARTON (49348-737-37) > 236 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49348-737


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


62011-0090

McKesson sunmark day time cold and cough 1 BOTTLE in 1 CARTON (49348-841-34) > 118 mL in 1 BOTTLE


49348-841

McKesson (Health Mart) Health Mart Multi-Symptom Cold and Flu Night Time 1 BOX in 1 BOX (62011-0084-1) > 12 CAPSULE, LIQUID FILLED in 1 BOX

325 mg/1, 15 mg/1, 6.25 mg/1


62011-0084

McKesson (Health Mart) NightTime Cold and Flu 16 BLISTER PACK in 1 CARTON (62011-0262-1) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


62011-0262

McKesson (Health Mart) NON-DROWSY DAY TIME 1 BLISTER PACK in 1 BOX (62011-0066-1) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL

62011-0066

McKesson (Health Mart) NON-DROWSY DAY TIME 1 BLISTER PACK in 1 BOX (62011-0066-2) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


62011-0066

DOH 690-292 May 2016 213 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMcKesson (Health Mart) Daytime 24 BLISTER PACK in 1 CARTON



62011-0261

McKesson (Sunmark) Nite time 1 BLISTER PACK in 1 CARTON (49348-741-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49348-741


325 mg/1, 15 mg/1, 6.25 mg/1


49348-741


325 mg/1, 15 mg/1, 6.25 mg/1


49348-741

McKesson (Sunmark) Nighttime 16 BLISTER PACK in 1 CARTON (49348-157-03) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49348-157

McKesson (Sunmark) Day Time Cold and Flu 24 BLISTER PACK in 1 CARTON (49348-142-04) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


49348-142

McKesson (Sunmark) Day Time PE 1 BLISTER PACK in 1 CARTON (49348-738-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


49348-738

McKesson (Sunmark) Day Time PE 2 BLISTER PACK in 1 CARTON (49348-738-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


49348-738

DOH 690-292 May 2016 214 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMcKesson (Sunmark) Day Time PE 2 BLISTER PACK in 1 CARTON



49348-738

McLaren Medical G-Tuss-NL 473 mL in 1 BOTTLE, PLASTIC (43913-404-16)

10 mg/5mL, 200 mg/5mL, 30 mg/5mL

Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride

43913-404

McLaren Medical G-Tuss-NL Ped 473 mL in 1 BOTTLE, PLASTIC (43913-406-16)



43913-406

McLaren Medical G-Xpect PSE 473 mL in 1 BOTTLE, PLASTIC (43913-407-16)

10 mg/5mL, 200 mg/5mL, 30 mg/5mL


43913-407

MCLAREN MEDICAL INC G-BRONCO-D 474 mL in 1 BOTTLE (43913-403-16) 200 mg/5mL, 10 mg/5mL, 5 mg/5mL

GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

43913-403

MCR American Pharmaceuticals, Inc. BroveX PEB DM 473 mL in 1 BOTTLE, PLASTIC (58605-153-01)



58605-153

MCR American Pharmaceuticals, Inc. BroveX PEB DM 20 mL in 1 BOTTLE, PLASTIC (58605-153-02)



58605-153

DOH 690-292 May 2016 215 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMCR American Pharmaceuticals, Inc. Allfen DM 100 TABLET in 1 BOTTLE, PLASTIC

(58605-401-01)400 mg/1, 20 mg/1 GUAIFENESIN and


58605-401

MCR American Pharmaceuticals, Inc. Allfen DM 20 TABLET in 1 BLISTER PACK (58605-401-02)

400 mg/1, 20 mg/1 GUAIFENESIN and Dextromethorphan Hydrobromide

58605-401

MCR American Pharmaceuticals, Inc. Maxiphen DM 100 TABLET in 1 BOTTLE, PLASTIC (58605-423-01)

400 mg/1, 10 mg/1, 20 mg/1

Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide

58605-423

MCR American Pharmaceuticals, Inc. Maxiphen DM 20 TABLET in 1 BLISTER PACK (58605-423-02)

400 mg/1, 10 mg/1, 20 mg/1

Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide

58605-423

MCR American Pharmaceuticals, Inc. BroveX PSB DM 473 mL in 1 BOTTLE, PLASTIC (58605-151-01)


Pseudoephedrine Hydrochloride, Brompheniramine Maleate, and Dextromethorphan Hydrobromide

58605-151

MCR American Pharmaceuticals, Inc. BroveX PSB DM 20 mL in 1 BOTTLE, PLASTIC (58605-151-02)


Pseudoephedrine Hydrochloride, Brompheniramine Maleate, and Dextromethorphan Hydrobromide

58605-151

Mechanical Servants, Inc. Vicks NyQuil 1 POUCH in 1 PACKAGE (29485-2828-5) > 2 CAPSULE, LIQUID FILLED in 1 POUCH

325 mg/1, 15 mg/1, 6.25 mg/1


29485-2828

DOH 690-292 May 2016 216 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMechanical Servants, Inc. Vicks DayQuil 1 POUCH in 1 PACKAGE (29485-

2827-8) > 2 CAPSULE, LIQUID FILLED in 1 POUCH


29485-2827

Meda Consumer Healthcare Inc. Contac Cold and Flu 236 mL in 1 BOTTLE, PLASTIC (46017-026-08)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid

46017-026

Medicine Shoppe International Inc Tussin DM 1 BOTTLE in 1 CARTON (49614-360-26) > 118 mL in 1 BOTTLE


49614-360

Medtech Products Inc. Little Colds Multi Symptom Cold 1 BOTTLE, DROPPER in 1 BOX (63029-404-01) > 30 mL in 1 BOTTLE, DROPPER

80 mg/mL, 2.5 mg/mL, 1.25 mg/mL

Acetaminophen and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

63029-404

Medtech Products Inc. Little Colds Multi Symptom Cold 1 BOTTLE in 1 BOX (63029-405-01) > 118 mL in 1 BOTTLE


acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

63029-405

Medtech Products Inc. BC 4 POWDER in 1 CARTON (63029-215-04)

600 mg/1, 20 mg/1, 10 mg/1

acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride

63029-215

Medtech Products Inc. BC 12 POWDER in 1 CARTON (63029-215-12)

600 mg/1, 20 mg/1, 10 mg/1

acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride

63029-215

Medtech Products Inc. Little Colds Decongestant Plus Cough 1 BOTTLE, DROPPER in 1 BOX (63029-402-01) > 30 mL in 1 BOTTLE, DROPPER

5 mg/mL, 2.5 mg/mL Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

63029-402

DOH 690-292 May 2016 217 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Nite time Severe Cold and Flu 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


41250-877

Meijer Mucus Relief 3 BLISTER PACK in 1 VIAL (41250-616-01) > 10 TABLET, FILM COATEDin 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41250-616

Meijer Cold and Flu Severe 2 BLISTER PACK in 1 CARTON (41250-663-05) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41250-663

Meijer Mucus Relief 3 BLISTER PACK in 1 CARTON (41250-717-01) > 10 TABLET in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41250-717

Meijer Cold and Cough PE 1 BLISTER PACK in 1 CARTON (41250-134-03) > 10 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


41250-134

Meijer Cold and Sinus PE Pressure, Pain and Cold 2 BLISTER PACK in 1 CARTON (41250-465-08) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


41250-465

DOH 690-292 May 2016 218 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Cold Relief Multi-Symptom Daytime 2 BLISTER PACK in 1 CARTON



41250-138

Meijer Cough and Sinus PE Pressure, Pain and Cough 2 BLISTER PACK in 1 CARTON (41250-511-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK


41250-511

Meijer Mucus Relief DM 1 BOTTLE, PLASTIC in 1 CARTON (41250-533-11) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC


41250-533

Meijer Distribution Inc Pain Relief Plus 1 BOTTLE in 1 CARTON (41250-903-26) > 118 mL in 1 BOTTLE



41250-903

Meijer Distribution Inc cold relief 2 BLISTER PACK in 1 CARTON (41250-014-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


41250-014

Meijer Distribution Inc cold relief 2 BLISTER PACK in 1 CARTON (41250-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


41250-393

Meijer Distribution Inc cough and sore throat 237 mL in 1 BOTTLE (41250-698-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

41250-698

DOH 690-292 May 2016 219 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Distribution Inc cough and sore throat 237 mL in 1 BOTTLE (41250-666-34) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mLAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate

41250-666

Meijer Distribution Inc Nite Time 295 mL in 1 BOTTLE (41250-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41250-908



41250-908



41250-908

Meijer Distribution Inc NiteTime Cold and Flu 12 BLISTER PACK in 1 CARTON (41250-977-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41250-977



41250-990

Meijer Distribution Inc nitetime cold and flu 355 mL in 1 BOTTLE (41250-872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


41250-872



41250-459



41250-459

DOH 690-292 May 2016 220 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Distribution Inc nitetime cold and flu 473 mL in 1 BOTTLE (41250-459-43) 650 mg/30mL, 30


41250-459



41250-335



41250-335



41250-335

Meijer Distribution Inc Nite Time Cold and Flu 296 mL in 1 BOTTLE (41250-041-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41250-041

Meijer Distribution Inc Nite Time Cold and Flu 473 mL in 1 BOTTLE (41250-041-43) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41250-041

Meijer Distribution Inc nitetime cold and flu 12 BLISTER PACK in 1 CARTON (41250-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41250-056

Meijer Distribution Inc nitetime cold and flu 355 mL in 1 BOTTLE (41250-811-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


41250-811

DOH 690-292 May 2016 221 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Distribution Inc Nitetime Cold and Flu 355 mL in 1 BOTTLE (41250-763-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


41250-763

Meijer Distribution Inc Nitetime Cold and Flu 2 BOTTLE in 1 PACKAGE (41250-763-50) > 355 mL in 1 BOTTLE



41250-763

Meijer Distribution Inc Nitetime D 296 mL in 1 BOTTLE (41250-550-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL


41250-550

Meijer Distribution Inc Nitetime D 296 mL in 1 BOTTLE (41250-609-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL


41250-609

Meijer Distribution Inc Daytime Cold and Flu 355 mL in 1 BOTTLE (41250-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


41250-603

Meijer Distribution Inc daytime cold and flu 12 BLISTER PACK in 1 CARTON (41250-548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41250-548

Meijer Distribution Inc cold and flu severe 12 BLISTER PACK in 1 CARTON (41250-300-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41250-300

DOH 690-292 May 2016 222 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Distribution Inc cold relief 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41250-308

Meijer Distribution Inc Cold relief 2 BLISTER PACK in 1 CARTON (41250-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41250-234

Meijer Distribution Inc Cold Relief 2 BLISTER PACK in 1 CARTON (41250-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


41250-402

Meijer Distribution Inc DayTime Cold and Flu 12 BLISTER PACK in 1 CARTON (41250-361-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41250-361

Meijer Distribution Inc DayTime Cold and Flu 12 BLISTER PACK in 1 CARTON (41250-994-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41250-994

Meijer Distribution Inc Daytime cold and flu 296 mL in 1 BOTTLE (41250-656-38) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41250-656

Meijer Distribution Inc Daytime cold and flu 355 mL in 1 BOTTLE (41250-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41250-656

Meijer Distribution Inc cold and cough 1 BOTTLE in 1 CARTON (41250-987-26) > 118 mL in 1 BOTTLE



41250-987

DOH 690-292 May 2016 223 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Distribution Inc cold and cough 1 BOTTLE in 1 CARTON (41250-987-



41250-987

Meijer Distribution Inc Cough DM 1 BOTTLE in 1 CARTON (41250-384-21) > 89 mL in 1 BOTTLE




Meijer Distribution Inc daytime cough 296 mL in 1 BOTTLE (41250-473-38) 15 mg/15mL Dextromethorphan HBr 41250-473

Meijer Distribution Inc daytime cough 355 mL in 1 BOTTLE (41250-473-40) 15 mg/15mL Dextromethorphan HBr 41250-473





Meijer Distribution Inc cough dm 1 BOTTLE in 1 CARTON (41250-899-28) > 148 mL in 1 BOTTLE




Meijer Distribution Inc Nitetime Cough 177 mL in 1 BOTTLE (41250-668-30) 30 mg/30mL, 12.5 mg/30mL


41250-668



41250-668



41250-668

DOH 690-292 May 2016 224 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Distribution Inc Cough Syrup 1 BOTTLE in 1 CARTON (41250-578-



Meijer Distribution Inc Cough Syrup 1 BOTTLE in 1 CARTON (41250-578-34) > 237 mL in 1 BOTTLE


41250-578

Meijer Distribution Inc cough and chest congestion 1 BOTTLE in 1 CARTON (41250-704-34) > 237 mL in 1 BOTTLE


41250-704

Meijer Distribution Inc tussin cough 1 BOTTLE in 1 CARTON (41250-799-34) > 237 mL in 1 BOTTLE


41250-799

Meijer Distribution Inc cough plus chest congestion 1 BOTTLE in 1 CARTON (41250-910-34) > 237 mL in 1 BOTTLE


41250-910

Meijer Distribution Inc cough 1 BOTTLE in 1 CARTON (41250-359-34) > 237 mL in 1 BOTTLE


41250-359



41250-359

Meijer Distribution Inc cough and chest congestion 1 BOTTLE in 1 CARTON (41250-280-34) > 237 mL in 1 BOTTLE


41250-280

Meijer Distribution Inc cough syrup 1 BOTTLE in 1 CARTON (41250-296-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


41250-296

Meijer Distribution Inc multi symptom cold 1 BOTTLE in 1 CARTON (41250-453-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


41250-453

Meijer Distribution Inc childrens multi symptom cold 1 BOTTLE in 1 CARTON (41250-839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


41250-839


10 mg/5mL, 100 mg/5mL, 5 mg/5mL


41250-516


10 mg/5mL, 100 mg/5mL, 5 mg/5mL


41250-516

DOH 690-292 May 2016 225 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMeijer Distribution Inc Adult CF Cough 1 BOTTLE in 1 CARTON (41250-699-



41250-699

Meijer Distribution Inc multi symptom cold 1 BOTTLE in 1 CARTON (41250-605-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


41250-605

Meijer Distribution, Inc. Mixed Berry Sore Throat and Cough lozenge 18 LOZENGE in 1 CARTON (41250-066-18)

7.5 mg/1, 5 mg/1 Dextromethorphan Hydrobromide

41250-066

MEIJER, INC. NiteTime Cold Flu Relief 24 BLISTER PACK in 1 CARTON (41250-480-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41250-480

MEIJER, INC. Night Time Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (41250-471-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41250-471

MEIJER, INC. DayTime Cold and Flu 24 BLISTER PACK in 1 CARTON (41250-568-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41250-568

MEIJER, INC. Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (41250-336-06)



41250-336

MEIJER, INC. Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (41250-137-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


41250-137

Melaleuca, Inc. CounterAct 3 BLISTER PACK in 1 BOX (54473-185-36) > 12 TABLET, FILM COATEDin 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine

54473-185

DOH 690-292 May 2016 226 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMelaleuca, Inc. CounterAct 1 BOTTLE in 1 BOX (54473-080-04)

> 118 mL in 1 BOTTLE10 mg/5mL, 100 mg/5mL Dextromethorphan HBr. and


Menper Distributors Inc. Defensol D (Multi Symptom Effervescent Tablets) 6 POUCH in 1 BOX (53145-320-06) > 2 TABLET, EFFERVESCENT in 1 POUCH (53145-320-02)

250 mg/2501, 2 mg/2501, 10 mg/2501, 5 mg/2501

Acetaminophen 250mg, Chlorpheniramine maleate 2mg, Dextromethorphan hydrobromide 10mg, Phenylephrine hydrochloride 5mg

53145-320

MENPER DISTRIBUTORS INC. Bisolvine 120 mL in 1 BOTTLE, PLASTIC (53145-321-04)

100 mg/5mL, 10 mg/5mL Guaifenesin, Dextromethorphan

53145-321

Menper Distributors, Inc Defensol-ito 1 BOTTLE, DROPPER in 1 CARTON (53145-333-15) > 30 mL in 1 BOTTLE, DROPPER


Dextromethorphan, Guiafenesin, Phenylephrine

53145-333

Menper Distributors, Inc. Cosedal Drops 1 BOTTLE, DROPPER in 1 CARTON (53145-059-02) > 60 mL in 1 BOTTLE, DROPPER

10 mg/5mL, 100 mg/5mL Dextromethorphan HBR, Guaifenesin

53145-059

Menper Distributors, Inc. Toa Syrup Adult 120 mL in 1 CARTON (53145-302-84)

10 mg/5mL, 5 mg/5mL Toa Syrup Adult 53145-302

Menper Distributors, Inc. Broncofin 120 mL in 1 CARTON (53145-026-34)

10 mg/5mL, 5 mg/5mL Broncofin 53145-026

Menper Distributors, Inc. Bronco Pulmonar Syrup 1 BOTTLE in 1 CARTON (53145-030-04) > 120 mL in 1 BOTTLE

100 mg/5mL, 10 mg/5mL Guaifenesin, Dextromethrophan HBR

53145-030

Menper Distributors, Inc. Pulmovac 1 BOTTLE in 1 CARTON (53145-031-06) > 180 mL in 1 BOTTLE

100 mg/5mL, 10 mg/5mL Guaifenesin, Dextromethorphan HBR

53145-031

Menper Distributors, Inc. Bronkisan 1 BOTTLE in 1 CARTON (53145-032-06) > 180 mL in 1 BOTTLE


53145-032

Menper Distributors, Inc. Defensol Adult Syrup 1 BOTTLE in 1 CARTON (53145-039-04) > 120 mL in 1 BOTTLE


53145-039

DOH 690-292 May 2016 227 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCMenper Distributors, Inc. Breacold Adult 1 BOTTLE in 1 CARTON (53145-040-

04) > 180 mL in 1 BOTTLE100 mg/5mL, 10 mg/5mL Guaifenesin,

Dextromethorphan HBr53145-040

Menper Distributors, Inc. Breacold Children 1 BOTTLE in 1 CARTON (53145-007-04) > 120 mL in 1 BOTTLE


53145-007

Menper Distributors, Inc. Defensolito Children Syrup 1 BOTTLE in 1 CARTON (53145-008-04) > 120 mL in 1 BOTTLE


53145-008

Moore Medical LLC Moore Medical MooreBrand Severe Cold Relief 250 PACKET in 1 BOX, UNIT-DOSE (55670-143-13) > 2 TABLET, FILM COATED in 1 PACKET (55670-143-99)

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


55670-143

MSD Consumer Care, Inc. Coricidin HBP Maximum Strength Flu 1 BLISTER PACK in 1 CARTON (11523-1305-1) > 10 TABLET, FILM COATED in 1 BLISTER PACK

500 mg/1, 2 mg/1, 15 mg/1 Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide

11523-1305

MSD Consumer Care, Inc. Coricidin HBP Maximum Strength Flu 2 BLISTER PACK in 1 CARTON (11523-1305-2) > 10 TABLET, FILM COATED in 1 BLISTER PACK

500 mg/1, 2 mg/1, 15 mg/1 Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide

11523-1305

MSD Consumer Care, Inc. Coricidin HBP Cough and Cold 2 BLISTER PACK in 1 CARTON (11523-4326-1) > 8 TABLET, FILM COATED in 1 BLISTER PACK

4 mg/1, 30 mg/1 Chlorpheniramine maleate and Dextromethorphan hydrobromide

11523-4326

MSD Consumer Care, Inc. Coricidin HBP Chest Congestion And Cough 2 BLISTER PACK in 1 CARTON (11523-7158-2) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK

10 mg/1, 200 mg/1 Dextromethorphan hydrobromide and Guaifenesin

11523-7158

DOH 690-292 May 2016 228 of 379


Nash Finch Mucus Relief Cold, Flu and Sore Throat 177 mL in 1 BOTTLE, PLASTIC (70253-233-06)


Mucinex Fast Max Cold, Flu and Sore Throat Maximum Strength

70253-233

Nash-Finch Company Night Time Original 177 mL in 1 BOTTLE, PLASTIC (70253-112-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


70253-112

Nash-Finch Company Night Time Original 296 mL in 1 BOTTLE, PLASTIC (70253-112-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


70253-112

Nash-Finch Company Night Time Cherry 177 mL in 1 BOTTLE, PLASTIC (70253-113-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


70253-113

Nash-Finch Company Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (70253-113-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


70253-113

Nash-Finch Company Day Time 296 mL in 1 BOTTLE, PLASTIC (70253-142-01)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


70253-142

NASH-FINCH COMPANY Mucus Relief DM 1 BOTTLE, PLASTIC in 1 CARTON (70253-533-01) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC


70253-533

Nash-Finch Company Tussin DM 237 mL in 1 BOTTLE, PLASTIC (70253-018-08)


70253-018

N

DOH 690-292 May 2016 229 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCNash-Finch Company Tussin DM 118 mL in 1 BOTTLE, PLASTIC

(70253-018-04)10 mg/5mL, 100 mg/5mL Dextromethorphan


National Distribution Network (Smar Nighttime Cold and Flu 177 mL in 1 BOTTLE (53441-342-07) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


53441-342

National Distribution Network (Smar Nighttime Cold and Flu 237 mL in 1 BOTTLE, PLASTIC (53441-343-06)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


53441-343

National Distribution Network (Smar Night Time Cold and Flu 237 mL in 1 BOTTLE, PLASTIC (53441-344-08)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


53441-344

National Distribution Network (Smar Nighttime Cold and Flu 177 mL in 1 BOTTLE (53441-346-06) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


53441-346

National Distribution Network (Smar Day Time Cold and Flu 177 mL in 1 BOTTLE (53441-311-06) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


53441-311

National Distribution Network (Smar Day Time Cold and Flu 237 mL in 1 BOTTLE (53441-311-08) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


53441-311

Navarro Discount Pharmacies,LLC Day Time Gelcap 1 BLISTER PACK in 1 BOX (59970-077-12) > 12 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK


59970-077

DOH 690-292 May 2016 230 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCNew Genesis/Monticello Drug LLC Cold Preparation 237 mL in 1 BOTTLE, PLASTIC

(11868-311-08)325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11868-311

New Genesis/Monticello Drug LLC Cold Preparation 355 mL in 1 BOTTLE, PLASTIC (11868-311-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11868-311


325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11868-466


325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11868-466

Nivagen Pharmaceuticals, Inc. Niva-Hist DM 473 mL in 1 BOTTLE (75834-060-16) 4 mg/5mL, 7.5 mg/5mL, 15 mg/5mL

BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE

75834-060

Nivagen Pharmaceuticals, Inc. Nivanex DMX 60 TABLET in 1 BOTTLE (75834-040-60)

380 mg/1, 15 mg/1, 10 mg/1

GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

75834-040

DOH 690-292 May 2016 231 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCNorth Safety Products LLC Multi Symptom Cold 250 CARTON in 1 CARTON (0498-

1070-50) > 125 CARTON in 1 CARTON (0498-1070-25) > 50 PACKET in 1 CARTON (0498-1070-10) > 2 TABLET in 1 PACKET (0498-1070-01)

325 mg/1, 162 mg/1, 200 mg/1, 15 mg/1

Acetaminophen, Dextromethorphan, Phenylephrine, Guaifenesin

0498-1070

Novartis Consumer Health Theraflu 245.5 mL in 1 BOTTLE (0043-0461-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan HBr, Phenylepherine HCl

0043-0461

Novartis Consumer Health Theraflu 6 POWDER, FOR SOLUTION in 1 CARTON (0043-6257-06)

650 mg/1, 20 mg/1, 10 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE

0043-6257

Novartis Consumer Health Inc. Triaminic 1 BOTTLE in 1 CARTON (0067-8118-04) > 118 mL in 1 BOTTLE


0067-8118

Novartis Consumer Health, Inc. Triaminic 1 BOTTLE in 1 CARTON (0067-6394-04) > 118 mL in 1 BOTTLE

160 mg/5mL, 1 mg/5mL, 7.5 mg/5mL

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan

0067-6394


160 mg/5mL, 1 mg/5mL, 7.5 mg/5mL

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan

0067-6394

Novartis Consumer Health, Inc. Theraflu 3 BLISTER PACK in 1 CARTON (0067-6395-24) > 8 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephreine HCI

0067-6395



0067-8115



0067-6348

DOH 690-292 May 2016 232 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCNovartis Consumer Health, Inc. Theraflu 6 POWDER, FOR SOLUTION in 1

CARTON (0067-6427-06)1000 mg/1, 30 mg/1, 400 mg/1, 60 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl

0067-6427

Novartis Consumer Health, Inc. Theraflu 3 BLISTER PACK in 1 CARTON (0067-6396-24) > 8 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan HBr, Phenylephreine HCI

0067-6396

Novartis Consumer Health, Inc. THERAFLU 6 POWDER, FOR SOLUTION in 1 CARTON (0067-6426-06)

500 mg/1, 20 mg/1, 10 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl

0067-6426

Novartis Consumer Health, Inc. THERAFLU 12 POWDER, FOR SOLUTION in 1 CARTON (0067-6426-11)

500 mg/1, 20 mg/1, 10 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl

0067-6426

Novartis Consumer Health, Inc. COMTREX 2 BLISTER PACK in 1 CARTON (0067-2077-24) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 15 mg/1

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

0067-2077

Novartis Consumer Health, Inc. Theraflu ExpressMax 245.5 mL in 1 BOTTLE (0067-8127-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

0067-8127




0067-8116

Novartis Consumer Health, Inc. Triaminic Long Acting Cough 1 BOTTLE in 1 CARTON (0067-6350-04) > 118 mL in 1 BOTTLE

7.5 mg/5mL Dextromethorphan HBr 0067-6350

Novartis Consumer Health, Inc. Triaminic 1 BOTTLE, PLASTIC in 1 CARTON (0067-8105-04) > 118 mL in 1 BOTTLE, PLASTIC


0067-8105

DOH 690-292 May 2016 233 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCNovartis Consumer Health, Inc. Triaminic 1 BOTTLE, PLASTIC in 1 CARTON



0067-6345

Okendpharma, Inc. Rycontuss 473 mL in 1 BOTTLE (76117-001-16) 2 mg/5mL, 10 mg/5mL, 5 mg/5mL


76117-001

OUR FAMILY (Nash Finch Company) Nite Time Cold/Flu Relief 2 BLISTER PACK in 1 CARTON (70253-480-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

ACETAMINOHPEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE

70253-480

OUR FAMILY (Nash Finch Company) Day Time Cold/Flu Relief 2 BLISTER PACK in 1 CARTON (70253-470-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


70253-470

P & L Development, LLC Childrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (49580-0297-4) > 118 mL in 1 BOTTLE, PLASTIC



49580-0297

P & L Development, LLC Night time cold and flu 8 BLISTER PACK in 1 CARTON (59726-471-08) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59726-471

O

P

DOH 690-292 May 2016 234 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCP & L Development, LLC Nighttime Cold and Flu 237 mL in 1 BOTTLE, PLASTIC

(49580-0346-8)650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49580-0346

P & L Development, LLC Night Time Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (49580-0343-2)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49580-0343

P & L Development, LLC Night Time Cold and Flu 177 mL in 1 BOTTLE, PLASTIC (49580-0343-6)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49580-0343

P & L Development, LLC Severe cold and flu 237 mL in 1 BOTTLE, PLASTIC (49580-0416-8)


Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI

49580-0416

P & L Development, LLC Daytime Cold and Flu 296 mL in 1 BOTTLE, PLASTIC (49580-0466-1)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49580-0466

P & L Development, LLC Daytime Cold and Flu 177 mL in 1 BOTTLE, PLASTIC (49580-0466-6)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49580-0466

P & L Development, LLC Daytime Cold Flu 8 BLISTER PACK in 1 CARTON (59726-468-08) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


59726-468

DOH 690-292 May 2016 235 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCP & L Development, LLC Daytime Cold Flu 24 BLISTER PACK in 1 CARTON



59726-468

P & L Development, LLC Tussin Long Acting Cough 1 BOTTLE, PLASTIC in 1 BOX (49580-0383-4) > 118 mL in 1 BOTTLE, PLASTIC


P & L Development, LLC Tussin CF 1 BOTTLE, PLASTIC in 1 BOX (49580-0382-4) > 118 mL in 1 BOTTLE, PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49580-0382

P & L Development, LLC DayTime Cold and Cough 118 mL in 1 BOTTLE, PLASTIC (49580-0378-4)


49580-0378

P and L Development of New York CoCold and Flu Relief 24 BLISTER PACK in 1 CARTON (59726-029-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59726-029

P and L Development of New York CoMulti-Symptom Nitetime 8 BLISTER PACK in 1 BOX (59726-480-08) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


59726-480

P and L Development of New York CoMulti- Symptom Relief DayTime 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59726-470-08)


59726-470

P and L Development of New York CoMucus Relief DM 1 BOTTLE, PLASTIC in 1 BOX (59726-109-30) > 30 TABLET in 1 BOTTLE,PLASTIC


59726-109

P and L Development of New York CoMucus Relief DM 1 BOTTLE, PLASTIC in 1 BOX (59726-027-60) > 60 TABLET in 1 BOTTLE,PLASTIC


59726-027

DOH 690-292 May 2016 236 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPD-Rx Pharmaceuticals, Inc. GUAIFENESIN DM 90 TABLET in 1 BOTTLE, PLASTIC

(68752-012-90)400 mg/1, 20 mg/1 GUAIFENESIN

DEXTROMETHORPHAN68752-012

Perrigo New York Inc dextromethorphan polistirex extended release 1 BOTTLE in 1 CARTON (45802-433-21) > 89 mL in 1 BOTTLE


Perrigo New York Inc GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

1 BOTTLE in 1 CARTON (45802-735-66) > 14 TABLET, EXTENDEDRELEASE in 1 BOTTLE


45802-735

Pharma Associate Consultants, Inc Klernaz 30 TABLET in 1 BOTTLE (69140-620-03)

15 mg/1, 400 mg/1, 10 mg/1

Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

69140-620

Pharmaceutical Associates, Inc. GUAIFENESIN DM 10 TRAY in 1 CASE (0121-0638-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

100 mg/5mL, 10 mg/5mL GUAIFENESIN and DEXTROMETHORPHAN

0121-0638

Pharmaceutical Associates, Inc. GUAIFENESIN DM 10 TRAY in 1 CASE (0121-0638-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE


0121-0638

Pharmaceutical Associates, Inc. Guaifenesin DM 118 mL in 1 BOTTLE (0121-0809-04) 200 mg/5mL, 10 mg/5mL GUAIFENESIN and DEXTROMETHORPHAN

0121-0809

Pharmaceutical Associates, Inc. Guaifenesin DM 237 mL in 1 BOTTLE (0121-0809-08) 200 mg/5mL, 10 mg/5mL GUAIFENESIN and DEXTROMETHORPHAN

0121-0809

Pharmaceutical Associates, Inc. Guaifenesin DM 4 TRAY in 1 CASE (0121-4809-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE


0121-4809

Pharmaceutical Associates, Inc. Guaifenesin DM 4 TRAY in 1 CASE (0121-4809-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE


0121-4809

DOH 690-292 May 2016 237 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPharmadel LLC SanaTos Severe Cold and Cough Day Time 6 GRANULE, FOR SOLUTION in 1

CARTON (55758-010-06)650 mg/1, 20 mg/1, 10 mg/1


55758-010

Pharmadel LLC SanaTos Childrens Mucus Relief Cough 1 BOTTLE in 1 CARTON (55758-007-04) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

55758-007

Pharmalab Enterprises Inc Sanatos 177 mL in 1 BOTTLE, PLASTIC (14505-399-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


14505-399

Pharmalab Enterprises Inc Sanatos 177 mL in 1 BOTTLE, PLASTIC (14505-398-06)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine

14505-398

Pharmalab Enterprises Inc. Bisolvine 120 mL in 1 BOTTLE, PLASTIC (14505-488-04)

100 mg/5mL, 10 mg/5mL Guaifenesin, Dextromethorphan

14505-488

Physicians Total Care, Inc. Cold Head Congestion 2 BLISTER PACK in 1 CARTON (54868-6233-0) > 12 TABLET, FILM COATED in 1 BLISTER PACK


54868-6233

Physicians Total Care, Inc. Delsym 1 BOTTLE in 1 CARTON (54868-6003-0) > 89 mL in 1 BOTTLE


Physicians Total Care, Inc. Guaifenesin 473 mL in 1 BOTTLE, PLASTIC (54868-1986-0)


54868-1986

Physicians Total Care, Inc. Guaifenesin 118 mL in 1 BOTTLE, PLASTIC (54868-1986-1)


54868-1986

DOH 690-292 May 2016 238 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPhysicians Total Care, Inc. Tussin CF 1 BOTTLE in 1 CARTON (54868-6223-



54868-6223

Physicians Total Care, Inc. Tussin CF 1 BOTTLE in 1 CARTON (54868-6223-1) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


54868-6223

Physicians Total Care, Inc. Mucinex DM 2 BLISTER PACK in 1 CARTON (54868-5853-0) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK


54868-5853

Physicians Total Care, Inc. Mucinex DM 2 BLISTER PACK in 1 CARTON (54868-6106-0) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK


54868-6106

Physicians Total Care, Inc. Childrens Mucinex Cough 1 BOTTLE in 1 CARTON (54868-6125-0) > 118 mL in 1 BOTTLE


54868-6125

Physicians Total Care, Inc. Tussin DM 118 mL in 1 BOTTLE, PLASTIC (54868-1934-1)


54868-1934

Physicians Total Care, Inc. Tussin DM 237 mL in 1 BOTTLE, PLASTIC (54868-1934-2)


54868-1934

Poly Pharmaceuticals LORTUSS 12 BOTTLE in 1 TRAY (50991-598-15) > 15 mL in 1 BOTTLE

15 mg/5mL, 6.25 mg/5mL Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride

50991-598

DOH 690-292 May 2016 239 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPoly Pharmaceuticals LORTUSS 473 mL in 1 BOTTLE (50991-598-16) 15 mg/5mL, 6.25 mg/5mL Dextromethorphan

Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride

50991-598

Poly Pharmaceuticals DECONEX 60 CAPSULE in 1 BOTTLE (50991-583-60)

15 mg/1, 390 mg/1, 10 mg/1


50991-583

Poly Pharmaceuticals, Inc. Duraflu 100 TABLET, FILM COATED in 1 BOTTLE (50991-510-01)

500 mg/1, 20 mg/1, 200 mg/1, 60 mg/1


50991-510

Poly Pharmaceuticals, Inc. Duraflu 12 BLISTER PACK in 1 CARTON (50991-510-02) > 1 TABLET, FILM COATED in 1 BLISTER PACK

500 mg/1, 20 mg/1, 200 mg/1, 60 mg/1


50991-510

Poly Pharmaceuticals, Inc. Duraflu 100 TABLET in 1 BOTTLE (50991-535-01)

325 mg/1, 20 mg/1, 200 mg/1, 60 mg/1


50991-535

Poly Pharmaceuticals, Inc. ALAHIST 12 BOTTLE in 1 TRAY (50991-814-15) > 15 mL in 1 BOTTLE

4 mg/5mL, 7.5 mg/5mL, 15 mg/5mL


50991-814

Poly Pharmaceuticals, Inc. ALAHIST 473 mL in 1 BOTTLE (50991-814-16) 4 mg/5mL, 7.5 mg/5mL, 15 mg/5mL


50991-814

DOH 690-292 May 2016 240 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPoly Pharmaceuticals, Inc. DECONEX 12 BLISTER PACK in 1 CARTON

(50991-730-02) > 1 TABLET in 1 BLISTER PACK

15 mg/1, 380 mg/1, 10 mg/1


50991-730

Poly Pharmaceuticals, Inc. DECONEX 60 TABLET in 1 BOTTLE (50991-730-60)

15 mg/1, 380 mg/1, 10 mg/1


50991-730

Poly Pharmaceuticals, Inc. POLY-TUSSIN 473 mL in 1 BOTTLE (50991-320-16) 15 mg/5mL, 5 mg/5mL, 2 mg/5mL

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorpheniramine Maleate

50991-320

Poly Pharmaceuticals, Inc. Poly-Hist DM 6 BOTTLE in 1 TRAY (50991-220-15) > 15 mL in 1 BOTTLE


Dextromethorphan Hydrobromide, Phenylephrine HCl and Thonzylamine HCl

50991-220

Poly Pharmaceuticals, Inc. Poly-Hist DM 473 mL in 1 BOTTLE (50991-220-16) 10 mg/5mL, 5 mg/5mL, 25 mg/5mL

Dextromethorphan Hydrobromide, Phenylephrine HCl and Thonzylamine HCl

50991-220

Poly Pharmaceuticals, Inc. Poly-Vent DM 100 TABLET in 1 BOTTLE (50991-214-01)

380 mg/1, 20 mg/1, 60 mg/1

Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl

50991-214

Poly Pharmaceuticals, Inc. Poly-Vent DM 12 POUCH in 1 CARTON (50991-214-02) > 1 TABLET in 1 POUCH

380 mg/1, 20 mg/1, 60 mg/1

Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl

50991-214

Portal Inc. Brontuss 30 mL in 1 BOTTLE (49963-813-01) 15 mg/5mL, 300 mg/5mL, 10 mg/5mL


49963-813



49963-813

DOH 690-292 May 2016 241 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPortal Inc. Brontuss 118 mL in 1 BOTTLE (49963-913-04) 20 mg/5mL, 200 mg/5mL,

10 mg/5mLDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

49963-913



49963-913

Portal Pharmaceutical Bronkids 30 mL in 1 BOTTLE (49963-532-01) 4 mg/5mL, 10 mg/5mL, 10 mg/5mL


49963-532

Portal Pharmaceutical Bronkids 118 mL in 1 BOTTLE (49963-532-04) 4 mg/5mL, 10 mg/5mL, 10 mg/5mL


49963-532

Portal Pharmaceutical Bronkids 30 mL in 1 BOTTLE, PLASTIC (49963-210-01)


Chlorpheniramine/Dextromethorphan/Phenylephrine

49963-210

Portal Pharmaceutical Bronkids 118 mL in 1 BOTTLE, PLASTIC (49963-210-04)


Chlorpheniramine/Dextromethorphan/Phenylephrine

49963-210

Portal Pharmaceutical Bronkids 1 BOTTLE in 1 CARTON (49963-118-01) > 30 mL in 1 BOTTLE

.6 mg/mL, 1.5 mg/mL, 2.75 mg/mL


49963-118

Portal Pharmaceutical Brontuss 30 mL in 1 BOTTLE (49963-381-01) 15 mg/5mL, 300 mg/5mL, 10 mg/5mL


49963-381

Portal Pharmaceutical Brontuss 118 mL in 1 BOTTLE (49963-381-04) 15 mg/5mL, 300 mg/5mL, 10 mg/5mL


49963-381

DOH 690-292 May 2016 242 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPreferred Pharmaceuticals Inc. good sense tussin dm 118 mL in 1 BOTTLE (68788-0412-1) 20 mg/10mL, 200 mg/10mL Dextromethorphan HBr,


Preferred Pharmaceuticals, Inc Q-Tapp DM Elixir 118 mL in 1 BOTTLE, PLASTIC (68788-0852-0)


Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide

68788-0852

Preferred Pharmaceuticals, Inc Q Tussin DM 118 mL in 1 BOTTLE, PLASTIC (68788-9101-1)


68788-9101

Preferred Pharmaceuticals, Inc good sense tussin cf 118 mL in 1 BOTTLE (68788-9813-1) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


68788-9813

Preferred Pharmaceuticals, Inc Siltussin DM 118 mL in 1 BOTTLE, PLASTIC (68788-9103-1)


68788-9103

Preferred Pharmaceuticals, Inc. Pediatric Cough and Cold Medicine 118 mL in 1 BOTTLE, PLASTIC (68788-9769-1)



68788-9769

Preferred Pharmaceuticals, Inc. Mucus Relief DM 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-0839-2)


68788-0839



68788-0839



68788-0839

Preferred Pharmaceuticals, Inc. Diabetic Siltussin DM DAS-Na 118 mL in 1 BOTTLE, PLASTIC (68788-6760-1)


68788-6760

DOH 690-292 May 2016 243 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPreferred Plus (Kinray) Nite-Time Cold and Flu 2 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


61715-043

Preferred Plus (Kinray) Day Time Cold and Flu 2 BLISTER PACK in 1 CARTON (61715-042-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


61715-042

Premier Value Premier Value Multi-Symptom Severe Cold 6 GRANULE, FOR SOLUTION in 1 BOX (68016-754-06)

500 mg/1, 20 mg/1, 10 mg/1


68016-754

Prestige Brands Holdings, Inc. PediaCare Childrens MultiSymptom Cold 1 BOTTLE in 1 CARTON (52183-359-04) > 118 mL in 1 BOTTLE

5 mg/5mL, 2.5 mg/5mL Dextromethorphan HBr and Phenylephrine HCl

52183-359

Prestige Brands Holdings, Inc. Chloraseptic Sore Throat Liquid Center 1 BLISTER PACK in 1 CARTON (67172-015-11) > 15 LOZENGE in 1 BLISTER PACK

10 mg/1, 6 mg/1, 5 mg/1 Menthol and Benzocaine and Dextromethorphan Hydrobromide

67172-015

Prestige Brands Holdings, Inc. Chloraseptic Sore Throat Liquid Center 1 BLISTER PACK in 1 CARTON (67172-016-11) > 15 LOZENGE in 1 BLISTER PACK

10 mg/1, 6 mg/1, 5 mg/1 Menthol and Benzocaine and Dextromethorphan Hydrobromide

67172-016

Procter & Gamble Manufacturing Co Vicks Alcohol Free NyQuil 236 mL in 1 BOTTLE, PLASTIC (37000-699-08)

325 mg/15mL, 2 mg/15mL, 15 mg/15mL

Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide

37000-699


325 mg/15mL, 2 mg/15mL, 15 mg/15mL


37000-699

DOH 690-292 May 2016 244 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCProcter & Gamble Manufacturing Co Vicks Alcohol Free NyQuil 177 mL in 1 BOTTLE, PLASTIC

(37000-699-06)325 mg/15mL, 2 mg/15mL, 15 mg/15mL


37000-699


325 mg/15mL, 2 mg/15mL, 15 mg/15mL


37000-699

Procter & Gamble Manufacturing Co Vicks NyQuil 236 mL in 1 BOTTLE, PLASTIC (37000-808-08)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37000-808


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37000-808


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37000-809


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37000-809




37000-812

DOH 690-292 May 2016 245 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCProcter & Gamble Manufacturing Co Vicks NyQuil 354 mL in 1 BOTTLE, PLASTIC

(37000-812-12)650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


37000-812

Procter & Gamble Manufacturing Co Vicks NyQuil 2 BOTTLE, PLASTIC in 1 PACKAGE (37000-812-24) > 354 mL in 1 BOTTLE, PLASTIC



37000-812

Procter & Gamble Manufacturing Co Vicks NyQuil 3 BOTTLE, PLASTIC in 1 PACKAGE (37000-812-36) > 354 mL in 1 BOTTLE, PLASTIC



37000-812

Procter & Gamble Manufacturing Co Vicks DayQuil 236 mL in 1 BOTTLE, PLASTIC (37000-810-08)



37000-810




37000-810

DOH 690-292 May 2016 246 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCProcter & Gamble Manufacturing Co Vicks DayQuil 2 TABLET in 1 POUCH (37000-811-

02)325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37000-811

Procter & Gamble Manufacturing Co Vicks DayQuil 6 BLISTER PACK in 1 CARTON (37000-811-12) > 2 TABLET in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37000-811


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37000-811


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37000-811



37000-690



37000-690

DOH 690-292 May 2016 247 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCProductos Zapotol Corp. Multi-Symptom Relief 10 BLISTER PACK in 1 CARTON



59428-720

Proficient Rx LP Multi-Symptom Mapap Cold Formula 2 BLISTER PACK in 1 CARTON (63187-652-24) > 12 TABLET in 1 BLISTER PACK


63187-652

Proficient Rx LP Cough and Cold 2 BLISTER PACK in 1 CARTON (63187-689-16) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


63187-689

Proficient Rx LP Pedia Relief 120 mL in 1 BOTTLE, PLASTIC (63187-688-04)



63187-688

Proficient Rx LP Q Tussin DM 118 mL in 1 BOTTLE, PLASTIC (63187-040-04)


63187-040

Progela, S.A. de C.V. Cough and Cold 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (28623-250-01)

250 mg/1, 5 mg/1, 2 mg/1, 10 mg/1

Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride

28623-250

ProPhase Labs, Inc. Cold-EEZE 260 mL in 1 BOTTLE, UNIT-DOSE (61941-0300-1)



61941-0300

DOH 690-292 May 2016 248 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCProPhase Labs, Inc. Cold-EEZE 180 mL in 1 BOTTLE, UNIT-DOSE

(61941-0400-1)20 mg/5mL, 400 mg/5mL Dextromethorphan


ProPhase Labs, Inc. Kids-EEZE 72 PACKAGE in 1 CASE (61941-1003-1) > 12 TABLET, ORALLYDISINTEGRATING in 1 PACKAGE(61941-1003-6)

5 mg/1, 2.5 mg/1 Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

61941-1003

Publix Super Markets Inc nighttime cold 2 BLISTER PACK in 1 CARTON (56062-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


56062-393

Publix Super Markets Inc nighttime 355 mL in 1 BOTTLE (56062-459-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


56062-459

Publix Super Markets Inc NITETIME 296 mL in 1 BOTTLE (56062-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


56062-908

Publix Super Markets Inc nite time 6 BLISTER PACK in 1 CARTON (56062-977-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


56062-977


325 mg/1, 15 mg/1, 6.25 mg/1


56062-977

DOH 690-292 May 2016 249 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPublix Super Markets Inc nite time 12 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


56062-977


325 mg/1, 15 mg/1, 6.25 mg/1


56062-977

Publix Super Markets Inc Nighttime 296 mL in 1 BOTTLE (56062-335-38) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


56062-335

Publix Super Markets Inc Nighttime 355 mL in 1 BOTTLE (56062-335-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


56062-335

Publix Super Markets Inc Publix Cherry Flavor Nitetime 295 mL in 1 BOTTLE (56062-041-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


56062-041

Publix Super Markets Inc nitetime 12 BLISTER PACK in 1 CARTON (56062-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


56062-056

Publix Super Markets Inc nitetime 8 BLISTER PACK in 1 CARTON (56062-056-73) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


56062-056

DOH 690-292 May 2016 250 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPublix Super Markets Inc severe cold 12 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


56062-500

Publix Super Markets Inc severe cold 2 BLISTER PACK in 1 CARTON (56062-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


56062-234

Publix Super Markets Inc severe cold 2 BLISTER PACK in 1 CARTON (56062-308-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


56062-308

Publix Super Markets Inc severe cold and flu 12 BLISTER PACK in 1 CARTON (56062-319-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


56062-319

Publix Super Markets Inc Cold 2 BLISTER PACK in 1 CARTON (56062-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


56062-402

Publix Super Markets Inc cold relief 12 BLISTER PACK in 1 CARTON (56062-371-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan hbr, Phenylephrine hcl

56062-371

Publix Super Markets Inc daytime pe 1 BLISTER PACK in 1 CARTON (56062-215-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


56062-215

DOH 690-292 May 2016 251 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPublix Super Markets Inc daytime pe 2 BLISTER PACK in 1 CARTON



56062-215



56062-215



56062-994



56062-994



56062-994



56062-994

Publix Super Markets Inc day time 296 mL in 1 BOTTLE (56062-656-38) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


56062-656

Publix Super Markets Inc day time 355 mL in 1 BOTTLE (56062-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


56062-656

Publix Super Markets Inc Cold and Cough DM 1 BOTTLE in 1 CARTON (56062-987-26) > 118 mL in 1 BOTTLE



56062-987

DOH 690-292 May 2016 252 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPublix Super Markets Inc Cough DM 1 BOTTLE in 1 CARTON (56062-384-


Publix Super Markets Inc NIGHTTIME 296 mL in 1 BOTTLE (56062-668-38) 30 mg/30mL, 12.5 mg/30mL


56062-668

Publix Super Markets Inc NIGHTTIME 355 mL in 1 BOTTLE (56062-668-40) 30 mg/30mL, 12.5 mg/30mL


56062-668

Publix Super Markets Inc Tussin DM 1 BOTTLE in 1 CARTON (56062-359-26) > 118 mL in 1 BOTTLE


56062-359

Publix Super Markets Inc Tussin DM 1 BOTTLE in 1 CARTON (56062-359-34) > 237 mL in 1 BOTTLE


56062-359

Publix Super Markets Inc Tussin CF 1 BOTTLE in 1 CARTON (56062-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


56062-516

Publix Super Markets Inc Tussin CF 1 BOTTLE in 1 CARTON (56062-516-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


56062-516

PuraCap Pharmaceutical LLC NiteTime 1 BLISTER PACK in 1 CARTON (51013-106-01) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


51013-106

PuraCap Pharmaceutical LLC Maximum Strength Daytime Cold/Flu Relief 2 BLISTER PACK in 1 CARTON (51013-116-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI

51013-116

PuraCap Pharmaceutical LLC DayTime 1 BLISTER PACK in 1 CARTON (51013-105-01) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


51013-105

DOH 690-292 May 2016 253 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCPuraCap Pharmaceutical LLC DayTime Cold and Flu 1 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 5 mg/1 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

51013-134

PuraCap Pharmaceutical LLC. Maximum Strength Nighttime Cold/Flu Relief 2 BLISTER PACK in 1 CARTON (51013-110-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCI

51013-110

PuraVation Pharmaceuticals Inc NITE TIME COLD AND FLU 2 BLISTER PACK in 1 CARTON (76270-106-08) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


76270-106

Qualitest Pharmaceuticals Q Tapp Cold and Cough 1 BOTTLE, PLASTIC in 1 CARTON (0603-0852-54) > 118 mL in 1 BOTTLE, PLASTIC


Brompheniramine maleate and Dextromethorphan HBr and Pseudoephedrine HCl

0603-0852

Qualitest Pharmaceuticals Q Tapp Cold and Cough 118 mL in 1 BOTTLE, PLASTIC (0603-0852-94)


Brompheniramine maleate and Dextromethorphan HBr and Pseudoephedrine HCl

0603-0852

Qualitest Pharmaceuticals Q-Tapp DM Elixir 118 mL in 1 BOTTLE, PLASTIC (0603-0864-94)



0603-0864

Qualitest Pharmaceuticals Iophen DM NR 473 mL in 1 BOTTLE, PLASTIC (0603-1330-58)

10 mg/5mL, 100 mg/5mL dextromethorphan and guaifenesin

0603-1330

Q

DOH 690-292 May 2016 254 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCQualitest Pharmaceuticals Q Tussin DM 1 BOTTLE, PLASTIC in 1 CARTON



0603-0855

Qualitest Pharmaceuticals Q Tussin DM 1 BOTTLE, PLASTIC in 1 CARTON (0603-0855-56) > 237 mL in 1 BOTTLE, PLASTIC


0603-0855

Qualitest Pharmaceuticals Q Tussin DM 473 mL in 1 BOTTLE, PLASTIC (0603-0855-58)


0603-0855



0603-0855



0603-0855

Qualitest Pharmaceuticals Codituss DM 118 mL in 1 BOTTLE, PLASTIC (0603-0728-54)

10 mg/5mL, 5 mg/5mL, 8.33 mg/5mL

dextromethorphan hydrobromide and phenylephrine hydrochloride and pyrilamine maleate

0603-0728

Quality Choice Childrens Plus Multi-Symptom Cold Grape 118 mL in 1 BOTTLE, PLASTIC (63868-063-04)



63868-063

Quality Choice Night Time Cherry 177 mL in 1 BOTTLE, PLASTIC (63868-803-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL

NyQuil Cherry 63868-803

Quality Choice Night Time Cough Cherry 237 mL in 1 BOTTLE, PLASTIC (63868-807-08)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

Vicks NyQuil 63868-807

Quality Choice Night Time Cough Cherry 237 mL in 1 BOTTLE, PLASTIC (63868-807-12)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

Vicks NyQuil 63868-807

DOH 690-292 May 2016 255 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCQUALITY CHOICE (Chain Drug MarketMulti Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (63868-




63868-962

QUALITY CHOICE (Chain Drug MarketChildrens Multi-Symptom Cold Plus 1 BOTTLE, PLASTIC in 1 BOX (63868-374-04) > 118 mL in 1 BOTTLE,PLASTIC



63868-374

QUALITY CHOICE (Chain Drug MarketNighttime Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (63868-022-24) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


63868-022

QUALITY CHOICE (Chain Drug MarketCold and Cough 237 mL in 1 BOTTLE, PLASTIC (63868-065-08)

1000 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


63868-065

QUALITY CHOICE (Chain Drug MarketQuality Choice Nighttime Cold and Flu 1 BLISTER PACK in 1 BOX (63868-384-24) > 24 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


63868-384

QUALITY CHOICE (Chain Drug MarketCold and Flu 237 mL in 1 BOTTLE, PLASTIC (63868-140-08)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


63868-140

DOH 690-292 May 2016 256 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCQUALITY CHOICE (Chain Drug MarketCold and Flu 355 mL in 1 BOTTLE, PLASTIC

(63868-140-12)650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


63868-140

QUALITY CHOICE (Chain Drug MarketMucus Relief Cold Flu and Sore Throat 177 mL in 1 BOTTLE, PLASTIC (63868-746-07)



63868-746

QUALITY CHOICE (Chain Drug MarketDaytime Cold and Flu 237 mL in 1 BOTTLE, PLASTIC (63868-020-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


63868-020

QUALITY CHOICE (Chain Drug MarketDaytime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC (63868-020-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


63868-020

QUALITY CHOICE (Chain Drug MarketSevere Cold and Cough Relief 245 mL in 1 BOTTLE, PLASTIC (63868-021-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL


63868-021

QUALITY CHOICE (Chain Drug MarketDaytime 24 BLISTER PACK in 1 CARTON (63868-037-24) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


63868-037

QUALITY CHOICE (Chain Drug MarketDaytime Flu Relief Therapy 245 mL in 1 BOTTLE (63868-067-08) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


63868-067

QUALITY CHOICE (Chain Drug MarketQuality Choice Multi-Symptom, Non-Drowsy DayTime Cold and Flu

2 BLISTER PACK in 1 BOX (63868-386-24) > 24 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK


63868-386

DOH 690-292 May 2016 257 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCQUALITY CHOICE (Chain Drug MarketCold and Cough 1 BOTTLE, PLASTIC in 1 BOX (63868-


2 mg/10mL, 10 mg/10mL, 5 mg/10mL


63868-775

QUALITY CHOICE (Chain Drug MarketChildrens Dibromm Cold and Cough 1 BOTTLE in 1 BOX (63868-247-04) > 118 mL in 1 BOTTLE


Brompheniramine maleate, Phenylephrine HCl

63868-247

QUALITY CHOICE (Chain Drug MarketCough Relief 1 BOTTLE, PLASTIC in 1 BOX (63868-069-04) > 118 mL in 1 BOTTLE,PLASTIC


QUALITY CHOICE (Chain Drug MarketChildrens Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (63868-070-04) > 118 mL in 1 BOTTLE,PLASTIC


QUALITY CHOICE (Chain Drug MarketCough Relief 1 BOTTLE, PLASTIC in 1 BOX (63868-957-04) > 118 mL in 1 BOTTLE,PLASTIC


QUALITY CHOICE (Chain Drug MarketCough Relief 237 mL in 1 BOTTLE, PLASTIC (63868-808-08)

30 mg/30mL, 12.5 mg/30mL


63868-808

QUALITY CHOICE (Chain Drug MarketCough Relief 355 mL in 1 BOTTLE, PLASTIC (63868-237-12)

30 mg/30mL, 12.5 mg/30mL


63868-237

QUALITY CHOICE (Chain Drug MarketMucus Relief DM Max 177 mL in 1 BOTTLE, PLASTIC (63868-235-06)


63868-235

QUALITY CHOICE (Chain Drug MarketTussin DM 1 BOTTLE, PLASTIC in 1 BOX (63868-846-52) > 118 mL in 1 BOTTLE,PLASTIC


63868-846

QUALITY CHOICE (Chain Drug MarketTussin DM 1 BOTTLE, PLASTIC in 1 BOX (63868-855-52) > 118 mL in 1 BOTTLE,PLASTIC


63868-855

DOH 690-292 May 2016 258 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCQUALITY CHOICE (Chain Drug MarketTussin DM Cough and Chest Congestion 1 BOTTLE, PLASTIC in 1 BOX (63868-



63868-868

QUALITY CHOICE (Chain Drug MarketTussin DM Cough and Chest Congestion 1 BOTTLE, PLASTIC in 1 BOX (63868-868-56) > 237 mL in 1 BOTTLE,PLASTIC


63868-868

QUALITY CHOICE (Chain Drug MarketTussin CF 1 BOTTLE, PLASTIC in 1 BOX (63868-244-08) > 237 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


63868-244

QUALITY CHOICE (Chain Drug MarketMucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (63868-745-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


63868-745

QUALITY CHOICE (Chain Drug MarketTriacting Daytime Cold Cough 1 BOTTLE, PLASTIC in 1 BOX (63868-369-04) > 118 mL in 1 BOTTLE,PLASTIC


63868-369

Quality Home Products CVS day time cough and severe cold 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0543-6)

650 mg/1, 20 mg/1, 10 mg/1

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL.

64525-0543

Quality Home Products Our Family day time severe cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0545-6)

650 mg/1, 20 mg/1, 10 mg/1


64525-0545

Quality Home Products Premier Value day time severe cold and cough 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0547-6)

650 mg/1, 20 mg/1, 10 mg/1


64525-0547

Quality Home Products Quality Choice day time severe cold and cough 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0549-6)

650 mg/1, 20 mg/1, 10 mg/1


64525-0549

DOH 690-292 May 2016 259 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCQuality Home Products Rite Aid day time severe cold and cough 6 GRANULE, FOR SOLUTION in 1

BOX (64525-0551-6)650 mg/1, 20 mg/1, 10 mg/1


64525-0551

Quality Home Products TopCare day time severe cold and cough 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0553-6)

650 mg/1, 20 mg/1, 10 mg/1


64525-0553

Quality Home Products Meijer Daytime Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0555-6)

650 mg/1, 20 mg/1, 10 mg/1


64525-0555

Quality Home Products Best Choice Daytime Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0557-6)

650 mg/1, 20 mg/1, 10 mg/1


64525-0557

Quality Home Products Western Family Daytime Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0559-6)

650 mg/1, 20 mg/1, 10 mg/1


64525-0559

Quality Home Products Meijer Multi-Symptom Severe Cold 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0601-6)

500 mg/1, 20 mg/1, 10 mg/1


64525-0601

Quality Home Products Family Dollar Multi-Symptom Severe Cold 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0603-6)

500 mg/1, 20 mg/1, 10 mg/1


64525-0603

R. A. McNeil Company M-END 473 mL in 1 BOTTLE (12830-816-16) .667 mg/5mL, 10 mg/5mL, 20 mg/5mL

Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride

12830-816R

DOH 690-292 May 2016 260 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCR. A. McNeil Company M-END 30 mL in 1 BOTTLE (12830-816-30) .667 mg/5mL, 10 mg/5mL,

20 mg/5mLDexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride

12830-816

R.A. McNeil Company M-END 30 mL in 1 BOTTLE (12830-810-30) 2 mg/5mL, 15 mg/5mL, 15 mg/5mL

Chlorpheniramine Maleate, Dextromethorphan Hydrobromiede, and Pseudoephedrine Hydrochloride

12830-810

Rebel Distributors Corp Delsym 90 mL in 1 BOTTLE (21695-517-30) 30 mg/5mL Dextromethorphan Polistirex 21695-517Rebel Distributors Corp Delsym 90 mL in 1 BOTTLE (21695-518-30) 30 mg/5mL Dextromethorphan Polistirex 21695-518Rebel Distributors Corp Q Tussin DM 118 mL in 1 BOTTLE, PLASTIC

(21695-737-04)10 mg/5mL, 100 mg/5mL Dextromethorphan HBr and


Reckitt Benckiser Childrens Mucinex 12 PACKET in 1 CARTON (63824-256-12) > 1 GRANULE in 1 PACKET


63824-256

Reckitt Benckiser LLC Delsym Night Time 1 BOTTLE in 1 CARTON (63824-186-64) > 120 mL in 1 BOTTLE

325 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


63824-186

Reckitt Benckiser LLC Mucinex Fast-Max 2 BLISTER PACK in 1 CARTON (63824-593-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride

63824-593

DOH 690-292 May 2016 261 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Mucinex Fast-Max 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride

63824-591

Reckitt Benckiser LLC Childrens Mucinex 1 BOTTLE in 1 CARTON (63824-278-64) > 118 mL in 1 BOTTLE



63824-278

Reckitt Benckiser LLC Delsym 180 mL in 1 BOTTLE (63824-215-66) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


63824-215

Reckitt Benckiser LLC Childrens Delsym 180 mL in 1 BOTTLE (63824-216-66) 325 mg/10mL, 10 mg/10mL, 200 mg/10mL, 5 mg/10mL


63824-216

Reckitt Benckiser LLC Mucinex 4 POWDER, FOR SOLUTION in 1 CARTON (63824-231-04)

650 mg/1, 20 mg/1, 400 mg/1, 10 mg/1


63824-231

DOH 690-292 May 2016 262 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Mucinex 8 POWDER, FOR SOLUTION in 1

CARTON (63824-232-08)650 mg/1, 20 mg/1, 400 mg/1, 10 mg/1


63824-232

Reckitt Benckiser LLC Mucinex Fast-Max 2 BLISTER PACK in 1 CARTON (63824-196-20) > 10 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63824-196


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63824-196

Reckitt Benckiser LLC Mucinex 180 mL in 1 BOTTLE (63824-020-66) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


63824-020

Reckitt Benckiser LLC Mucinex Fast-Max 180 mL in 1 BOTTLE (63824-015-66) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


63824-015

DOH 690-292 May 2016 263 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Mucinex Fast-Max 266 mL in 1 BOTTLE (63824-015-69) 650 mg/20mL, 20

mg/20mL, 400 mg/20mL, 10 mg/20mL


63824-015




63824-017

Reckitt Benckiser LLC Delsym 8 POWDER, FOR SOLUTION in 1 CARTON (63824-112-08)

650 mg/1, 20 mg/1, 400 mg/1, 10 mg/1


63824-112

Reckitt Benckiser LLC Mucinex Sinus-Max 2 BLISTER PACK in 1 CARTON (63824-689-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine hydrochloride

63824-689



63824-592



63824-599

DOH 690-292 May 2016 264 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Cepacol 2 BLISTER PACK in 1 CARTON

(63824-741-16) > 8 LOZENGE in 1 BLISTER PACK

7.5 mg/1, 5 mg/1 Benzocaine and Dextromethorphan Hydrobromide

63824-741

Reckitt Benckiser LLC Cepacol 2 BLISTER PACK in 1 CARTON (63824-742-16) > 8 LOZENGE in 1 BLISTER PACK


63824-742



63824-742


7.5 mg/1, 5 mg/1 BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE

63824-743



63824-744



63824-744

Reckitt Benckiser LLC Delsym 2 CARTON in 1 CELLO PACK (63824-171-22) > 1 BOTTLE in 1 CARTON >148 mL in 1 BOTTLE


Reckitt Benckiser LLC Delsym 1 BOTTLE in 1 CARTON (63824-171-63) > 89 mL in 1 BOTTLE








DOH 690-292 May 2016 265 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Delsym 1 BOTTLE in 1 CARTON (63824-172-

65) > 148 mL in 1 BOTTLE30 mg/5mL Dextromethorphan 63824-172

Reckitt Benckiser LLC Delsym (Dextromethorphan) 1 BOTTLE in 1 CARTON (63824-173-63) > 89 mL in 1 BOTTLE




Reckitt Benckiser LLC Delsym 2 CARTON in 1 CELLO PACK (63824-175-22) > 1 BOTTLE in 1 CARTON >148 mL in 1 BOTTLE


















63824-286

Reckitt Benckiser LLC Mucinex Fast-Max 180 mL in 1 BOTTLE (63824-018-66) 20 mg/20mL, 400 mg/20mL dextromethorphan hydrobromide and guaifenesin

63824-018

DOH 690-292 May 2016 266 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Mucinex Fast-Max 180 mL in 1 BOTTLE (63824-019-66) 20 mg/20mL, 400 mg/20mL dextromethorphan

hydrobromide and guaifenesin63824-019

Reckitt Benckiser LLC Delsym 180 mL in 1 BOTTLE (63824-213-66) 20 mg/20mL, 400 mg/20mL Dextromethorphan Hydrobromide and Guaifenesin

63824-213

Reckitt Benckiser LLC Childrens Delsym 180 mL in 1 BOTTLE (63824-214-66) 5 mg/5mL, 100 mg/5mL Dextromethorphan Hydrobromide and Guaifenesin

63824-214


5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


63824-279

Reckitt Benckiser LLC Childrens Mucinex Multi-Symptom Cold 2 CARTON in 1 CELLO PACK (63824-282-22) > 1 BOTTLE in 1 CARTON >118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


63824-282

Reckitt Benckiser LLC Childrens Mucinex Multi-Symptom Cold 1 BOTTLE in 1 CARTON (63824-282-64) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


63824-282

Reckitt Benckiser LLC Childrens Mucinex Multi-Symptom Cold 1 BOTTLE in 1 CARTON (63824-282-67) > 201 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


63824-282

DOH 690-292 May 2016 267 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Childrens Mucinex 1 BOTTLE in 1 CARTON (63824-283-



63824-283

Reckitt Benckiser LLC Mucinex Fast-Max 2 BOTTLE in 1 CELLO PACK (63824-014-22) > 266 mL in 1 BOTTLE(63824-014-69)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


63824-014

Reckitt Benckiser LLC Mucinex Fast-Max 180 mL in 1 BOTTLE (63824-014-66) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


63824-014

Reckitt Benckiser LLC Mucinex Fast-Max 266 mL in 1 BOTTLE (63824-014-69) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


63824-014

Reckitt Benckiser LLC Delsym 16 LOZENGE in 1 BLISTER PACK (63824-160-16)

5 mg/1, 5 mg/1 Dextromethorphan Hydrobromide and Menthol

63824-160

Reckitt Benckiser LLC Delsym 16 LOZENGE in 1 BLISTER PACK (63824-161-16)

5 mg/1, 5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE and MENTHOL

63824-161

Reckitt Benckiser LLC Delsym 2 BLISTER PACK in 1 CARTON (63824-163-16) > 8 LOZENGE in 1 BLISTER PACK


63824-163

Reckitt Benckiser LLC Delsym 2 BLISTER PACK in 1 CARTON (63824-164-16) > 8 LOZENGE in 1 BLISTER PACK


63824-164

DOH 690-292 May 2016 268 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Mucinex DM 1 BLISTER PACK in 1 CARTON

(63824-056-32) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK


63824-056

Reckitt Benckiser LLC Mucinex DM 2 BLISTER PACK in 1 CARTON (63824-056-34) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK


63824-056



63824-056



63824-056

Reckitt Benckiser LLC Mucinex DM 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72)


63824-056

Reckitt Benckiser LLC Mucinex DM 24 POUCH in 1 CARTON (63824-056-74) > 2 TABLET, EXTENDED RELEASEin 1 POUCH (63824-056-73)


63824-056



63824-072

DOH 690-292 May 2016 269 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Mucinex DM 1 BLISTER PACK in 1 CARTON

(63824-072-35) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK


63824-072



63824-072



63824-072



63824-072

Reckitt Benckiser LLC Childrens Mucinex Cough 1 BOTTLE in 1 CARTON (63824-281-64) > 118 mL in 1 BOTTLE

100 mg/5mL, 5 mg/5mL GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE

63824-281

Reckitt Benckiser LLC Mucinex Fast-Max 16 POUCH in 1 CARTON (63824-191-16) > 2 TABLET, COATED in 1POUCH (63824-191-72)

200 mg/1, 5 mg/1, 325 mg/1, 10 mg/1

Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

63824-191


200 mg/1, 5 mg/1, 325 mg/1, 10 mg/1


63824-191

DOH 690-292 May 2016 270 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReckitt Benckiser LLC Mucinex Fast-Max 3 BLISTER PACK in 1 CARTON


200 mg/1, 5 mg/1, 325 mg/1, 10 mg/1


63824-191

Reckitt Benckiser LLC Mucinex Fast-Max 4 POUCH in 1 CARTON (63824-191-44) > 2 TABLET, COATED in 1POUCH (63824-191-72)

200 mg/1, 5 mg/1, 325 mg/1, 10 mg/1


63824-191

Reckitt Benckiser LLC Mucinex Fast-Max 2 TABLET, COATED in 1 POUCH (63824-191-72)

200 mg/1, 5 mg/1, 325 mg/1, 10 mg/1


63824-191


200 mg/1, 5 mg/1, 10 mg/1 Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

63824-193


200 mg/1, 5 mg/1, 10 mg/1 Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

63824-193

Reckitt Benckiser, Inc. Delsym 12 BOTTLE in 1 CARTON (63824-271-75) > 15 mL in 1 BOTTLE


Reese Pharmaceutical Co CVS Chest Congestion Relief 1 BOTTLE, PLASTIC in 1 CARTON (10956-003-01) > 30 TABLET in 1 BOTTLE, PLASTIC (10956-003-30)


10956-003



10956-003



10956-003

DOH 690-292 May 2016 271 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCReese Pharmaceutical Co Care One Chest Congestion Relief 1 BOTTLE, PLASTIC in 1 CARTON

(10956-014-01) > 50 TABLET in 1 BOTTLE, PLASTIC (10956-014-50)


10956-014

Reese Pharmaceutical Co Premier Value Chest Congestion and cough releif 1 BOTTLE, PLASTIC in 1 CARTON (10956-020-01) > 50 TABLET in 1 BOTTLE, PLASTIC (10956-020-11)


10956-020

Reese Pharmaceutical Co Double Tussin Intense Cough Reliever 1 BOTTLE, PLASTIC in 1 CARTON (10956-674-01) > 120 mL in 1 BOTTLE, PLASTIC (10956-674-04)


10956-674

Reese Pharmaceutical Co Double Tussin Intense Cough Reliever 240 mL in 1 BOTTLE, PLASTIC (10956-674-08)


10956-674

Reese Pharmaceutical Co Freds Chest Congestion Relief 1 BOTTLE, PLASTIC in 1 CARTON (10956-761-01) > 50 TABLET in 1 BOTTLE, PLASTIC (10956-761-50)


10956-761

RFX Pharmaceutical Co., Ltd. COUGH MEDICINE 6 BOTTLE, GLASS in 1 BOX (76206-002-01) > 10 mL in 1 BOTTLE, GLASS(76206-002-10)


RFX Pharmaceutical Co., Ltd. COUGH BE GONE 6 BOTTLE, GLASS in 1 BOX (76206-001-01) > 10 mL in 1 BOTTLE, GLASS(76206-001-10)

20 mg/10mL, 200 mg/10mL Dextromethorphan Hydrobromide Guaifenesin

76206-001

Richmond Division of Wyeth CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU



acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, phenylephrine HCl

0031-2246

Richmond Division of Wyeth ROBITUSSIN PEAK COLD NIGHTTIME COLD PLUS FLU 2 BLISTER PACK in 1 CARTON (0031-8722-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE

0031-8722

DOH 690-292 May 2016 272 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRichmond Division of Wyeth Robitussin Severe Multi-Symptom Cough Cold Flu 1 BOTTLE in 1 CARTON (0031-8751-

12) > 118 mL in 1 BOTTLE650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


0031-8751

Richmond Division of Wyeth Robitussin Severe Multi-Symptom Cough Cold Flu 1 BOTTLE in 1 CARTON (0031-8751-18) > 237 mL in 1 BOTTLE



0031-8751

Richmond Division of Wyeth ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU 30 POUCH in 1 CARTON (0031-8721-02) > 2 CAPSULE, LIQUID FILLED in 1POUCH


0031-8721

Richmond Division of Wyeth ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU 20 BLISTER PACK in 1 CARTON (0031-8721-20) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


0031-8721

Richmond Division of Wyeth CHILDRENS DIMETAPP COLD AND COUGH 1 BOTTLE in 1 CARTON (0031-2234-13) > 118 mL in 1 BOTTLE


brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl

0031-2234

Richmond Division of Wyeth CHILDRENS DIMETAPP COLD AND COUGH 1 BOTTLE in 1 CARTON (0031-2234-19) > 237 mL in 1 BOTTLE


brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl

0031-2234

Richmond Division of Wyeth CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD


1 mg/mL, 7.5 mg/5mL chlorpheniramine maleate, dextromethorphan HBr

0031-2238

Richmond Division of Wyeth Childrens Robitussin Nighttime Cough Long-Acting DM 1 BOTTLE in 1 CARTON (0031-8692-13) > 118 mL in 1 BOTTLE

2 mg/10mL, 15 mg/10mL chlorpheniramine maleate, dextromethorphan hydrobromide

0031-8692

DOH 690-292 May 2016 273 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRichmond Division of Wyeth CHILDRENS ROBITUSSIN COUGH AND COLD LONG-

ACTING1 BOTTLE in 1 CARTON (0031-8693-12) > 118 mL in 1 BOTTLE

1 mg/5mL, 7.5 mg/5mL chlorpheniramine maleate, dextrometrorphan HBr

0031-8693

Richmond Division of Wyeth Robitussin 12 Hour Cough Relief 1 BOTTLE in 1 CARTON (0031-8753-03) > 89 mL in 1 BOTTLE


Richmond Division of Wyeth Childrens Robitussin Cough Long-Acting 1 BOTTLE in 1 CARTON (0031-8694-12) > 118 mL in 1 BOTTLE

7.5 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE

0031-8694

Richmond Division of Wyeth Robitussin 12 Hour Cough Relief 1 BOTTLE in 1 CARTON (0031-8655-10) > 89 mL in 1 BOTTLE


Richmond Division of Wyeth ROBITUSSIN LINGERING COLD LONG-ACTING COUGH 1 BOTTLE in 1 CARTON (0031-8740-12) > 118 mL in 1 BOTTLE

15 mg/5mL dextromethorphan HBr 0031-8740

Richmond Division of Wyeth ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS

1 BOTTLE in 1 BLISTER PACK (0031-8741-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

15 mg/1 dextromethorphan hbr 0031-8741

Richmond Division of Wyeth Robitussin Maximum Strength Nighttime Cough DM 1 BOTTLE in 1 CARTON (0031-8717-12) > 118 mL in 1 BOTTLE

30 mg/10mL, 12.5 mg/10mL

DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE

0031-8717

Richmond Division of Wyeth Robitussin Maximum Strength Nighttime Cough DM 1 BOTTLE in 1 CARTON (0031-8717-18) > 237 mL in 1 BOTTLE

30 mg/10mL, 12.5 mg/10mL

DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE

0031-8717

Richmond Division of Wyeth Robitussin Maximum Strength Cough Plus Chest Congestion DM


10 mg/1, 200 mg/1 dextromethorphan hydrobromide and guaifenesin

0031-8719




0031-8719


500 POUCH in 1 BOX (0031-8719-70) > 2 CAPSULE, LIQUID FILLED in 1POUCH


0031-8719

DOH 690-292 May 2016 274 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRichmond Division of Wyeth Childrens Robitussin Cough and Chest Congestion DM 1 BOTTLE in 1 CARTON (0031-8715-

10) > 118 mL in 1 BOTTLE5 mg/5mL, 100 mg/5mL dextromethorphan

hydrobromide, guaifenesin0031-8715

Richmond Division of Wyeth ROBITUSSIN TO GO COUGH AND CHEST CONGESTION DM

10 POUCH in 1 BOX (0031-8712-10) > 10 VIAL, SINGLE-DOSE in 1 POUCH> 10 mL in 1 VIAL, SINGLE-DOSE

2 mg/mL, 20 mg/mL dextromethorphan HBr, guaifenesin

0031-8712

Richmond Division of Wyeth Robitussin Peak Cold Cough Plus Chest Congestion DM 1 BOTTLE in 1 CARTON (0031-8736-12) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL dextromethorphan hydrobromide and guaifenesin

0031-8736



0031-8736



0031-8736

Richmond Division of Wyeth Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM



0031-8737

Richmond Division of Wyeth Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM



0031-8737

Richmond Division of Wyeth ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM


20 mg/10mL, 400 mg/10mL dextromethorphan hydrobromide, guaifenesin

0031-8738




0031-8738




0031-8738

DOH 690-292 May 2016 275 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRichmond Division of Wyeth Robitussin Peak Cold Multi-Symptom Cold 1 BOTTLE in 1 CARTON (0031-8742-



0031-8742

Richmond Division of Wyeth Robitussin Peak Cold Multi-Symptom Cold 1 BOTTLE in 1 CARTON (0031-8742-20) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


0031-8742

Richmond Division of Wyeth ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD


10 mg/5mL, 200 mg/5mL, 5 mg/5mL


0031-8734

Richmond Division of Wyeth ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD


10 mg/5mL, 200 mg/5mL, 5 mg/5mL


0031-8734

Richmond Division of Wyeth ROBITUSSIN TO GO COUGH AND COLD CF 2 POUCH in 1 CARTON (0031-8713-02) > 1 VIAL, SINGLE-DOSE in 1POUCH > 10 mL in 1 VIAL, SINGLE-DOSE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


0031-8713

Richmond Division of Wyeth ROBITUSSIN TO GO COUGH AND COLD CF 10 POUCH in 1 CARTON (0031-8713-10) > 1 VIAL, SINGLE-DOSE in 1POUCH > 10 mL in 1 VIAL, SINGLE-DOSE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


0031-8713

Richmond Division of Wyeth Childrens Robitussin Cough and Cold CF 1 BOTTLE in 1 CARTON (0031-8716-12) > 118 mL in 1 BOTTLE

5 mg/5mL, 50 mg/5mL, 2.5 mg/5mL


0031-8716

DOH 690-292 May 2016 276 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRichmond Division of Wyeth Robitussin Medi-Soothers Cough DM 4 BLISTER PACK in 1 CARTON (0031-

8649-04) > 1 LOZENGE in 1 BLISTER PACK

5 mg/1, 5 mg/1 dextromethorphan hydrobromide and menthol

0031-8649

Richmond Division of Wyeth Robitussin Medi-Soothers Cough DM 4 BLISTER PACK in 1 CARTON (0031-8649-05) > 1 LOZENGE in 1 BLISTER PACK


0031-8649

Richmond Division of Wyeth Robitussin Medi-Soothers Cough DM 16 BLISTER PACK in 1 CARTON (0031-8649-16) > 1 LOZENGE in 1 BLISTER PACK


0031-8649

Rij Pharmaceutical Corporation Nite Time 177 mL in 1 BOTTLE, PLASTIC (53807-521-06)

325 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


53807-521

Rij Pharmaceutical Corporation Nite Time 177 mL in 1 BOTTLE, PLASTIC (53807-522-06)

325 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


53807-522

Rij Pharmaceutical Corporation Brom Tapp DM 118 mL in 1 BOTTLE (53807-530-04) 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL

brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl

53807-530

Rij Pharmaceutical Corporation Brom Tapp DM 236 mL in 1 BOTTLE (53807-530-08) 1 mg/5mL, 5 mg/5mL, 2.5 mg/5mL

brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl

53807-530

Rij Pharmaceutical Corporation Ritussin DM 118 mL in 1 BOTTLE (53807-409-04) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

53807-409

Rij Pharmaceutical Corporation Ritussin DM 236 mL in 1 BOTTLE (53807-409-08) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

53807-409

DOH 690-292 May 2016 277 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRij Pharmaceutical Corporation Ritussin DM 473 mL in 1 BOTTLE (53807-409-16) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN

HYDROBROMIDE and GUAIFENESIN

53807-409

Rij Pharmaceutical Corporation Ritussin DM 3785 mL in 1 BOTTLE (53807-409-28)

10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

53807-409

Rij Pharmaceutical Corporation Cough Formula Cough and Cold 118 mL in 1 BOTTLE (53807-531-04) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


53807-531

Rij Pharmaceutical Corporation Cough Formula Cough and Cold 236 mL in 1 BOTTLE (53807-531-08) 10 mg/5mL, 100 mg/5mL, 5 mg/5mL


53807-531

Rite Aid cold and flu relief hbp 2 BLISTER PACK in 1 CARTON (11822-4610-9) > 10 TABLET, FILM COATED in 1 BLISTER PACK


11822-4610

Rite Aid Childrens Plus Multi-Symptom Cold Grape 118 mL in 1 BOTTLE, PLASTIC (11822-1434-4)



11822-1434

Rite Aid Maximum Strength Flu 1 BLISTER PACK in 1 CARTON (11822-0461-9) > 20 TABLET, FILM COATED in 1 BLISTER PACK


11822-0461

Rite Aid Night Time Cherry 355 mL in 1 BOTTLE, PLASTIC (11822-1403-2)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11822-1403

Rite Aid Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (11822-1403-1)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11822-1403

DOH 690-292 May 2016 278 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Night Time Original 177 mL in 1 BOTTLE, PLASTIC

(11822-1406-6)500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11822-1406

Rite Aid Night Time Original 296 mL in 1 BOTTLE, PLASTIC (11822-1406-1)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11822-1406

Rite Aid Night Time 177 mL in 1 BOTTLE, PLASTIC (11822-0403-6)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11822-0403

Rite Aid cold and cough sinus relief PE 2 BLISTER PACK in 1 CARTON (11822-0546-9) > 20 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1

Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl

11822-0546

Rite Aid Mucus Relief Severe Congestion and Cold Max 2 BLISTER PACK in 1 PACKAGE (11822-0617-9) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-0617

Rite Aid head congestion and cold relief 1 BLISTER PACK in 1 CARTON (11822-0503-8) > 24 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-0503

Rite Aid cold relief 2 BLISTER PACK in 1 CARTON (11822-5030-8) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-5030

DOH 690-292 May 2016 279 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Cold and Flu 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-5031

Rite Aid Mucus Relief Cold Flu and Sore Throat Max 2 BLISTER PACK in 1 PACKAGE (11822-6160-9) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-6160

Rite Aid Mucus Relief Plus 1 BOTTLE in 1 CARTON (11822-3720-1) > 30 TABLET, FILM COATED in 1BOTTLE

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-3720

Rite Aid Flu Relief Therapy Day Time 245 mL in 1 BOTTLE, PLASTIC (11822-2104-8)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride

11822-2104

Rite Aid Day Time 296 mL in 1 BOTTLE, PLASTIC (11822-3416-1)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCI

11822-3416

Rite Aid Multi-Symptom Daytime Cold 1 BLISTER PACK in 1 CARTON (11822-0560-2) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr

11822-0560

Rite Aid Long Acting Tussin Cough Gels 1 BOTTLE in 1 PACKAGE (11822-0442-9) > 20 CAPSULE, GELATIN COATED in 1 BOTTLE


Rite Aid Night Time Cough Cherry 177 mL in 1 BOTTLE, PLASTIC (11822-0402-6)


11822-0402

DOH 690-292 May 2016 280 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Mucus Relief Cough and Congestion DM 1 BOTTLE, PLASTIC in 1 CARTON

(11822-5330-0) > 30 TABLET, COATED in 1 BOTTLE, PLASTIC

20 mg/1, 400 mg/1 Guaifenesin and Dextromethorphan HBr

11822-5330

Rite Aid Mucus Relief Cough and Congestion DM 1 BOTTLE, PLASTIC in 1 CARTON (11822-5330-1) > 60 TABLET, COATED in 1 BOTTLE, PLASTIC


11822-5330

Rite Aid Tussin DM 237 mL in 1 BOTTLE, PLASTIC (11822-0408-8)


11822-0408

Rite Aid Tussin DM 118 mL in 1 BOTTLE, PLASTIC (11822-0408-4)


11822-0408

Rite Aid Tussin Cough and Chest Congestion DM 355 mL in 1 BOTTLE, PLASTIC (11822-0018-2)

10 mg/5mL, 100 mg/5mL Robitussin DM 11822-0018


10 mg/5mL, 100 mg/5mL Robitussin DM 11822-0018


10 mg/5mL, 100 mg/5mL Robitussin Sugar Free Cough 11822-0100

Rite Aid Tussin CF 118 mL in 1 BOTTLE, PLASTIC (11822-0126-4)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


Rite Aid Corporation Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (11822-5047-2) > 118 mL in 1 BOTTLE, PLASTIC



11822-5047

Rite Aid Corporation nighttime cold and flu relief 355 mL in 1 BOTTLE (11822-0459-1) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


11822-0459



11822-0459

DOH 690-292 May 2016 281 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Corporation nighttime cold and flu relief 2 BOTTLE in 1 PACKAGE (11822-

0459-3) > 355 mL in 1 BOTTLE650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


11822-0459

Rite Aid Corporation nighttime cold and flu relief 12 BLISTER PACK in 1 CARTON (11822-0977-1) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11822-0977

Rite Aid Corporation nighttime cold and flu relief 24 BLISTER PACK in 1 CARTON (11822-0977-2) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11822-0977

Rite Aid Corporation Nite Time Cold and Flu 296 mL in 1 BOTTLE (11822-0041-1) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11822-0041



11822-0041



11822-0041

Rite Aid Corporation nighttime cold and flu relief 12 BLISTER PACK in 1 CARTON (11822-0056-1) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11822-0056

Rite Aid Corporation nighttime cold and flu relief 24 BLISTER PACK in 1 CARTON (11822-0056-2) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11822-0056

DOH 690-292 May 2016 282 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Corporation nighttime cold and flu relief 237 mL in 1 BOTTLE (11822-0335-1) 650 mg/30mL, 30


11822-0335



11822-0335

Rite Aid Corporation nighttime cold and flu relief 2 BOTTLE in 1 PACKAGE (11822-0335-3) > 355 mL in 1 BOTTLE

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


11822-0335

Rite Aid Corporation severe cold and flu relief 12 BLISTER PACK in 1 CARTON (11822-0805-1) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


11822-0805

Rite Aid Corporation nighttime severe cold and flu relief 355 mL in 1 BOTTLE (11822-0511-1) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


11822-0511

Rite Aid Corporation severe cold and flu relief 355 mL in 1 BOTTLE (11822-0763-1) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


11822-0763

Rite Aid Corporation daytime severe cold and flu relief 12 BLISTER PACK in 1 CARTON (11822-0548-1) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-0548

Rite Aid Corporation daytime cold relief 2 BLISTER PACK in 1 CARTON (11822-0308-1) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11822-0308

DOH 690-292 May 2016 283 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Corporation Daytime Severe Cold and Flu Relief 355 mL in 1 BOTTLE (11822-0710-1) 325 mg/15mL, 10

mg/15mL, 200 mg/15mL, 5 mg/15mL


11822-0710

Rite Aid Corporation cold and flu relief 12 BLISTER PACK in 1 CARTON (11822-0994-1) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11822-0994

Rite Aid Corporation cold and flu relief 24 BLISTER PACK in 1 CARTON (11822-0994-2) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11822-0994

Rite Aid Corporation Rite Aid Daytime Severe Cold and Cough Relief 6 POWDER, FOR SOLUTION in 1 CARTON (11822-2112-7)

650 mg/1, 20 mg/1, 10 mg/1


11822-2112

Rite Aid Corporation daytime cold and flu relief 237 mL in 1 BOTTLE (11822-0656-1) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11822-0656

Rite Aid Corporation daytime cold and flu relief 355 mL in 1 BOTTLE (11822-0656-2) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11822-0656

Rite Aid Corporation severe cold cough and flu relief 6 POWDER, FOR SOLUTION in 1 CARTON (11822-0096-1)

650 mg/1, 20 mg/1, 10 mg/1


11822-0096

Rite Aid Corporation Tussin Long Acting Cough 1 BOTTLE in 1 CARTON (11822-0493-1) > 118 mL in 1 BOTTLE


11822-0493

Rite Aid Corporation Cough DM 1 BOTTLE in 1 CARTON (11822-0494-1) > 89 mL in 1 BOTTLE




DOH 690-292 May 2016 284 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Corporation Cough DM 1 BOTTLE in 1 CARTON (11822-0384-




Rite Aid Corporation nighttime cough relief 237 mL in 1 BOTTLE (11822-0668-1) 30 mg/30mL, 12.5 mg/30mL


11822-0668

Rite Aid Corporation nighttime cough relief 355 mL in 1 BOTTLE (11822-0668-2) 30 mg/30mL, 12.5 mg/30mL


11822-0668

Rite Aid Corporation cough and chest congestion dm max 1 BOTTLE in 1 CARTON (11822-0799-1) > 118 mL in 1 BOTTLE


11822-0799

Rite Aid Corporation cough and chest congestion dm max 1 BOTTLE in 1 CARTON (11822-0799-2) > 237 mL in 1 BOTTLE


11822-0799

Rite Aid Corporation Cough and Chest Congestion DM 1 BOTTLE in 1 CARTON (11822-0359-1) > 118 mL in 1 BOTTLE


11822-0359



11822-0359



11822-0359

Rite Aid Corporation Cough 1 BOTTLE in 1 CARTON (11822-0419-1) > 118 mL in 1 BOTTLE


11822-0419

Rite Aid Corporation Multi Symptom Cold CF 1 BOTTLE in 1 CARTON (11822-0296-1) > 118 mL in 1 BOTTLE

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


11822-0296


20 mg/10mL, 400 mg/10mL, 10 mg/10mL


11822-0296


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


11822-0669

DOH 690-292 May 2016 285 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRite Aid Corporation Multi Symptom Cold CF 1 BOTTLE in 1 CARTON (11822-0669-



11822-0669

Rite Aid Corporation Adult Tussin Cough and Cold CF 1 BOTTLE in 1 CARTON (11822-0516-1) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


11822-0516


10 mg/5mL, 100 mg/5mL, 5 mg/5mL


11822-0516


10 mg/5mL, 100 mg/5mL, 5 mg/5mL


11822-0516

Rite Aid Corporation childrens mucus relief multi symptom cold 1 BOTTLE in 1 CARTON (11822-0839-1) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


11822-0839

Robinson Pharma, Inc. NightTime Cold and Flu 2 BLISTER PACK in 1 BOX (59995-001-12) > 12 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

ACETAMINOPHEN, DOXYLAMINE SUCCINATE HCL, DEXTROMETHORPHAN HYDROBROMIDE

59995-001

Robinson Pharma, Inc. Non-Drowsy DayTime Cold and Flu Multi-Symptom Relief

2 BLISTER PACK in 1 BOX (59995-002-12) > 12 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBr

59995-002

RockHealth, Inc Libera Tos 118 mL in 1 BOTTLE (60840-0100-1) 10 mg/5mL, 100 mg/5mL Dextromethorphan HBr, Guaifenesin

60840-0100


60840-0100


60840-0200

DOH 690-292 May 2016 286 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCRockHealth, Inc Libera Tos 178 mL in 1 BOTTLE (60840-0200-2) 10 mg/5mL, 100 mg/5mL Dextromethorphan HBr,



60840-0300


60840-0300

Rugby Laboratories Sore Throat and Cough 1 BLISTER PACK in 1 CARTON (0536-1045-21) > 18 LOZENGE in 1 BLISTER PACK

7.5 mg/1, 5 mg/1 benzocaine and dextromethorphan hydrobromide

0536-1045

Rugby Laboratories Robafen Cough 1 BOTTLE in 1 PACKAGE (0536-1068-34) > 20 CAPSULE, LIQUID FILLED in1 BOTTLE


Rugby Laboratories Inc. Extra action Cough 473 mL in 1 BOTTLE (0536-0970-85) 100 mg/5mL, 10 mg/5mL Guaifenesin and DEXTROMETHORPHAN HYDROBROMIDE

0536-0970

Rugby Laboratories Inc. Extra action Cough 118 mL in 1 BOTTLE (0536-0970-97) 100 mg/5mL, 10 mg/5mL Guaifenesin and DEXTROMETHORPHAN HYDROBROMIDE

0536-0970

Rugby Laboratories, Inc. Kidkare 118 mL in 1 BOTTLE (0536-2310-97) 1 mg/5mL, 5 mg/5mL, 15 mg/5mL

Chlorpheniramine, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride

0536-2310

Safeway Night Time Cherry 296 mL in 1 BOTTLE, PLASTIC (21130-113-01)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


21130-113S

DOH 690-292 May 2016 287 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSafeway Signature Care Nighttime Severe Cold and Flu Relief 355 mL in 1 BOTTLE (21130-129-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


21130-129

Safeway Night Time Cold and Flu 296 mL in 1 BOTTLE (21130-609-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL


21130-609

Safeway Signature Care Non drowsy Daytime Severe Cold and Flu Relief



21130-091

Safeway Flu and Severe Cold and Cough 6 POWDER, FOR SOLUTION in 1 CARTON (21130-096-91)

650 mg/1, 20 mg/1, 10 mg/1


21130-096

Safeway Signature Care Childrens Cold and Cough 1 BOTTLE in 1 CARTON (21130-082-26) > 118 mL in 1 BOTTLE



21130-082

Safeway Cough and Cold HBP 2 BLISTER PACK in 1 CARTON (21130-411-21) > 8 TABLET in 1 BLISTER PACK


21130-411

Safeway Signature Care Daytime Cough 355 mL in 1 BOTTLE (21130-635-40) 15 mg/15mL Dextromethorphan HBr 21130-635

Safeway Cough Relief 1 BOTTLE in 1 CARTON (21130-402-21) > 89 mL in 1 BOTTLE


Safeway day time cough 296 mL in 1 BOTTLE (21130-473-38) 15 mg/15mL Dextromethorphan HBr 21130-473

DOH 690-292 May 2016 288 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSafeway day time cough 355 mL in 1 BOTTLE (21130-473-40) 15 mg/15mL Dextromethorphan HBr 21130-473

Safeway cough dm 1 BOTTLE in 1 CARTON (21130-384-21) > 89 mL in 1 BOTTLE


Safeway Cough Relief 118 mL in 1 BOTTLE, PLASTIC (21130-156-04)


21130-156

Safeway signature care cough dm 1 BOTTLE in 1 CARTON (21130-200-21) > 89 mL in 1 BOTTLE


Safeway signature care 12 hour cough relief 1 BOTTLE in 1 CARTON (21130-012-21) > 89 mL in 1 BOTTLE


Safeway Cough DM 1 BOTTLE in 1 CARTON (21130-958-21) > 89 mL in 1 BOTTLE


Safeway Signature Care Tussin 1 BOTTLE in 1 CARTON (21130-799-34) > 237 mL in 1 BOTTLE


21130-799

Safeway Severe Congestion and Cough Relief 177 mL in 1 BOTTLE (21130-817-58) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


21130-817

Safeway, Inc. Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (21130-034-04) > 118 mL in 1 BOTTLE,PLASTIC



21130-034

Safeway, Inc. Nighttime Cold and Flu Relief 237 mL in 1 BOTTLE, PLASTIC (21130-044-08)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


21130-044

DOH 690-292 May 2016 289 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSafeway, Inc. Nighttime Cold and Flu Relief 355 mL in 1 BOTTLE (21130-044-12) 650 mg/30mL, 30

mg/30mL, 12.5 mg/30mLAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

21130-044

Safeway, Inc. Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (21130-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


21130-071

Safeway, Inc. Nighttime Cold and Flu Relief 237 mL in 1 BOTTLE, PLASTIC (21130-343-08)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


21130-343

Safeway, Inc. Nighttime Cold and Flu Relief 355 mL in 1 BOTTLE (21130-343-12) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


21130-343

Safeway, Inc. Nighttime Cold and Flu Relief 2 BOTTLE, PLASTIC in 1 PACKAGE (21130-343-24) > 355 mL in 1 BOTTLE, PLASTIC

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


21130-343

Safeway, Inc. Safeway Nighttime Cold and Flu 1 BLISTER PACK in 1 BOX (21130-480-24) > 24 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


21130-480

Safeway, Inc. Cold Flu and Sore Throat Relief 177 mL in 1 BOTTLE (21130-036-06) 650 mg/20mL, 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


21130-036

DOH 690-292 May 2016 290 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSafeway, Inc. Daytime Cold and Flu Relief 355 mL in 1 BOTTLE (21130-311-12) 325 mg/15mL, 10

mg/15mL, 5 mg/15mLAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

21130-311

Safeway, Inc. Day time 24 BLISTER PACK in 1 CARTON (21130-468-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


21130-468

Safeway, Inc. Safeway Daytime Cold and Flu Relief 2 BLISTER PACK in 1 BOX (21130-470-24) > 24 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK


21130-470

Safeway, Inc. Daytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (21130-471-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


21130-471

Safeway, Inc. Day Time Cold and Flu Relief 237 mL in 1 BOTTLE, PLASTIC (21130-866-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


21130-866

Safeway, Inc. Day Time Cold and Flu Relief 355 mL in 1 BOTTLE, PLASTIC (21130-866-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


21130-866

Safeway, Inc. Cold and Flu 24 BLISTER PACK in 1 CARTON (21130-868-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


21130-868

DOH 690-292 May 2016 291 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSafeway, Inc. Adult Cough Relief DM 1 BOTTLE, PLASTIC in 1 BOX (21130-



Safeway, Inc. Night Time Cough 355 mL in 1 BOTTLE, PLASTIC (21130-345-12)

30 mg/30mL, 12.5 mg/30mL


21130-345

Safeway, Inc. Adult Cough and Chest Congestion Relief DM 1 BOTTLE, PLASTIC in 1 BOX (21130-385-04) > 118 mL in 1 BOTTLE,PLASTIC


21130-385

Safeway, Inc. Adult Cough and Chest Congestion Relief DM 1 BOTTLE, PLASTIC in 1 BOX (21130-385-08) > 237 mL in 1 BOTTLE,PLASTIC


21130-385

Safeway, Inc. DM Max Relief 177 mL in 1 BOTTLE (21130-338-06) 20 mg/20mL, 400 mg/20mL dextromethorphan hydrobromide, guaifenesin

21130-338

Safeway, Inc. Childrens Mucus Relief DM 1 BOTTLE, PLASTIC in 1 BOX (21130-024-04) > 118 mL in 1 BOTTLE,PLASTIC


21130-024

Safeway, Inc. Multi Symptom Cold Relief CF 1 BOTTLE, PLASTIC in 1 BOX (21130-382-04) > 118 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


21130-382

Safeway, Inc. Triacting Day Time 118 mL in 1 BOTTLE, PLASTIC (21130-148-04)

5 mg/5mL, 2.5 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

21130-148

Safeway, Inc. Triacting Daytime Cold Cough 1 BOTTLE, PLASTIC in 1 BOX (21130-378-04) > 118 mL in 1 BOTTLE,PLASTIC


21130-378

DOH 690-292 May 2016 292 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSalado Sales, Inc. Nite-Time 177 mL in 1 BOTTLE (57243-501-25) 650 mg/30mL, 30


57243-501

Salado Sales, Inc. Nite-TimeCOLD/FLU CHERRY 177 mL in 1 BOTTLE (57243-502-25) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


57243-502

Salado Sales, Inc. NightTime Multi-Symptom Flu Cold 1 BLISTER PACK in 1 CARTON (57243-535-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


57243-535

Salado Sales, Inc. Night Time 2 BLISTER PACK in 1 CARTON (57243-660-02) > 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


57243-660

Salado Sales, Inc. Cold-Flu Relief 1 BLISTER PACK in 1 CARTON (57243-560-02) > 12 TABLET in 1 BLISTER PACK


57243-560

Salado Sales, Inc. Day Time 1 BLISTER PACK in 1 CARTON (57243-659-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


57243-659

Salado Sales, Inc. Daytime 177 mL in 1 BOTTLE (57243-506-25) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


57243-506

Salado Sales, Inc. DayTime Multi-Symptom Flu Cold Medicine 12 BLISTER PACK in 1 CARTON (57243-534-02) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


57243-534

DOH 690-292 May 2016 293 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSalado Sales, Inc. TUSSIN COUGH 118 mL in 1 BOTTLE (57243-503-24) 10 mg/5mL, 100 mg/5mL DEXTROMETHORPHAN


57243-503

Sallus Laboratories, LLC LORTUSS 473 mL in 1 BOTTLE (69036-120-16) 15 mg/5mL, 6.25 mg/5mL, 30 mg/5mL

Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride

69036-120

Sam's West Inc simply right Night Time 355 mL in 1 BOTTLE (68196-041-40) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


68196-041

Sam's West Inc simply right night time 355 mL in 1 BOTTLE (68196-872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


68196-872

SAMSUNG PHARM IND. CO., LTD. ALLPANTO S 488 mg in 1 BLISTER PACK (49789-010-01)

162.5 mg/448mg, 15 mg/448mg, 7.5 mg/448mg, 1 mg/448mg

ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE

49789-010

SAMSUNG PHARM IND. CO., LTD. CAREPANTO 630 mg in 1 BLISTER PACK (49789-030-01)

15 mg/630mg, 3 mg/630mg

DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE

49789-030

SAMSUNG PHARM IND. CO., LTD. Panto Flu 16999 mg in 1 CELLO PACK (49789-070-01)

15 mg/16999mg, 2.5 mg/16999mg

DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE

49789-070

DOH 690-292 May 2016 294 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSato Pharmaceutical Co., Ltd. Stona for Children 1 BOTTLE in 1 CARTON (49873-108-


acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide

49873-108

Sato Pharmaceutical Co., Ltd. Stona-S 1 BOTTLE in 1 CARTON (49873-113-01) > 24 CAPSULE in 1 BOTTLE

162.5 mg/1, 2 mg/1, 10 mg/1, 5 mg/1

acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

49873-113

Sato Pharmaceutical Co., Ltd. Stona 1 BOTTLE in 1 CARTON (49873-114-01) > 24 TABLET in 1 BOTTLE

162.5 mg/1, 2 mg/1, 10 mg/1, 5 mg/1

acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

49873-114

Sato Pharmaceutical Co., Ltd. Stona 1 BLISTER PACK in 1 CARTON (49873-301-01) > 12 LOZENGE in 1 BLISTER PACK

10 mg/1 dextromethorphan hydrobromide

49873-301

Sato Pharmaceutical Co., Ltd. Stona Cough 1 BOTTLE in 1 CARTON (49873-302-01) > 120 mL in 1 BOTTLE


49873-302

Sato Pharmaceutical Co., Ltd. Stona Cough 1 BOTTLE in 1 CARTON (49873-306-01) > 24 TABLET in 1 BOTTLE

15 mg/1, 100 mg/1, 5 mg/1 dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

49873-306

Save-A-Lot Food Stores Ltd being well night time cold and flu 237 mL in 1 BOTTLE (46994-150-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


46994-150

Save-A-Lot Food Stores Ltd being well cold and flu relief pm 177 mL in 1 BOTTLE (46994-335-30) 325 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


46994-335

DOH 690-292 May 2016 295 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSave-A-Lot Food Stores Ltd being well cold and flu relief pm 237 mL in 1 BOTTLE (46994-335-34) 325 mg/15mL, 15


46994-335

Save-A-Lot Food Stores Ltd being well cold flu relief 177 mL in 1 BOTTLE (46994-908-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


46994-908

Save-A-Lot Food Stores Ltd Being Well Adult Cough Relief DM 1 BOTTLE in 1 CARTON (46994-359-26) > 118 mL in 1 BOTTLE


46994-359

SCOT-TUSSIN Pharmacal Co., Inc. Scot-Tussin Diabetes Cough Formula with DM 118 mL in 1 BOTTLE (0372-0043-04) 10 mg/5mL dextromethorphan hydrobromide

0372-0043

SCOT-TUSSIN Pharmacal Co., Inc. Scot-Tussin 118 mL in 1 BOTTLE (0372-0036-04) 15 mg/5mL, 2 mg/5mL Dextromethorphan Hydrobromide Chlorpheniramine Maleate

0372-0036

SCOT-TUSSIN Pharmacal Co., Inc. Scot-Tussin Senior SF DMEXP 118 mL in 1 BOTTLE (0372-0050-04) 15 mg/5mL, 200 mg/5mL Dextromethorphan Hydrobromide, Guaifenesin

0372-0050

Selder, S.A. de C.V. Cough and Cold 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-20)

250 mg/1, 5 mg/1, 2 mg/1, 10 mg/1


63654-800

Select Brand Night Time Original 296 mL in 1 BOTTLE, PLASTIC (15127-980-10)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


15127-980

DOH 690-292 May 2016 296 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSelect Brand Severe Cold and Flu 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


15127-184

Select Brand Cough Relief 118 mL in 1 BOTTLE, PLASTIC (15127-925-04)

15 mg/5mL Delsym 15127-925

Select Brand Tussin CF 118 mL in 1 BOTTLE, PLASTIC (15127-943-04)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


Select Brand Dist. Childrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (15127-950-04) > 118 mL in 1 BOTTLE,PLASTIC



15127-950

Select Brand Dist. Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (15127-931-04) > 118 mL in 1 BOTTLE,PLASTIC



15127-931

Select Brand Dist. Nighttime Cold and Flu Relief 16 BLISTER PACK in 1 CARTON (15127-139-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


15127-139

Select Brand Dist. Nighttime Cold and Flu 177 mL in 1 BOTTLE, PLASTIC (15127-987-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


15127-987

DOH 690-292 May 2016 297 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSelect Brand Dist. Nighttime Cold and Flu 296 mL in 1 BOTTLE, PLASTIC

(15127-987-10)500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


15127-987

Select Brand Dist. Cold and Flu 177 mL in 1 BOTTLE, PLASTIC (15127-346-06)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


15127-346

Select Brand Dist. Cold and Flu 296 mL in 1 BOTTLE, PLASTIC (15127-346-10)

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


15127-346

Select Brand Dist. Day Time Cold and Flu 177 mL in 1 BOTTLE, PLASTIC (15127-466-06)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


15127-466

Select Brand Dist. Day Time Cold and Flu 296 mL in 1 BOTTLE, PLASTIC (15127-466-10)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


15127-466

Select Brand Dist. Flu Relief Therapy Daytime 237 LIQUID in 1 BOTTLE, PLASTIC (15127-923-08)


15127-923

Select Brand Dist. Childrens Cold and Cough 1 BOTTLE, PLASTIC in 1 BOX (15127-953-04) > 118 mL in 1 BOTTLE,PLASTIC

2 mg/10mL, 10 mg/10mL, 5 mg/10mL


15127-953

Select Brand Dist. Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (15127-309-04) > 118 mL in 1 BOTTLE,PLASTIC


DOH 690-292 May 2016 298 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSelect Brand Dist. Night Time Cough 177 mL in 1 BOTTLE, PLASTIC

(15127-881-06)30 mg/30mL, 12.5 mg/30mL


15127-881

Select Brand Dist. Cough Control DM 1 BOTTLE, PLASTIC in 1 BOX (15127-806-04) > 118 mL in 1 BOTTLE,PLASTIC


15127-806

Select Brand Dist. Cough Control DM Max 1 BOTTLE, PLASTIC in 1 BOX (15127-864-04) > 118 mL in 1 BOTTLE,PLASTIC

10 mg/5mL, 200 mg/5mL dextromethorphan HBr, guaifenesin

15127-864

Select Brand Dist. Cough Control DM Max 1 BOTTLE, PLASTIC in 1 BOX (15127-864-08) > 236 mL in 1 BOTTLE,PLASTIC

10 mg/5mL, 200 mg/5mL dextromethorphan HBr, guaifenesin

15127-864

Select Brand Dist. Adult Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (15127-384-04) > 118 mL in 1 BOTTLE,PLASTIC


15127-384

Select Brand Dist. Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOTTLE (15127-085-04) > 118 mL in 1 BOTTLE, PLASTIC


15127-085

Select Brand Dist. Tussin Cough and Chest Congestion DM 1 BOTTLE, PLASTIC in 1 BOX (15127-085-08) > 237 mL in 1 BOTTLE,PLASTIC


15127-085

Select Brand Dist. Tussin Multi Symptom Cold CF 1 BOTTLE, PLASTIC in 1 BOX (15127-382-04) > 118 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


15127-382

Select Brand Dist. Tussin Multi Symptom Cold CF 1 BOTTLE, PLASTIC in 1 BOX (15127-382-08) > 237 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


15127-382

DOH 690-292 May 2016 299 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSelect Brand Dist. Tussin CF 1 BOTTLE, PLASTIC in 1 BOX (15127-


20 mg/10mL, 400 mg/10mL, 10 mg/10mL


15127-412

Select Brand Distributors Select Brand Tab Tussin 2 BLISTER PACK in 1 CARTON (15127-471-24) > 12 TABLET in 1 BLISTER PACK


15127-471

Select Brand Distributors Select Brand Mucus Relief 1 BOTTLE in 1 CARTON (15127-170-50) > 50 TABLET in 1 BOTTLE


15127-170

Select Corporation Cold Relief Severe Pain Cough 2 TABLET in 1 PACKET (52904-456-02)

325 mg/1, 5 mg/1, 200 mg/1, 15 mg/1

Acetaminophen,Guaifenesin, Phenylephrine HCl, Dextromethorphan Hydrobromide

52904-456

Selgel MÃ©xico, S.A. de C.V. Cough and Cold 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58596-001-12)

250 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


58596-001

Seyer Pharmatec, Inc. Panatuss 60 mL in 1 BOTTLE (11026-2662-2) .5 mg/mL, 5 mg/mL, 2.5 mg/mL


11026-2662

Seyer Pharmatec, Inc. Panatuss 118 mL in 1 BOTTLE (11026-2675-4) 2 mg/5mL, 20 mg/5mL, 10 mg/5mL


11026-2675

Seyer Pharmatec, Inc. Broncotron 118 mL in 1 BOTTLE (11026-2640-4) 10 mg/5mL, 100 mg/5mL Dextromethorphan, Guaifenesin

11026-2640

Seyer Pharmatec, Inc. Broncotron 1 BOTTLE in 1 CARTON (11026-2650-4) > 118 mL in 1 BOTTLE


11026-2650

DOH 690-292 May 2016 300 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSeyer Pharmatec, Inc. Broncotron PED 1 BOTTLE in 1 CARTON (11026-2780-



11026-2780

Seyer Pharmatec, Inc. Broncotron PED 1 BOTTLE, DROPPER in 1 CARTON (11026-2790-2) > 60 mL in 1 BOTTLE, DROPPER

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


11026-2790

SEYER PHARMATEC, INC. Broncotron 118 mL in 1 BOTTLE (11026-2681-4) 200 mg/5mL, 20 mg/5mL, 5 mg/5mL

Guaifenesin, Dextromethorphan, Phenyphrine Hydrchloride

11026-2681

Shopko Shopko Chest Congestion Relief DMTDM 1 TABLET in 1 CARTON (37012-078-01)


37012-078

Shopko Shopko Chest Congestion Relief DMTDM 50 TABLET in 1 BOTTLE, PLASTIC (37012-078-50)


37012-078

Shopko Stores Operating Co., LLC night time 12 BLISTER PACK in 1 CARTON (37012-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37012-056

Shopko Stores Operating Co., LLC Nighttime 354 mL in 1 BOTTLE (37012-335-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37012-335

Shopko Stores Operating Co., LLC cold and flu relief 354 mL in 1 BOTTLE (37012-459-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37012-459

Shopko Stores Operating Co., LLC Night Time 12 BLISTER PACK in 1 CARTON (37012-977-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37012-977

DOH 690-292 May 2016 301 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCShopko Stores Operating Co., LLC Nighttime 354 mL in 1 BOTTLE (37012-763-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


37012-763

Shopko Stores Operating Co., LLC Day Time 12 BLISTER PACK in 1 CARTON (37012-548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


37012-548

Shopko Stores Operating Co., LLC Daytime 354 mL in 1 BOTTLE (37012-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


37012-603

Shopko Stores Operating Co., LLC Daytime 354 mL in 1 BOTTLE (37012-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


37012-656

Shopko Stores Operating Co., LLC Day Time 12 BLISTER PACK in 1 CARTON (37012-994-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37012-994

Shopko Stores Operating Co., LLC Cough DM 1 BOTTLE in 1 CARTON (37012-384-21) > 89 mL in 1 BOTTLE


Shopko Stores Operating Co., LLC Nighttime Cough Relief 354 mL in 1 BOTTLE (37012-668-40) 30 mg/30mL, 12.5 mg/30mL


37012-668

Shopko Stores Operating Co., LLC Adults Tussin DM 1 BOTTLE in 1 CARTON (37012-359-34) > 237 mL in 1 BOTTLE


37012-359

Shopko Stores Operating Co., LLC Tussin CF Max 1 BOTTLE in 1 CARTON (37012-296-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


37012-296

Shopko Stores Operating Co., LLC Tussin CF 1 BOTTLE in 1 CARTON (37012-516-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


37012-516

DOH 690-292 May 2016 302 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCShopko Stores Operating Co., LLC. Night time cold/flu relief multi symptom 2 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


37012-480

Shopko Stores Operating Co., LLC. Night time cold/flu relief multi symptom 2 BLISTER PACK in 1 CARTON (37012-480-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37012-480

Shopko Stores Operating Co., LLC. Day Time Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (37012-470-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37012-470

Shopko Stores Operating Co., LLC. Day Time Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (37012-470-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37012-470

Silarx Pharmaceutical, Inc Brotapp PE-DM Cough and Cold Liquid 118 mL in 1 BOTTLE, PLASTIC (54838-147-40)


Brotapp PE-DM Cough and Cold Liquid

54838-147

Silarx Pharmaceutical, Inc Brotapp PE-DM Cough and Cold Liquid 237 mL in 1 BOTTLE, PLASTIC (54838-147-70)


Brotapp PE-DM Cough and Cold Liquid

54838-147

Silarx Pharmaceuticals, Inc Brotapp DM Cold and Cough 118 mL in 1 BOTTLE, PLASTIC (54838-136-40)



54838-136

DOH 690-292 May 2016 303 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSilarx Pharmaceuticals, Inc Brotapp DM Cold and Cough 237 mL in 1 BOTTLE, PLASTIC

(54838-136-70)1 mg/5mL, 15 mg/5mL, 5 mg/5mL


54838-136

Silarx Pharmaceuticals, Inc Pediatric Cough and Cold Medicine 120 mL in 1 BOTTLE, PLASTIC (54838-115-40)



54838-115

Silarx Pharmaceuticals, Inc Silphen DM Cough 118 mL in 1 BOTTLE, PLASTIC (54838-105-40)


54838-105

Silarx Pharmaceuticals, Inc Siltussin DM DAS Cough Formula 118 mL in 1 BOTTLE, PLASTIC (54838-133-40)


54838-133

Silarx Pharmaceuticals, Inc Diabetic Siltussin DM DAS-Na 118 mL in 1 BOTTLE, PLASTIC (54838-139-40)


54838-139

Silarx Pharmaceuticals, Inc Diabetic Maximum Strength Siltussin DM DAS-Na 118 mL in 1 BOTTLE, PLASTIC (54838-140-40)


54838-140

Silarx Pharmaceuticals,Inc Siltussin DM 118 mL in 1 BOTTLE, PLASTIC (54838-209-40)


54838-209

Silarx Pharmaceuticals,Inc Siltussin DM 237 mL in 1 BOTTLE, PLASTIC (54838-209-70)


54838-209

DOH 690-292 May 2016 304 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSilarx Pharmaceuticals,Inc Siltussin DM 473 mL in 1 BOTTLE, PLASTIC

(54838-209-80)100 mg/5mL, 10 mg/5mL Guaifenesin and


54838-209

SMART SENSE (Kmart) Nighttime 2 BLISTER PACK in 1 CARTON (49738-480-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49738-480

SMART SENSE (Kmart) DayTime Cold Flu Non-Drowsy 1 BLISTER PACK in 1 BOX (49738-470-24) > 24 CAPSULE, LIQUIDFILLED in 1 BLISTER PACK


49738-470

SMART SENSE (Kmart) Mucus DM 1 BOTTLE, PLASTIC in 1 BOX (49738-109-30) > 30 TABLET in 1 BOTTLE,PLASTIC


49738-109

SOHM Inc. SohMed Cold Relief 1 BOTTLE, PLASTIC in 1 CARTON (50405-006-24) > 24 TABLET in 1 BOTTLE, PLASTIC

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


50405-006

SPIRIT PHARMACEUTICALS LLC MULTI-SYMPTOM NITETIME 1 BLISTER PACK in 1 CARTON (68210-0105-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


68210-0105

SPIRIT PHARMACEUTICALS LLC MULTI-SYMPTOM DAYTIME 1 BLISTER PACK in 1 CARTON (68210-0104-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


68210-0104

DOH 690-292 May 2016 305 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSpirit Pharmaceuticals LLC DEXTROMETHORPHAN Hydrobromide 1 BOTTLE in 1 CARTON (68210-0005-

0) > 15 CAPSULE, LIQUID FILLED in 1BOTTLE


68210-0005

SPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE

4 CAPSULE, LIQUID FILLED in 1 BOX (68210-0102-1)

325 mg/1, 15 mg/1, 6.25 mg/1


68210-0102



325 mg/1, 15 mg/1, 6.25 mg/1


68210-0102



325 mg/1, 15 mg/1, 6.25 mg/1


68210-0102



325 mg/1, 15 mg/1, 6.25 mg/1


68210-0102



325 mg/1, 15 mg/1, 6.25 mg/1


68210-0102



325 mg/1, 15 mg/1, 6.25 mg/1


68210-0102

DOH 690-292 May 2016 306 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN, DEXTROMETHORPHAN

HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE



68210-0101

SPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE



68210-0101




68210-0101




68210-0101




68210-0101

DOH 690-292 May 2016 307 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN, DEXTROMETHORPHAN

HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE



68210-0101

SPIRIT PHARMACEUTICALS,LLC N - TIME 1 BAG in 1 DRUM (68210-1500-4) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

325 mg/1, 6.25 mg/1, 15 mg/1

ACETAMINOPHEN, DOXYLAMINE SUCCINATE, and DEXTROMETHORPHAN HYDROBROMIDE

68210-1500


325 mg/1, 6.25 mg/1, 15 mg/1


68210-1500


325 mg/1, 6.25 mg/1, 15 mg/1


68210-1500


325 mg/1, 6.25 mg/1, 15 mg/1


68210-1500

SPIRIT PHARMACEUTICALS,LLC D - TIME 1 BAG in 1 DRUM (68210-1490-4) > 4000 CAPSULE, LIQUID FILLED in 1 BAG


68210-1490

DOH 690-292 May 2016 308 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSPIRIT PHARMACEUTICALS,LLC D - TIME 1 BAG in 1 DRUM (68210-1490-5) >



68210-1490



68210-1490



68210-1490

SPIRIT PHARMACEUTICALS,LLC DEXTROMETHORPHAN HYDROBROMIDE 1 BAG in 1 DRUM (68210-1530-1) > 10000 CAPSULE, LIQUID FILLED in 1 BAG


68210-1530



68210-1530



68210-1530



68210-1530

DOH 690-292 May 2016 309 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSummit Industries, Inc. Creomulsion 1 BOTTLE in 1 CARTON (12090-0015-

0) > 118 mL in 1 BOTTLE (12090-0015-1)


12090-0015

Summit Industries, Inc. Creomulsion 1 BOTTLE in 1 CARTON (12090-0024-0) > 118 mL in 1 BOTTLE (12090-0024-1)


12090-0024

Supervalu Day Time with PE 177 mL in 1 BOTTLE, PLASTIC (41163-201-16)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL

Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride

41163-201

Supervalu Inc Equaline nighttime cold 1 BLISTER PACK in 1 CARTON (41163-014-53) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


41163-014

Supervalu Inc Equaline nighttime cold 2 BLISTER PACK in 1 CARTON (41163-014-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


41163-014

Supervalu Inc equaline childrens cold 1 BOTTLE in 1 CARTON (41163-903-26) > 118 mL in 1 BOTTLE



41163-903

Supervalu Inc Equaline Nighttime Cold and Flu Relief 12 BLISTER PACK in 1 CARTON (41163-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41163-056

DOH 690-292 May 2016 310 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSupervalu Inc equaline nighttime cold and flu relief 237 mL in 1 BOTTLE (41163-335-34) 650 mg/30mL, 30


41163-335

Supervalu Inc equaline nighttime cold and flu relief 296 mL in 1 BOTTLE (41163-335-38) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


41163-335



41163-335

Supervalu Inc Equaline nighttime 355 mL in 1 BOTTLE (41163-872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


41163-872

Supervalu Inc equaline nighttime cold and flu relief 2 BLISTER PACK in 1 CARTON (41163-977-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41163-977

Supervalu Inc equaline nighttime 296 mL in 1 BOTTLE (41163-990-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


41163-990



41163-459



41163-459



41163-459

DOH 690-292 May 2016 311 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSupervalu Inc equaline nighttime cold and flu relief 2 BOTTLE in 1 CARTON (41163-459-



41163-459

Supervalu Inc equaline nighttime severe cold and flu 355 mL in 1 BOTTLE (41163-763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


41163-763

Supervalu Inc equaline daytime severe cold and flu relief 1 BOTTLE in 1 CARTON (41163-603-40) > 355 mL in 1 BOTTLE



41163-603

Supervalu Inc Equaline Mucus Relief 10 BLISTER PACK in 1 CARTON (41163-381-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41163-381

Supervalu Inc Equaline Mucus Relief 10 BLISTER PACK in 1 CARTON (41163-922-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41163-922

Supervalu Inc equaline daytime cold and flu relief 2 BLISTER PACK in 1 CARTON (41163-994-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41163-994

Supervalu Inc equaline daytime cold 1 BLISTER PACK in 1 CARTON (41163-371-53) > 12 TABLET, FILM COATED in 1 BLISTER PACK


41163-371

Supervalu Inc equaline daytime cold and flu relief 237 mL in 1 BOTTLE (41163-656-34) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41163-656

DOH 690-292 May 2016 312 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSupervalu Inc equaline daytime cold and flu relief 296 mL in 1 BOTTLE (41163-656-38) 325 mg/15mL, 10


41163-656

Supervalu Inc equaline daytime cold and flu relief 355 mL in 1 BOTTLE (41163-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41163-656

Supervalu Inc daytime cold and flu relief 2 BLISTER PACK in 1 CARTON (41163-215-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41163-215

Supervalu Inc equaline childrens cold and cough 1 BOTTLE in 1 CARTON (41163-987-26) > 118 mL in 1 BOTTLE



41163-987

Supervalu Inc equaline cough dm 1 BOTTLE in 1 CARTON (41163-384-21) > 89 mL in 1 BOTTLE


Supervalu Inc Equaline Cough DM 1 BOTTLE in 1 CARTON (41163-958-21) > 89 mL in 1 BOTTLE


Supervalu Inc Equaline tussin cough 1 BOTTLE in 1 CARTON (41163-300-26) > 118 mL in 1 BOTTLE


41163-300

Supervalu Inc equaline nighttime cough relief 355 mL in 1 BOTTLE (41163-551-40) 30 mg/30mL, 12.5 mg/30mL


41163-551

Supervalu Inc Equaline night time 177 mL in 1 BOTTLE (41163-668-30) 30 mg/30mL, 12.5 mg/30mL


41163-668



41163-668



41163-668

DOH 690-292 May 2016 313 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSupervalu Inc Equaline tussin 1 BOTTLE in 1 CARTON (41163-359-



Supervalu Inc Equaline tussin 1 BOTTLE in 1 CARTON (41163-359-34) > 237 mL in 1 BOTTLE


41163-359

Supervalu Inc Equaline tussin cough and chest congestion 1 BOTTLE in 1 CARTON (41163-799-26) > 118 mL in 1 BOTTLE


41163-799

Supervalu Inc Equaline tussin cough and chest congestion 1 BOTTLE in 1 CARTON (41163-799-34) > 237 mL in 1 BOTTLE


41163-799

Supervalu Inc Equaline adult tussin 1 BOTTLE in 1 CARTON (41163-578-26) > 118 mL in 1 BOTTLE


41163-578

Supervalu Inc equaline childrens mucus relief 1 BOTTLE in 1 CARTON (41163-839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


41163-839

Supervalu Inc equaline tussin 1 BOTTLE in 1 CARTON (41163-388-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


41163-388

Supervalu Inc equaline tussin 1 BOTTLE in 1 CARTON (41163-388-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


41163-388

Supervalu Inc equaline tussin cough and cold 1 BOTTLE in 1 CARTON (41163-516-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


41163-516

Supervalu Inc equaline tussin cough and cold 1 BOTTLE in 1 CARTON (41163-516-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


41163-516

SUPERVALU INC. Non Drowsy Cold and Cough PE 1 BLISTER PACK in 1 CARTON (41163-010-09) > 20 CAPSULE, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


41163-010

DOH 690-292 May 2016 314 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCSUPERVALU INC. daytime severe cold 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan HBr, Guiafenesin, Phenylephrine HCl

41163-503

Supervalu Inc. Daytime Severe Cold and Flu Relief 1 BLISTER PACK in 1 CARTON (41163-510-02) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41163-510

Supervalu Inc. Pressure and Pain PE Plus Cold 2 BLISTER PACK in 1 CARTON (41163-513-02) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


41163-513

SUPERVALU INC. Day Time Cold Head Congestion Severe 1 BLISTER PACK in 1 CARTON (41163-902-08) > 24 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41163-902

SUPERVALU INC. Cold Multi-Symptom Daytime Rapid Release 2 BLISTER PACK in 1 CARTON (41163-560-08) > 12 TABLET in 1 BLISTER PACK


41163-560

SUPERVALU INC. Cough and Cold Relief HBP 2 BLISTER PACK in 1 CARTON (41163-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK


41163-411

DOH 690-292 May 2016 315 of 379


Target Corporation up and up childrens multi symptom cold 1 BOTTLE in 1 CARTON (11673-903-26) > 118 mL in 1 BOTTLE



11673-903

Target Corporation Up and Up Cold Flu Relief 295 mL in 1 BOTTLE (11673-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11673-908

Target Corporation up and up cold and flu relief 10 BLISTER PACK in 1 CARTON (11673-977-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11673-977

Target Corporation up and up cold and flu relief 12 BLISTER PACK in 1 CARTON (11673-977-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11673-977

Target Corporation up and up nighttime cold and flu 12 BLISTER PACK in 1 CARTON (11673-626-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11673-626

Target Corporation up and up nighttime cold and flu 24 BLISTER PACK in 1 CARTON (11673-626-67) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11673-626

Target Corporation up and up nighttime cold and flu 12 BLISTER PACK in 1 CARTON (11673-574-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11673-574

T

DOH 690-292 May 2016 316 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTarget Corporation up and up nighttime cold and flu 355 mL in 1 BOTTLE (11673-019-40) 650 mg/30mL, 30


11673-019

Target Corporation Target Cold/Flu Relief 296 mL in 1 BOTTLE (11673-041-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


11673-041

Target Corporation up and up cold flu relief 12 BLISTER PACK in 1 CARTON (11673-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


11673-056

Target Corporation up and up cold and flu relief 295 mL in 1 BOTTLE (11673-335-38) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


11673-335



11673-335



11673-459



11673-459

Target Corporation up and up nighttime cold and flu 355 mL in 1 BOTTLE (11673-500-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


11673-500

DOH 690-292 May 2016 317 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTarget Corporation up and up severe cold and flu 355 mL in 1 BOTTLE (11673-012-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


11673-012

Target Corporation Severe Cold and Flu 2 BLISTER PACK in 1 CARTON (11673-677-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


11673-677

Target Corporation Up and Up sever cold and flu 355 mL in 1 BOTTLE (11673-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


11673-603

Target Corporation severe cold and flu 2 BLISTER PACK in 1 CARTON (11673-640-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11673-640

Target Corporation PE multi-stymptom cold and cough relief 2 BLISTER PACK in 1 CARTON (11673-645-09) > 10 CAPSULE, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


11673-645

Target Corporation Up and Up Mucus Relief 10 BLISTER PACK in 1 CARTON (11673-803-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11673-803


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11673-922

DOH 690-292 May 2016 318 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTarget Corporation Severe Cold Relief 1 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11673-503


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11673-381


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11673-381

Target Corporation up and up fast mucus relief severe cold 10 BLISTER PACK in 1 CARTON (11673-006-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


11673-006

Target Corporation Up and Up Cold Flu Relief 12 BLISTER PACK in 1 CARTON (11673-215-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11673-215

Target Corporation Up and Up Daytime Cold and Flu 355 mL in 1 BOTTLE (11673-301-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11673-301

Target Corporation Multi-Symptom Daytime Cold 1 BLISTER PACK in 1 CARTON (11673-560-08) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11673-560

Target Corporation Daytime Multi-Symptom Cold Relief 1 BLISTER PACK in 1 BOX (11673-470-08) > 24 TABLET in 1 BLISTERPACK


11673-470

DOH 690-292 May 2016 319 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTarget Corporation Up and Up Cold and Head Congestion 2 BLISTER PACK in 1 CARTON



11673-402

Target Corporation up and up flu and severe cold and cough relief 6 POWDER, FOR SOLUTION in 1 CARTON (11673-096-91)

650 mg/1, 20 mg/1, 10 mg/1


11673-096

Target Corporation Up and Up Cold Flu Relief 295 mL in 1 BOTTLE (11673-656-38) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11673-656

Target Corporation Up and Up Cold Flu Relief 355 mL in 1 BOTTLE (11673-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


11673-656

Target Corporation Up and Up Daytime Cold and Flu 12 BLISTER PACK in 1 CARTON (11673-710-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11673-710

Target Corporation Up and Up Daytime Cold and Flu 24 BLISTER PACK in 1 CARTON (11673-710-67) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11673-710

Target Corporation up and up cold flu relief 10 BLISTER PACK in 1 CARTON (11673-994-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11673-994

Target Corporation up and up cold flu relief 12 BLISTER PACK in 1 CARTON (11673-994-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


11673-994

DOH 690-292 May 2016 320 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTarget Corporation up and up childrens cold and cough 1 BOTTLE in 1 CARTON (11673-987-



11673-987

Target Corporation up and up childrens cold and cough 1 BOTTLE in 1 CARTON (11673-987-34) > 237 mL in 1 BOTTLE



11673-987

Target Corporation up and up 12 hour cough relief 1 BOTTLE in 1 CARTON (11673-114-21) > 89 mL in 1 BOTTLE


Target Corporation up and up 12 hour cough relief 1 BOTTLE in 1 CARTON (11673-114-28) > 148 mL in 1 BOTTLE


Target Corporation up and up cough suppressant dm 1 BOTTLE in 1 CARTON (11673-384-21) > 89 mL in 1 BOTTLE


Target Corporation up and up cough suppressant dm 1 BOTTLE in 1 CARTON (11673-384-28) > 148 mL in 1 BOTTLE


Target Corporation Up and Up Cough Suppressant DM 1 BOTTLE in 1 CARTON (11673-958-21) > 89 mL in 1 BOTTLE


Target Corporation Up and Up Cough Suppressant DM 1 BOTTLE in 1 CARTON (11673-958-28) > 148 mL in 1 BOTTLE


TARGET Corporation Fast Mucus Relief Cold Flu and Sore Throat 177 mL in 1 BOTTLE, PLASTIC (11673-336-06)



11673-336

Target Corporation up and up adult cough formula dm max 1 BOTTLE in 1 CARTON (11673-799-26) > 118 mL in 1 BOTTLE


11673-799

Target Corporation up and up adult cough formula dm max 1 BOTTLE in 1 CARTON (11673-799-34) > 236 mL in 1 BOTTLE


11673-799

Target Corporation Up and Up adult cough formula DM 1 BOTTLE in 1 CARTON (11673-359-26) > 118 mL in 1 BOTTLE


11673-359

DOH 690-292 May 2016 321 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTarget Corporation Up and Up adult cough formula DM 1 BOTTLE in 1 CARTON (11673-359-



Target Corporation Up and Up Childrens Mucus Relief and Cough 1 BOTTLE in 1 CARTON (11673-419-26) > 118 mL in 1 BOTTLE


11673-419

Target Corporation up and up dm max 1 BOTTLE in 1 CARTON (11673-014-34) > 236 mL in 1 BOTTLE


11673-014

TARGET Corporation Mucus and Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (11673-109-30) > 30 TABLET in 1 BOTTLE,PLASTIC


11673-109

Target Corporation up and up adult cough and cold 1 BOTTLE in 1 CARTON (11673-516-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


11673-516

Target Corporation up and up adult cough and cold 1 BOTTLE in 1 CARTON (11673-516-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 100 mg/5mL, 5 mg/5mL


11673-516

Target Corporation up and up tussin multi symptom cold 1 BOTTLE in 1 CARTON (11673-296-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


11673-296

Target Corporation up and up tussin multi symptom cold 1 BOTTLE in 1 CARTON (11673-296-34) > 237 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


11673-296

Target Corporation Up and Up maximum Strength fast mucus relief 177 mL in 1 BOTTLE (11673-738-06) 20 mg/20mL, 400 mg/20mL, 10 mg/20mL


11673-738

Taro Pharmaceuticals U.S.A., Inc. Daytime 6 POWDER, FOR SOLUTION in 1 CARTON (51672-2112-7)

650 mg/1, 20 mg/1, 10 mg/1


51672-2112

Teral Inc. Sorbutuss 474 mL in 1 BOTTLE, PLASTIC (68436-120-16)

100 mg/5mL, 10 mg/5mL Sorbutuss 68436-120

DOH 690-292 May 2016 322 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTeresa Cecena DBA Genesis XL3 XTRA 20 mg in 1 BLISTER PACK (69772-

440-01)10 mg/mg, 5 mg/mg, 250 mg/mg, 2 mg/mg

acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled

69772-440

Teresa Cecena DBA Genesis XL3 XTRA 12 mg in 1 BLISTER PACK (69772-440-02)

10 mg/mg, 5 mg/mg, 250 mg/mg, 2 mg/mg

acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled

69772-440

The Kroger Co. Mucus Relief DM 1 BOTTLE in 1 BOX (30142-109-30) > 30 TABLET, COATED in 1 BOTTLE


30142-109

The Procter & Gamble Manufacturin Vicks NyQuil 236 mL in 1 BOTTLE, PLASTIC (37000-807-08)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37000-807


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


37000-807

The Procter & Gamble Manufacturin Vicks NyQuil 2 CAPSULE, LIQUID FILLED in 1 POUCH (37000-557-02)

325 mg/1, 15 mg/1, 6.25 mg/1


37000-557

The Procter & Gamble Manufacturin Vicks NyQuil 4 BLISTER PACK in 1 CARTON (37000-557-08) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


37000-557

DOH 690-292 May 2016 323 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCThe Procter & Gamble Manufacturin Vicks NyQuil 8 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


37000-557


325 mg/1, 15 mg/1, 6.25 mg/1


37000-557


325 mg/1, 15 mg/1, 6.25 mg/1


37000-557


325 mg/1, 15 mg/1, 6.25 mg/1


37000-557

The Procter & Gamble Manufacturin Vicks NyQuil D 195 mL in 1 BOTTLE, PLASTIC (37000-654-10)


Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate, and Pseudoephedrine Hydrochloride

37000-654

The Procter & Gamble Manufacturin Vicks DayQuil 2 CAPSULE, LIQUID FILLED in 1 POUCH (37000-558-02)


37000-558

DOH 690-292 May 2016 324 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCThe Procter & Gamble Manufacturin Vicks DayQuil 4 BLISTER PACK in 1 CARTON



37000-558

The Procter & Gamble Manufacturin Vicks DayQuil 8 BLISTER PACK in 1 CARTON (37000-558-16) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


37000-558



37000-558



37000-558



37000-558

The Procter & Gamble Manufacturin Vicks DayQuil 236 mL in 1 BOTTLE, PLASTIC (37000-555-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


37000-555


325 mg/15mL, 10 mg/15mL, 5 mg/15mL


37000-555

DOH 690-292 May 2016 325 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCThe Procter & Gamble Manufacturin Vicks DayQuil 2 BOTTLE, PLASTIC in 1 PACKAGE,

COMBINATION (37000-555-24) > 236 mL in 1 BOTTLE, PLASTIC

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


37000-555

The Procter & Gamble Manufacturin Vicks Childrens NyQuil 236 mL in 1 BOTTLE, PLASTIC (37000-556-08)

2 mg/15mL, 15 mg/15mL Chlorpheniramine maleate and Dextromethorphan Hydrobromide

37000-556



37000-565



37000-565


30 mg/30mL, 12.5 mg/30mL

Dextromethorphan Hydrobromide and Doxylamine succinate

37000-550


30 mg/30mL, 12.5 mg/30mL

Dextromethorphan Hydrobromide and Doxylamine succinate

37000-550

The Procter & Gamble Manufacturin Vicks NyQuil Severe 2 TABLET, COATED in 1 POUCH (37000-813-02)

325 mg/1, 5 mg/1, 6.25 mg/1, 10 mg/1

Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide

37000-813

The Procter & Gamble Manufacturin Vicks NyQuil Severe 6 BLISTER PACK in 1 CARTON (37000-813-12) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 5 mg/1, 6.25 mg/1, 10 mg/1


37000-813

DOH 690-292 May 2016 326 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCThe Procter & Gamble Manufacturin Vicks NyQuil Severe 12 BLISTER PACK in 1 CARTON


325 mg/1, 5 mg/1, 6.25 mg/1, 10 mg/1


37000-813

The Procter & Gamble Manufacturin Vicks NyQuil Severe 36 BLISTER PACK in 1 CARTON (37000-813-72) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 5 mg/1, 6.25 mg/1, 10 mg/1


37000-813

The Procter & Gamble Manufacturin Vicks NyQuil Severe 236 mL in 1 BOTTLE, PLASTIC (37000-815-08)

650 mg/mL, 10 mg/mL, 12.5 mg/mL, 20 mg/mL


37000-815

The Procter & Gamble Manufacturin Vicks NyQuil Severe 354 mL in 1 BOTTLE, PLASTIC (37000-815-12)



37000-815

The Procter & Gamble Manufacturin Vicks NyQuil Severe 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (37000-815-24) > 354 mL in 1 BOTTLE, PLASTIC (37000-815-12)



37000-815

DOH 690-292 May 2016 327 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCThe Procter & Gamble Manufacturin Vicks NyQuil Severe 3 BOTTLE, PLASTIC in 1 PACKAGE,

COMBINATION (37000-815-36) > 354 mL in 1 BOTTLE, PLASTIC (37000-815-12)



37000-815

TIME CAP LABORATORIES, INC. MUCOSA DM 100000 TABLET in 1 CARTON (49483-280-00)


49483-280

TIME CAP LABORATORIES, INC. MUCOSA DM 60 TABLET in 1 BOTTLE, PLASTIC (49483-280-06)


49483-280

TOP CARE (Topco Associates LLC) Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (36800-297-04) > 118 mL in 1 BOTTLE,PLASTIC



36800-297

TOP CARE (Topco Associates LLC) Flu Relief 1 BOTTLE, PLASTIC in 1 BOX (36800-000-04) > 118 mL in 1 BOTTLE,PLASTIC



36800-000

TOP CARE (Topco Associates LLC) Severe Cold and Cough 245 mL in 1 BOTTLE, PLASTIC (36800-316-08)

650 mg/30mL, 20 mg/30mL, 10 mg/30mL


36800-316

TOP CARE (Topco Associates LLC) Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (36800-509-04) > 118 mL in 1 BOTTLE,PLASTIC


TOP CARE (Topco Associates LLC) Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (36800-454-04) > 118 mL in 1 BOTTLE,PLASTIC


DOH 690-292 May 2016 328 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTOP CARE (Topco Associates LLC) Mucus Relief 177 mL in 1 BOTTLE, PLASTIC



36800-036

TOP CARE (Topco Associates LLC) Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (36800-037-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


36800-037

TopCare Cold and Flu Severe 2 BLISTER PACK in 1 CARTON (36800-502-05) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-502

TOPCARE (Topco Associates LLC) TopCare Daytime Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (36800-540-06)

650 mg/1, 20 mg/1, 10 mg/1


36800-540

Topco mixed berry throat lozenge 18 LOZENGE in 1 CARTON (36800-999-18)

7.5 mg/1, 5 mg/1 benzocaine, dextromethorhan hydrobromide

36800-999

Topco Associates LLC Topcare Cold 1 BOTTLE in 1 CARTON (36800-903-26) > 118 mL in 1 BOTTLE



36800-903

Topco Associates LLC Topcare Cold Head Congestion 2 BLISTER PACK in 1 CARTON (36800-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


36800-393

DOH 690-292 May 2016 329 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC TopCare Cold 2 BLISTER PACK in 1 CARTON


325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


36800-014

Topco Associates LLC Topcare Cough and Sore Throat 237 mL in 1 BOTTLE (36800-698-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

36800-698

Topco Associates LLC Topcare Cold and Cough 237 mL in 1 BOTTLE (36800-901-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

36800-901

Topco Associates LLC TopCare Nite Time 1 BLISTER PACK in 1 CARTON (36800-977-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


36800-977

Topco Associates LLC TopCare Nite Time 2 BLISTER PACK in 1 CARTON (36800-977-60) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


36800-977

Topco Associates LLC Topcare Nite Time 296 mL in 1 BOTTLE (36800-990-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


36800-990

Topco Associates LLC topcare nite time cold and flu relief 12 BLISTER PACK in 1 CARTON (36800-998-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


36800-998

Topco Associates LLC topcare nite time cold and flu relief 8 BLISTER PACK in 1 CARTON (36800-998-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


36800-998

DOH 690-292 May 2016 330 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC Topcare Nite Time 355 mL in 1 BOTTLE (36800-872-40) 650 mg/30mL, 30


36800-872

Topco Associates LLC TopCare Nite Time 177 mL in 1 BOTTLE (36800-908-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


36800-908

Topco Associates LLC TopCare Nite Time 296 mL in 1 BOTTLE (36800-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


36800-908

Topco Associates LLC Topcare Cough and Sore Throat 237 mL in 1 BOTTLE (36800-666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


36800-666

Topco Associates LLC Topcare Cold and Cough 237 mL in 1 BOTTLE (36800-703-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


36800-703



36800-041



36800-041

Topco Associates LLC topcare nite time cold and flu relief 177 mL in 1 BOTTLE (36800-335-30) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


36800-335



36800-335

DOH 690-292 May 2016 331 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC topcare nite time cold and flu relief 296 mL in 1 BOTTLE (36800-335-38) 650 mg/30mL, 30


36800-335



36800-335

Topco Associates LLC topcare nite time cold and flu 12 BLISTER PACK in 1 CARTON (36800-143-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


36800-143

Topco Associates LLC topcare nite time cold and flu 8 BLISTER PACK in 1 CARTON (36800-143-73) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


36800-143



36800-459



36800-459



36800-459



36800-459

DOH 690-292 May 2016 332 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC topcare nite time cold and flu 12 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


36800-560

Topco Associates LLC topcare nite time cold and flu 355 mL in 1 BOTTLE (36800-291-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


36800-291

Topco Associates LLC topcare severe sinus congestion 10 BLISTER PACK in 1 CARTON (36800-345-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


36800-345

Topco Associates LLC Topcare Nite Time Cold and Flu 237 mL in 1 BOTTLE (36800-763-34) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


36800-763

Topco Associates LLC Topcare Nite Time Cold and Flu 355 mL in 1 BOTTLE (36800-763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


36800-763

Topco Associates LLC TopCare Pain Relief Cold Nightttime 237 mL in 1 BOTTLE (36800-920-34) 325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL, 5 mg/15mL


36800-920

Topco Associates LLC TopCare Cold Max 240 mL in 1 BOTTLE (36800-701-34) 325 mg/15mL, 10 mg/15mL, 6.25 mg/15mL, 5 mg/15mL


36800-701

DOH 690-292 May 2016 333 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC Topcare Nite Time D 296 mL in 1 BOTTLE (36800-609-38) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mL, 30 mg/15mL


36800-609

Topco Associates LLC Topcare Cold Multi Symptom Severe 2 BLISTER PACK in 1 CARTON (36800-308-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-308

Topco Associates LLC Topcare Cold Head Congestion Severe 2 BLISTER PACK in 1 CARTON (36800-234-62) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-234

Topco Associates LLC Topcare Mucus Relief 10 BLISTER PACK in 1 CARTON (36800-265-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-265


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-265

Topco Associates LLC Topcare Day Time Cold and Flu 237 mL in 1 BOTTLE (36800-603-34) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


36800-603

Topco Associates LLC Topcare Day Time Cold and Flu 355 mL in 1 BOTTLE (36800-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


36800-603

DOH 690-292 May 2016 334 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC topcare day time cold and flu severe 6 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-548

Topco Associates LLC topcare day time cold and flu severe 12 BLISTER PACK in 1 CARTON (36800-548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-548

Topco Associates LLC Topcare Cold and Flu 12 BLISTER PACK in 1 CARTON (36800-453-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-453


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-922


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


36800-922

Topco Associates LLC topcare day time 6 BLISTER PACK in 1 CARTON (36800-700-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


36800-700



36800-700



36800-700

DOH 690-292 May 2016 335 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC topcare day time 8 BLISTER PACK in 1 CARTON



36800-700

Topco Associates LLC Top Care Day Time 177 mL in 1 BOTTLE (36800-656-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


36800-656

Topco Associates LLC Top Care Day Time 296 mL in 1 BOTTLE (36800-656-38) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


36800-656

Topco Associates LLC Topcare Day time cold and flu relief 1 BLISTER PACK in 1 CARTON (36800-503-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


36800-503



36800-503



36800-503



36800-503

Topco Associates LLC topcare day time cold and flu relief 237 mL in 1 BOTTLE (36800-522-34) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


36800-522

Topco Associates LLC topcare day time cold and flu relief 296 mL in 1 BOTTLE (36800-522-38) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


36800-522

DOH 690-292 May 2016 336 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC topcare day time cold and flu relief 355 mL in 1 BOTTLE (36800-522-40) 325 mg/15mL, 10


36800-522

Topco Associates LLC Topcare Cold Multi Symptom 2 BLISTER PACK in 1 CARTON (36800-371-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


36800-371

Topco Associates LLC Topcare DayTime 1 BLISTER PACK in 1 CARTON (36800-215-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


36800-215

Topco Associates LLC Topcare DayTime 2 BLISTER PACK in 1 CARTON (36800-215-60) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


36800-215

Topco Associates LLC Topcare Cold Head Congestion 2 BLISTER PACK in 1 CARTON (36800-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


36800-402

Topco Associates LLC topcare flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (36800-096-91)

650 mg/1, 20 mg/1, 10 mg/1


36800-096

Topco Associates LLC Topcare childrens cold and cough elixir 1 BOTTLE in 1 CARTON (36800-987-26) > 118 mL in 1 BOTTLE



36800-987

Topco Associates LLC TopCare Cough DM 1 BOTTLE in 1 CARTON (36800-899-21) > 89 mL in 1 BOTTLE


DOH 690-292 May 2016 337 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC TopCare Cough DM 1 BOTTLE in 1 CARTON (36800-958-




Topco Associates LLC Topcare Tussin 1 BOTTLE in 1 CARTON (36800-300-26) > 118 mL in 1 BOTTLE


36800-300

Topco Associates LLC Topcare Cough DM 1 BOTTLE in 1 CARTON (36800-552-21) > 89 mL in 1 BOTTLE


Topco Associates LLC Topcare Cough DM 1 BOTTLE in 1 CARTON (36800-552-28) > 148 mL in 1 BOTTLE


Topco Associates LLC TopCare Day Time Cough 296 mL in 1 BOTTLE (36800-473-38) 15 mg/15mL Dextromethorphan HBr 36800-473

Topco Associates LLC TopCare Day Time Cough 355 mL in 1 BOTTLE (36800-473-40) 15 mg/15mL Dextromethorphan HBr 36800-473



Topco Associates LLC topcare nite time 296 mL in 1 BOTTLE (36800-668-38) 30 mg/30mL, 12.5 mg/30mL


36800-668

Topco Associates LLC topcare nite time 355 mL in 1 BOTTLE (36800-668-40) 30 mg/30mL, 12.5 mg/30mL


36800-668

Topco Associates LLC Topcare Tussin DM Max 1 BOTTLE in 1 CARTON (36800-799-26) > 118 mL in 1 BOTTLE


36800-799

Topco Associates LLC Topcare Tussin DM Max 1 BOTTLE in 1 CARTON (36800-799-34) > 237 mL in 1 BOTTLE


36800-799

Topco Associates LLC Topcare tussin dm 1 BOTTLE in 1 CARTON (36800-578-26) > 118 mL in 1 BOTTLE


36800-578

DOH 690-292 May 2016 338 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCTopco Associates LLC Topcare Mucus Relief 1 BOTTLE in 1 CARTON (36800-419-



Topco Associates LLC Topcare Tussin DM 1 BOTTLE in 1 CARTON (36800-359-26) > 118 mL in 1 BOTTLE


36800-359



36800-359



36800-359

Topco Associates LLC topcare tussin cf max 1 BOTTLE in 1 CARTON (36800-296-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


36800-296

Topco Associates LLC topcare tussin cf max 1 BOTTLE in 1 CARTON (36800-296-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 400 mg/10mL, 10 mg/10mL


36800-296

Topco Associates LLC topcare tussin CF 1 BOTTLE in 1 CARTON (36800-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


36800-516

Topco Associates LLC topcare tussin CF 1 BOTTLE in 1 CARTON (36800-516-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


36800-516

Topco Associates LLC topcare childrens mucus relief multi symptom cold 1 BOTTLE in 1 CARTON (36800-839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


36800-839

Topco Associates LLC Topcare Cold and Cough 1 BOTTLE in 1 CARTON (36800-444-26) > 118 mL in 1 BOTTLE


36800-444

Tris Pharma Inc Dextromethorphan Polistirex 1 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE (27808-071-01) > 89 mL in 1 BOTTLE, UNIT-DOSE

30 mg/5mL Dextromethorphan Polistirex 27808-071

TYA Pharmaceuticals Siltussin DM 8 mL in 1 BOTTLE (64725-0209-1) 100 mg/5mL, 10 mg/5mL Guaifenesin and Dextromethorphan Hydrobromide

64725-0209

DOH 690-292 May 2016 339 of 379


Ultra Seal Corporation Ultra Tuss DM 474 mL in 1 BOTTLE (42213-161-93) 100 mg/5mL, 10 mg/5mL guaifenesin dextromethorphan HBr

42213-161

Ultra Seal Corporation Ultra Tuss Safe 1 BOTTLE in 1 CARTON (42213-162-83) > 119 mL in 1 BOTTLE (42213-162-86)

100 mg/5mL, 10 mg/5mL guaifenesin dextromethorphan HBr

42213-162

Unifirst First Aid Corporation Green Guard Cough and Cold Relief 50 PACKET in 1 BOX, UNIT-DOSE (47682-006-33) > 2 TABLET, FILM COATED in 1 PACKET (47682-006-99)

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-006

Unifirst First Aid Corporation Green Guard Cough and Cold Relief 125 PACKET in 1 BOX, UNIT-DOSE (47682-006-48) > 2 TABLET, FILM COATED in 1 PACKET (47682-006-99)

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-006

Unifirst First Aid Corporation Medique Decorel Forte Plus 250 PACKET in 1 BOX, UNIT-DOSE (47682-138-13) > 2 TABLET, FILM COATED in 1 PACKET (47682-138-99)

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-138

U

DOH 690-292 May 2016 340 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCUnifirst First Aid Corporation Medique Decorel Forte Plus 50 PACKET in 1 BOX, UNIT-DOSE

(47682-138-33) > 2 TABLET, FILM COATED in 1 PACKET (47682-138-99)

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-138

Unifirst First Aid Corporation Medi-First Cold Relief 250 PACKET in 1 BOX, UNIT-DOSE (47682-139-13) > 2 TABLET, FILM COATED in 1 PACKET (47682-139-99)

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-139


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-139


325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-139

DOH 690-292 May 2016 341 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCUnifirst First Aid Corporation Medi-First Plus Cold Relief 50 PACKET in 1 BOX, UNIT-DOSE

(47682-159-33) > 2 TABLET, FILM COATED in 1 PACKET

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-159

Unifirst First Aid Corporation Medi-First Plus Cold Relief 125 PACKET in 1 BOX, UNIT-DOSE (47682-159-48) > 2 TABLET, FILM COATED in 1 PACKET

325 mg/1, 15 mg/1, 200 mg/1, 5 mg/1


47682-159

UNIFIRST FIRST AID CORPORATION Medique Guaicon DMS 20 PACKET in 1 BOX (47682-217-71) > 10 mL in 1 PACKET

100 mg/5mL, 10 mg/5mL Guaifenesin, Dextromethorphan Hbr

47682-217

Unipharm, Inc. Gripmax 12 TABLET in 1 BLISTER PACK (62900-4012-2)

325 mg/1, 25 mg/1, 10.5 mg/1

Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

62900-4012

United Exchange Corp. Family Care Cold and Flu Nighttime 118 mL in 1 BOTTLE, PLASTIC (65923-629-04)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

Acetaminophen, Dextromethorphan hydrobromide, and Doxylamine succinate

65923-629

United Exchange Corp. Family Care Cold and Flu Multi Symptom 118 mL in 1 BOTTLE, PLASTIC (65923-630-04)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate

65923-630

DOH 690-292 May 2016 342 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCUnited Exchange Corp. Family Care Cold and Flu Multi Symptom 118 mL in 1 BOTTLE, PLASTIC

(65923-627-04)325 mg/15mL, 10 mg/15mL, 5 mg/15mL


65923-627

United Exchange Corp. Family Care Cough Nighttime 118 mL in 1 BOTTLE, PLASTIC (65923-625-04)

30 mg/30mL, 12.5 mg/30mL

Dextromethorphan hydrobromide, and Doxylamine succinate

65923-625

United Exchange Corp. Family Care Cough and Cold 118 mL in 1 BOTTLE (65923-633-04) 40 mg/10mL, 400 mg/10mL Dextromethorphan hydrobromide, and Guaifenesin

65923-633

United Exchange Corp. Family Care Multi Symptom Cold 118 mL in 1 BOTTLE, PLASTIC (65923-632-04)

10 mg/5mL, 100 mg/5mL, 5 mg/5mL

Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine hydrochloride

65923-632

US Pharmaceutical Corporation NorelCS 15 mL in 1 BOTTLE, PLASTIC (52747-480-01)

4 mg/5mL, 12.5 mg/5mL, 10 mg/5mL

Chlorpheniramine Maleate/Dextromethorphan Hydrobromide/Phenylephrine Hydrochloride

52747-480

US Pharmaceutical Corporation NorelCS 473 mL in 1 BOTTLE, PLASTIC (52747-480-90)

4 mg/5mL, 12.5 mg/5mL, 10 mg/5mL

Chlorpheniramine Maleate/Dextromethorphan Hydrobromide/Phenylephrine Hydrochloride

52747-480

VALUE MERCHANDISERS COMPANY, Multi-Symptom Cold 2 BLISTER PACK in 1 CARTON (63941-473-08) > 12 TABLET in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


63941-473V

DOH 690-292 May 2016 343 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCVALUE MERCHANDISERS COMPANY, Multi-Symptom Cold 2 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63941-503

VALUE MERCHANDISERS COMPANY, Severe Multi-Symptom Cold 1 BLISTER PACK in 1 CARTON (63941-053-08) > 24 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


63941-053

VALUE MERCHANDISERS COMPANY, Multi-Symptom Cold 2 BLISTER PACK in 1 CARTON (63941-470-08) > 12 TABLET in 1 BLISTER PACK


63941-470

VALUE MERCHANDISERS COMPANY, Cold and Cough High Blood Pressure 2 BLISTER PACK in 1 CARTON (63941-411-21) > 8 TABLET in 1 BLISTER PACK


63941-411

Velocity Pharma NightTime Cold and Flu 12 CARTON in 1 BLISTER PACK (76168-056-02) > 1 CAPSULE, LIQUID FILLED in 1 CARTON

325 mg/1, 10 mg/1, 6.25 mg/1


76168-056

Velocity Pharma DayTime Cold and Flu 12 CARTON in 1 BLISTER PACK (76168-055-02) > 1 CAPSULE, LIQUID FILLED in 1 CARTON


76168-055

Velocity Pharma Pain Reliever Fever Reducer 6 CARTON in 1 BLISTER PACK (76168-021-13) > 1 TABLET, EFFERVESCENT in 1 CARTON

250 mg/1, 10 mg/1, 5 mg/1, 2 mg/1

Acetaminophen,Dextromethorphan hydrobromide,Phenylephrine Hydrochloride,Chlorpheniramine Maleate

76168-021

Velocity Pharma Cough and Congestion DM 16 CARTON in 1 BOTTLE (76168-060-37) > 1 CAPSULE, LIQUID FILLED in 1CARTON

10 mg/1, 200 mg/1 Dextromethorphan and Guaifenesin

76168-060

DOH 690-292 May 2016 344 of 379


Wakefern Food Corporation ShopRite Childrens Multi Symptom Cold Relief 1 BOTTLE in 1 CARTON (41190-903-26) > 118 mL in 1 BOTTLE



41190-903

Wakefern Food Corporation ShopRite Ni Calm 8 BLISTER PACK in 1 CARTON (41190-977-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41190-977

Wakefern Food Corporation ShopRite Ni Calm 8 BLISTER PACK in 1 CARTON (41190-056-73) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


41190-056

Wakefern Food Corporation ShopRite Ni Calm 237 mL in 1 BOTTLE (41190-335-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


41190-335



41190-335



41190-459



41190-459

Wakefern Food Corporation shoprite ni calm 355 mL in 1 BOTTLE (41190-763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


41190-763

W

DOH 690-292 May 2016 345 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWakefern Food Corporation shoprite day calm severe 12 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41190-548

Wakefern Food Corporation ShopRite Day Calm Severe 355 mL in 1 BOTTLE (41190-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


41190-603

Wakefern Food Corporation ShopRite Severe Cold 2 BLISTER PACK in 1 CARTON (41190-308-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


41190-308

WAKEFERN FOOD CORPORATION ShopRite DayTime Flu Plus Severe Cold And Cough 5 POWDER, FOR SOLUTION in 1 CARTON (41190-112-07)

650 mg/1, 20 mg/1, 10 mg/1


41190-112

Wakefern Food Corporation ShopRite Day Calm 355 mL in 1 BOTTLE (41190-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


41190-656

Wakefern Food Corporation ShopRite Day Calm 8 BLISTER PACK in 1 CARTON (41190-944-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


41190-944

Wakefern Food Corporation ShopRite Childrens Cold and Cough 1 BOTTLE in 1 CARTON (41190-987-26) > 118 mL in 1 BOTTLE



41190-987

Wakefern Food Corporation ShopRite Cough DM 1 BOTTLE in 1 CARTON (41190-384-21) > 89 mL in 1 BOTTLE


Wakefern Food Corporation ShopRite Ni Calm 355 mL in 1 BOTTLE (41190-668-40) 30 mg/30mL, 12.5 mg/30mL


41190-668

DOH 690-292 May 2016 346 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWakefern Food Corporation shoprite adult tussin 1 BOTTLE in 1 CARTON (41190-359-



Wakefern Food Corporation shoprite adult tussin 1 BOTTLE in 1 CARTON (41190-359-34) > 237 mL in 1 BOTTLE


41190-359

Wakefern Food Corporation ShopRite Adult Tussin 1 BOTTLE in 1 CARTON (41190-799-26) > 118 mL in 1 BOTTLE


41190-799


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


41190-516


20 mg/10mL, 200 mg/10mL, 10 mg/10mL


41190-516


20 mg/10mL, 400 mg/10mL, 10 mg/10mL


41190-284

WALGREEN CO. Nighttime Multi-Symptom Cold 2 BLISTER PACK in 1 CARTON (0363-4730-08) > 12 CAPSULE in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


0363-4730

WALGREEN CO. Flu HBP 2 BLISTER PACK in 1 CARTON (0363-0461-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK


0363-0461

WALGREEN CO. Nighttime Multi-Symptom Cold and Flu Relief 1 BLISTER PACK in 1 CARTON (0363-0535-21) > 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


0363-0535

WALGREEN CO. Cold and Flu 2 BLISTER PACK in 1 CARTON (0363-6600-08) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


0363-6600

DOH 690-292 May 2016 347 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWALGREEN CO. Cold and Flu 2 BLISTER PACK in 1 CARTON (0363-


325 mg/1, 15 mg/1, 6.25 mg/1


0363-6600

WALGREEN CO. Cold and Flu 2 BLISTER PACK in 1 CARTON (0363-6770-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


0363-6770

WALGREEN CO. Severe Cold 3 BLISTER PACK in 1 CARTON (0363-0503-07) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-0503

WALGREEN CO. Severe Cold 2 BLISTER PACK in 1 CARTON (0363-0503-08) > 12 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-0503

WALGREEN CO. Mucus Relief Plus 1 BOTTLE in 1 CARTON (0363-0372-01) > 30 TABLET, FILM COATED in 1BOTTLE

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-0372

WALGREEN CO. Mucus Relief Plus 1 BOTTLE, PLASTIC in 1 CARTON (0363-0372-10) > 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-0372

WALGREEN CO. Mucus Relief 2 BLISTER PACK in 1 PACKAGE (0363-0616-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-0616

DOH 690-292 May 2016 348 of 379


0640-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-0640

WALGREEN CO. Wal-Phed PE 2 BLISTER PACK in 1 CARTON (0363-5460-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


0363-5460

WALGREEN CO. Mucus Relief 2 BLISTER PACK in 1 PACKAGE (0363-6170-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-6170

WALGREEN CO. Walgreens Severe Cold Multi-Symptom For Adults 1 BOTTLE in 1 CARTON (0363-8591-20) > 240 mL in 1 BOTTLE



0363-8591

WALGREEN CO. Walgreens Severe Warming Cold and Flu For Adults 1 BOTTLE in 1 CARTON (0363-8592-20) > 240 mL in 1 BOTTLE


acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride

0363-8592

WALGREEN CO. Walgreens Daytime non-drowsy cold multi-symptom for adults


325 mg/15mL, 10 mg/15mL, 5 mg/15mL

acetaminophen, phenylephrine hydrochloride and dextromethorphan hydrobromide

0363-8589

WALGREEN CO. Cold and Flu 2 BLISTER PACK in 1 CARTON (0363-6590-08) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


0363-6590

DOH 690-292 May 2016 349 of 379




0363-6590

WALGREEN CO. Wal-Phed 2 BLISTER PACK in 1 CARTON (0363-5110-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK


0363-5110

Walgreen Co. Walgreens Daytime Wal-Flu Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (0363-1100-06)

650 mg/1, 20 mg/1, 10 mg/1


0363-1100

WALGREEN CO. Multi-Symptom Cold Warming Effect Daytime 1 BLISTER PACK in 1 CARTON (0363-0106-08) > 24 CAPSULE in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan HBr, Phenylepherine

0363-0106

WALGREEN CO. Cold Multi-Symptom Daytime Non-Drowsy 1 BLISTER PACK in 1 BOX (0363-0470-08) > 24 TABLET in 1 BLISTER PACK


0363-0470

WALGREEN CO. Cold 2 BLISTER PACK in 1 CARTON (0363-0560-08) > 12 TABLET in 1 BLISTER PACK


0363-0560

WALGREEN CO. Daytime Multi-Symptom Non-Drowsy Cold and Flu 2 BLISTER PACK in 1 CARTON (0363-0534-21) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


0363-0534

WALGREEN CO. Multi-Symptom Nighttime Cold 1 BLISTER PACK in 1 CARTON (0363-0591-08) > 24 CAPSULE, GELATIN COATED in 1 BLISTER PACK


0363-0591

WALGREEN CO. Wal-Tussin 1 BOTTLE, PLASTIC in 1 PACKAGE (0363-6610-09) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC


DOH 690-292 May 2016 350 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWALGREEN CO. Non-Drowsy Formula Wal-Tussin 1 BOTTLE in 1 PACKAGE (0363-0244-

09) > 20 CAPSULE, GELATINCOATED in 1 BOTTLE


WALGREEN CO. Mucus Relief Severe Congestion and Cough 2 BLISTER PACK in 1 CARTON (0363-6480-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK

10 mg/1, 200 mg/1, 5 mg/1 Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

0363-6480

WALGREEN CO. Mucus Relief DM 3 BLISTER PACK in 1 CARTON (0363-0533-01) > 10 TABLET in 1 BLISTER PACK


0363-0533

WALGREEN CO. Mucus Relief DM 1 BOTTLE in 1 CARTON (0363-0533-11) > 60 TABLET in 1 BOTTLE


0363-0533

WALGREEN CO. Mucus Relief DM 2 BOTTLE in 1 CARTON (0363-0533-32) > 120 TABLET in 1 BOTTLE


0363-0533

Walgreen Company cold and cough 237 mL in 1 BOTTLE (0363-0698-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

0363-0698

Walgreen Company Cold and Flu 237 mL in 1 BOTTLE (0363-0566-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0363-0566



0363-0566

Walgreen Company Cold and Flu 2 BOTTLE in 1 PACKAGE (0363-0566-50) > 355 mL in 1 BOTTLE (0363-0566-40)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0363-0566

Walgreen Company nighttime cold and flu relief 177 mL in 1 BOTTLE (0363-0459-30) 325 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0363-0459

DOH 690-292 May 2016 351 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company nighttime cold and flu relief 296 mL in 1 BOTTLE (0363-0459-38) 325 mg/15mL, 15


0363-0459



0363-0459



0363-0459



0363-0401



0363-0401

Walgreen Company Walgreen Nighttime 177 mL in 1 BOTTLE (0363-0041-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0363-0041



0363-0041



0363-0041

DOH 690-292 May 2016 352 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company Walgreen Nighttime 473 mL in 1 BOTTLE (0363-0041-43) 500 mg/15mL, 15

mg/15mL, 6.25 mg/15mLacetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid

0363-0041



0363-0335



0363-0335



0363-0335

Walgreen Company nighttime cold and flu relief 2 BLISTER PACK in 1 CARTON (0363-1005-01) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate

0363-1005

Walgreen Company nighttime cold and flu relief 2 BLISTER PACK in 1 CARTON (0363-1005-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate

0363-1005

Walgreen Company cold and flu relief 355 mL in 1 BOTTLE (0363-0872-40) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0363-0872

Walgreen Company Nighttime 177 mL in 1 BOTTLE (0363-0908-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0363-0908

DOH 690-292 May 2016 353 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company Nighttime 2 BOTTLE in 1 PACKAGE (0363-0908-



0363-0908



0363-0908



0363-0908



0363-0917

Walgreen Company Cold and Flu 2 BOTTLE in 1 PACKAGE (0363-0917-50) > 355 mL in 1 BOTTLE

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


0363-0917

Walgreen Company Nighttime Cold and Flu Relief 296 mL in 1 BOTTLE (0363-0990-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0363-0990

Walgreen Company Nighttime Cold and Flu Relief 355 mL in 1 BOTTLE (0363-0990-40) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


0363-0990

Walgreen Company Severe Cold and Flu 355 mL in 1 BOTTLE (0363-0763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


0363-0763

DOH 690-292 May 2016 354 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company severe cold and flu 355 mL in 1 BOTTLE (0363-0623-40) 650 mg/30mL, 20

mg/30mL, 12.5 mg/30mL, 10 mg/30mL


0363-0623

Walgreen Company Nighttime D 296 mL in 1 BOTTLE (0363-0609-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL, 30 mg/15mL


0363-0609

Walgreen Company Cold and Flu Nighttime D 355 mL in 1 BOTTLE (0363-0807-40) 1000 mg/30mL, 30 mg/30mL, 12.5 mg/30mL, 60 mg/30mL


0363-0807



0363-0550



0363-0550

Walgreen Company Severe Cold and Flu 355 mL in 1 BOTTLE (0363-0603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


0363-0603

Walgreen Company Severe Cold and Flu 12 BLISTER PACK in 1 CARTON (0363-0839-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


0363-0839

DOH 690-292 May 2016 355 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company Daytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (0363-


325 mg/1, 10 mg/1, 5 mg/1 acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

0363-1000

Walgreen Company Daytime Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (0363-1000-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


0363-1000

Walgreen Company Daytime Cold and Flu Relief 4 BLISTER PACK in 1 CARTON (0363-1003-03) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


0363-1003

Walgreen Company Daytime Cold and Flu Relief 177 mL in 1 BOTTLE (0363-0656-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


0363-0656



0363-0656



0363-0656



0363-0656

Walgreen Company Cold and Flu 237 mL in 1 BOTTLE (0363-0666-34) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


0363-0666

DOH 690-292 May 2016 356 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company Cold and Flu 355 mL in 1 BOTTLE (0363-0666-40) 325 mg/15mL, 10


0363-0666

Walgreen Company wal flu severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (0363-0096-91)

650 mg/1, 20 mg/1, 10 mg/1


0363-0096

Walgreen Company childrens wal tap 1 BOTTLE in 1 CARTON (0363-0708-26) > 118 mL in 1 BOTTLE



0363-0708

Walgreen Company childrens wal tap dm 1 BOTTLE in 1 CARTON (0363-0987-26) > 118 mL in 1 BOTTLE



0363-0987

Walgreen Company Cough DM 1 BOTTLE in 1 CARTON (0363-0958-21) > 89 mL in 1 BOTTLE




Walgreen Company childrens cough dm 1 BOTTLE in 1 CARTON (0363-0899-21) > 89 mL in 1 BOTTLE


Walgreen Company Cough Relief 296 mL in 1 BOTTLE (0363-0689-38) 15 mg/15mL Dextromethorphan HBr 0363-0689

Walgreen Company Cough Relief 355 mL in 1 BOTTLE (0363-0689-40) 15 mg/15mL Dextromethorphan HBr 0363-0689

Walgreen Company daytime cough 296 mL in 1 BOTTLE (0363-0473-38) 15 mg/15mL Dextromethorphan HBr 0363-0473



Walgreen Company Cough 355 mL in 1 BOTTLE (0363-0500-40) 15 mg/15mL Dextromethorphan HBr 0363-0500

DOH 690-292 May 2016 357 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company Adult Wal Tussin 1 BOTTLE in 1 CARTON (0363-0300-

26) > 118 mL in 1 BOTTLE30 mg/10mL Dextromethorphan

Hydrobromide0363-0300





Walgreen Company Nighttime Cough 177 mL in 1 BOTTLE (0363-0668-30) 15 mg/15mL, 6.25 mg/15mL


0363-0668

Walgreen Company Nighttime Cough 296 mL in 1 BOTTLE (0363-0668-38) 15 mg/15mL, 6.25 mg/15mL


0363-0668

Walgreen Company cough relief 237 mL in 1 BOTTLE (0363-0588-34) 30 mg/30mL, 12.5 mg/30mL


0363-0588

Walgreen Company cough relief 355 mL in 1 BOTTLE (0363-0588-40) 30 mg/30mL, 12.5 mg/30mL


0363-0588

Walgreen Company Cough 237 mL in 1 BOTTLE (0363-0019-34) 30 mg/30mL, 12.5 mg/30mL


0363-0019

Walgreen Company Cough 355 mL in 1 BOTTLE (0363-0019-40) 30 mg/30mL, 12.5 mg/30mL


0363-0019

Walgreen Company wal tussin dm 1 BOTTLE in 1 CARTON (0363-0578-26) > 118 mL in 1 BOTTLE


0363-0578



0363-0578

Walgreen Company Wal Tussin 1 BOTTLE in 1 CARTON (0363-0359-26) > 118 mL in 1 BOTTLE


0363-0359



0363-0359

DOH 690-292 May 2016 358 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company Wal Tussin 1 BOTTLE in 1 CARTON (0363-0359-



Walgreen Company Cough 1 BOTTLE in 1 CARTON (0363-0419-26) > 118 mL in 1 BOTTLE


0363-0419



0363-0396



0363-0396



0363-0396

Walgreen Company Mucus Relief DM 1 BOTTLE in 1 CARTON (0363-0735-30) > 28 TABLET, EXTENDEDRELEASE in 1 BOTTLE


0363-0735



0363-0735



0363-0735

Walgreen Company wal tussin dm max 1 BOTTLE in 1 CARTON (0363-0702-26) > 118 mL in 1 BOTTLE


0363-0702

Walgreen Company wal tussin dm max 1 BOTTLE in 1 CARTON (0363-0702-34) > 237 mL in 1 BOTTLE


0363-0702

Walgreen Company daytime 295 mL in 1 BOTTLE (0363-0818-38) 10 mg/15mL, 200 mg/15mL Dextromethorphan HBr, Guaifenesin

0363-0818

Walgreen Company wal tussin 1 BOTTLE in 1 CARTON (0363-0799-26) > 118 mL in 1 BOTTLE


0363-0799

Walgreen Company wal tussin 1 BOTTLE in 1 CARTON (0363-0799-34) > 237 mL in 1 BOTTLE


0363-0799

DOH 690-292 May 2016 359 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreen Company wal tussin dm max 1 BOTTLE in 1 CARTON (0363-0934-

26) > 118 mL in 1 BOTTLE20 mg/10mL, 400 mg/10mL dextromethorphan hbr,

guaifenesin0363-0934

Walgreen Company childrens multi symptom cold 1 BOTTLE in 1 CARTON (0363-9839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


0363-9839

Walgreen Company wal tussin cf 1 BOTTLE in 1 CARTON (0363-0704-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


0363-0704

Walgreen Company wal tussin cf 1 BOTTLE in 1 CARTON (0363-0704-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


0363-0704

Walgreen Company wal tussin cf max 1 BOTTLE in 1 CARTON (0363-0296-26) > 118 mL in 1 BOTTLE

10 mg/5mL, 200 mg/5mL, 5 mg/5mL


0363-0296


10 mg/5mL, 100 mg/5mL, 5 mg/5mL


0363-0516


10 mg/5mL, 100 mg/5mL, 5 mg/5mL


0363-0516


10 mg/5mL, 100 mg/5mL, 5 mg/5mL


0363-0516

Walgreens Childrens Plus Cough and Runny Nose 1 BOTTLE, PLASTIC in 1 BOX (0363-0297-04) > 118 mL in 1 BOTTLE, PLASTIC



0363-0297

DOH 690-292 May 2016 360 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreens Childrens Plus Flu 1 BOTTLE, PLASTIC in 1 BOX (0363-

0030-04) > 118 mL in 1 BOTTLE, PLASTIC



0363-0030

Walgreens Childrens Plus Multi Symptom Cold 1 BOTTLE, PLASTIC in 1 BOX (0363-0034-04) > 118 mL in 1 BOTTLE, PLASTIC



0363-0034

Walgreens Cough and Sore Throat 1 BOTTLE, PLASTIC in 1 BOX (0363-0029-04) > 118 mL in 1 BOTTLE, PLASTIC

160 mg/5mL, 5 mg/5mL Acetaminophen, Dextromethorphan hydrobromide

0363-0029

Walgreens Childrens Plus Cough and Sore Throat 118 mL in 1 BOTTLE, PLASTIC (0363-0442-44)

160 mg/5mL, 5 mg/5mL Acetaminophen,DEXTROMETHORPHAN HYDROBROMIDE

0363-0442

Walgreens Cough Cold and Sore Throat 1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04) > 118 mL in 1 BOTTLE, PLASTIC



0363-4050

Walgreens Flu Relief Therapy 245 mL in 1 BOTTLE, PLASTIC (0363-2104-08)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


0363-2104

Walgreens COLD and FLU 2 BLISTER PACK in 1 CARTON (0363-9892-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 200 mg/1, 10 mg/1, 5 mg/1

ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

0363-9892

DOH 690-292 May 2016 361 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWalgreens Mucus Relief Severe Cold 177 mL in 1 BOTTLE, PLASTIC (0363-

0410-06)20 mg/20mL, 650 mg/20mL, 400 mg/20mL, 10 mg/20mL


0363-0410

Walgreens Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (0363-3360-06)



0363-3360

Walgreens Cough and Chest Congestion DM 177 mL in 1 BOTTLE, PLASTIC (0363-0506-06)


0363-0506

Walgreens Cough and Chest Congestion DM 177 mL in 1 BOTTLE, PLASTIC (0363-0417-06)


0363-0417

Walgreens Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (0363-3380-06)


0363-3380

Walgreens Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (0363-0337-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


0363-0337

Walgreens Triacting Daytime Cold Cough 1 BOTTLE, PLASTIC in 1 BOX (0363-3780-04) > 118 mL in 1 BOTTLE, PLASTIC


0363-3780

Walgreens MUCUS RELIEF DM 3 BLISTER PACK in 1 CARTON (0363-9891-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

400 mg/1, 20 mg/1 GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE

0363-9891

Walgreens Co. Well At Walgreens Multi-Symptom Severe Cold 6 GRANULE, FOR SOLUTION in 1 BOX (0363-1104-06)

500 mg/1, 20 mg/1, 10 mg/1


0363-1104

DOH 690-292 May 2016 362 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWal-Mart Stores Inc Nighttime 296 mL in 1 BOTTLE (49035-041-38) 500 mg/15mL, 15


49035-041

Wal-Mart Stores Inc Equate NiteTime 12 BLISTER PACK in 1 CARTON (49035-056-62) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49035-056

Wal-Mart Stores Inc equate nitetime 296 mL in 1 BOTTLE (49035-335-38) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49035-335



49035-335



49035-335



49035-459



49035-459



49035-459

Wal-Mart Stores Inc equate nitetime 2 BOTTLE in 1 CARTON (49035-459-50) > 355 mL in 1 BOTTLE

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


49035-459

DOH 690-292 May 2016 363 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWal-Mart Stores Inc equate nitetime 2 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


49035-977

Wal-Mart Stores Inc equate nitetime 2 BLISTER PACK in 1 CARTON (49035-977-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49035-977

Wal-Mart Stores Inc NiteTime Cold/Flu, Multi-Symptom Relief 2 BLISTER PACK in 1 PACKAGE (49035-978-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


49035-978

Wal-Mart Stores Inc equate nite time 296 mL in 1 BOTTLE (49035-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


49035-908

Wal-Mart Stores Inc equate nitetime severe 355 mL in 1 BOTTLE (49035-763-40) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


49035-763

Wal-Mart Stores Inc Equate DayTime Severe 355 mL in 1 BOTTLE (49035-603-40) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


49035-603

Wal-Mart Stores Inc Multi-Symptom Cold Flu and Sore Throat 3 BLISTER PACK in 1 PACKAGE (49035-616-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49035-616

Wal-Mart Stores Inc Severe Cold Multi-Symptom 1 BLISTER PACK in 1 CARTON (49035-503-08) > 24 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49035-503

DOH 690-292 May 2016 364 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWal-Mart Stores Inc equate daytime severe 12 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


49035-548

Wal-Mart Stores Inc Cold and Flu 2 BLISTER PACK in 1 CARTON (49035-053-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl

49035-053

Wal-Mart Stores Inc equate flu and severe cold and cough 6 POWDER, FOR SOLUTION in 1 CARTON (49035-096-91)

650 mg/1, 20 mg/1, 10 mg/1


49035-096

Wal-Mart Stores Inc equate daytime 4 BLISTER PACK in 1 CARTON (49035-215-58) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


49035-215



49035-215



49035-215

Wal-Mart Stores Inc Cold Multi-Symptom 2 BLISTER PACK in 1 CARTON (49035-560-08) > 12 TABLET in 1 BLISTER PACK

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl

49035-560

DOH 690-292 May 2016 365 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWal-Mart Stores Inc Equate Day time 296 mL in 1 BOTTLE (49035-656-38) 325 mg/15mL, 10


49035-656

Wal-Mart Stores Inc Equate Day time 355 mL in 1 BOTTLE (49035-656-40) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


49035-656

Wal-Mart Stores Inc Cold and Flu 4 BLISTER PACK in 1 CARTON (49035-659-22) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


49035-659



49035-994



49035-994

Wal-Mart Stores Inc equate childrens cold and cough 1 BOTTLE in 1 CARTON (49035-082-34) > 237 mL in 1 BOTTLE



49035-082

Wal-Mart Stores Inc equate cough dm 1 BOTTLE in 1 CARTON (49035-899-28) > 148 mL in 1 BOTTLE


Wal-Mart Stores Inc Equate Cough DM 1 BOTTLE in 1 CARTON (49035-384-21) > 89 mL in 1 BOTTLE






DOH 690-292 May 2016 366 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWal-Mart Stores Inc Equate Nite Time 296 mL in 1 BOTTLE (49035-668-38) 30 mg/30mL, 12.5

mg/30mLDextromethorphan Hydrobromide, Doxylamine Succinate

49035-668

Wal-Mart Stores Inc Equate Nite Time 355 mL in 1 BOTTLE (49035-668-40) 30 mg/30mL, 12.5 mg/30mL


49035-668

Wal-Mart Stores Inc Equate Tussin DM Max 1 BOTTLE in 1 CARTON (49035-799-26) > 118 mL in 1 BOTTLE


49035-799

Wal-Mart Stores Inc Equate Tussin DM 1 BOTTLE in 1 CARTON (49035-359-26) > 118 mL in 1 BOTTLE


49035-359

Wal-Mart Stores Inc Equate Tussin DM 1 BOTTLE in 1 CARTON (49035-359-34) > 237 mL in 1 BOTTLE


49035-359

Wal-Mart Stores Inc Equate Tussin CF 1 BOTTLE in 1 CARTON (49035-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49035-516

Wal-Mart Stores Inc Equate Tussin CF 1 BOTTLE in 1 CARTON (49035-516-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


49035-516

We Care Distributor Inc. NIGHTTIME COLD AND FLU 2 POUCH in 1 POUCH (70005-005-02) > 2 CAPSULE, LIQUID FILLED in 1POUCH

325 mg/1, 15 mg/1, 6.25 mg/1

Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 325 mg, 15 mg and 6.25 mg

70005-005

We Care Distributor Inc. NIGHTTIME COLD AND FLU 25 POUCH in 1 BOX (70005-005-25) > 2 CAPSULE, LIQUID FILLED in 1POUCH

325 mg/1, 15 mg/1, 6.25 mg/1


70005-005

DOH 690-292 May 2016 367 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWe Care Distributor Inc. NIGHTTIME COLD AND FLU 50 POUCH in 1 BOX (70005-005-50)

> 2 CAPSULE, LIQUID FILLED in 1POUCH

325 mg/1, 15 mg/1, 6.25 mg/1


70005-005

We Care Distributor Inc. DAYTIME COLD AND FLU 2 POUCH in 1 POUCH (70005-003-02) > 2 CAPSULE, LIQUID FILLED in 1POUCH

325 mg/1, 10 mg/1, 5 mg/1 Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl 325 mg, 10 mg and 5 mg

70005-003

We Care Distributor Inc. DAYTIME COLD AND FLU 25 POUCH in 1 BOX (70005-003-25) > 2 CAPSULE, LIQUID FILLED in 1POUCH


70005-003

We Care Distributor Inc. DAYTIME COLD AND FLU 50 POUCH in 1 BOX (70005-003-50) > 2 CAPSULE, LIQUID FILLED in 1POUCH


70005-003

Western Family Foods Inc multi symptom cold plus 1 BOTTLE in 1 CARTON (55312-903-26) > 118 mL in 1 BOTTLE



55312-903

Western Family Foods Inc Cold Relief 2 BLISTER PACK in 1 CARTON (55312-393-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55312-393

DOH 690-292 May 2016 368 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods Inc cold relief 2 BLISTER PACK in 1 CARTON


325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


55312-014

Western Family Foods Inc Childrens Cough Plus 1 BOTTLE in 1 CARTON (55312-196-26) > 118 mL in 1 BOTTLE


55312-196

Western Family Foods Inc cough and sore throat 237 mL in 1 BOTTLE (55312-698-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

55312-698

Western Family Foods Inc cold and cough daytime 237 mL in 1 BOTTLE (55312-700-34) 500 mg/15mL, 15 mg/15mL Acetaminophen, Dextromethorphan HBr

55312-700

Western Family Foods Inc NightRelief Free 177 mL in 1 BOTTLE (55312-908-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55312-908

Western Family Foods Inc NightRelief Free 296 mL in 1 BOTTLE (55312-908-38) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55312-908

Western Family Foods Inc NightRelief Free 2 BOTTLE in 1 PACKAGE (55312-908-40) > 177 mL in 1 BOTTLE

500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55312-908

Western Family Foods Inc night relief 6 BLISTER PACK in 1 CARTON (55312-977-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55312-977

Western Family Foods Inc night relief 8 BLISTER PACK in 1 CARTON (55312-977-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


55312-977

DOH 690-292 May 2016 369 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods Inc night relief free 177 mL in 1 BOTTLE (55312-459-30) 650 mg/30mL, 30


55312-459

Western Family Foods Inc night relief free 237 mL in 1 BOTTLE (55312-459-34) 650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


55312-459



55312-459



55312-459

Western Family Foods Inc cold and cough 237 mL in 1 BOTTLE (55312-666-34) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55312-666

Western Family Foods inc Night Relief Free 177 mL in 1 BOTTLE (55312-041-30) 500 mg/15mL, 15 mg/15mL, 6.25 mg/15mL


55312-041



55312-041



55312-041

DOH 690-292 May 2016 370 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods Inc night relief 8 BLISTER PACK in 1 CARTON


325 mg/1, 15 mg/1, 6.25 mg/1


55312-056



55312-335



55312-335



55312-335



55312-335

Western Family Foods Inc allergy and cough 10 BLISTER PACK in 1 CARTON (55312-345-60) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 6.25 mg/1, 5 mg/1


55312-345

Western Family Foods Inc nitetime severe cold and flu relief 237 mL in 1 BOTTLE (55312-763-34) 650 mg/30mL, 20 mg/30mL, 12.5 mg/30mL, 10 mg/30mL


55312-763

Western Family Foods Inc Mucus Relief 2 BLISTER PACK in 1 CARTON (55312-922-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55312-922

DOH 690-292 May 2016 371 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods Inc Mucus Relief 10 BLISTER PACK in 1 CARTON


325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55312-381

Western Family Foods Inc DayTime Severe Cold and Flu Relief 237 mL in 1 BOTTLE (55312-603-34) 325 mg/15mL, 10 mg/15mL, 200 mg/15mL, 5 mg/15mL


55312-603

Western Family Foods Inc Mucus Relief 10 BLISTER PACK in 1 PACKAGE (55312-025-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55312-025

Western Family Foods Inc cold relief 2 BLISTER PACK in 1 CARTON (55312-308-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55312-308

Western Family Foods Inc cold relief 12 BLISTER PACK in 1 CARTON (55312-234-62) > 2 TABLET, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


55312-234

Western Family Foods Inc Flu and Severe Cold and Cough 6 POWDER, FOR SOLUTION in 1 CARTON (55312-096-91)

650 mg/1, 20 mg/1, 10 mg/1


55312-096

Western Family Foods Inc day relief pe 1 BLISTER PACK in 1 CARTON (55312-215-53) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55312-215

DOH 690-292 May 2016 372 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods Inc day relief pe 2 BLISTER PACK in 1 CARTON



55312-215

Western Family Foods Inc DayRelief 177 mL in 1 BOTTLE (55312-656-30) 325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55312-656



55312-656



55312-656



55312-656

Western Family Foods Inc Cold Relief 2 BLISTER PACK in 1 CARTON (55312-371-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


55312-371

Western Family Foods Inc cold relief 2 BLISTER PACK in 1 CARTON (55312-402-62) > 12 TABLET, FILM COATED in 1 BLISTER PACK


55312-402

Western Family Foods Inc dayrelief pe 12 BLISTER PACK in 1 CARTON (55312-994-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


55312-994

DOH 690-292 May 2016 373 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods Inc dayrelief pe 8 BLISTER PACK in 1 CARTON



55312-994

Western Family Foods Inc adult tussin cough 1 BOTTLE in 1 CARTON (55312-300-26) > 118 mL in 1 BOTTLE


55312-300

Western Family Foods Inc 12 Hour Cough Relief 1 BOTTLE in 1 CARTON (55312-958-21) > 89 mL in 1 BOTTLE


Western Family Foods Inc 12 hour cough relief 1 BOTTLE in 1 CARTON (55312-384-21) > 89 mL in 1 BOTTLE


Western Family Foods Inc Night Relief Cough 177 mL in 1 BOTTLE (55312-668-30) 30 mg/30mL, 12.5 mg/30mL


55312-668

Western Family Foods Inc Night Relief Cough 237 mL in 1 BOTTLE (55312-668-34) 30 mg/30mL, 12.5 mg/30mL


55312-668

Western Family Foods Inc Childrens mucus relief 1 BOTTLE in 1 CARTON (55312-608-26) > 118 mL in 1 BOTTLE


55312-608

Western Family Foods Inc tussin dm 1 BOTTLE in 1 CARTON (55312-578-26) > 118 mL in 1 BOTTLE


55312-578

Western Family Foods Inc expectorant cough 1 BOTTLE in 1 CARTON (55312-419-26) > 118 mL in 1 BOTTLE


55312-419

Western Family Foods Inc tussin 1 BOTTLE in 1 CARTON (55312-359-26) > 118 mL in 1 BOTTLE


55312-359

Western Family Foods Inc tussin 1 BOTTLE in 1 CARTON (55312-359-34) > 237 mL in 1 BOTTLE


55312-359

Western Family Foods Inc Adult Tussin DM Max 1 BOTTLE in 1 CARTON (55312-799-26) > 118 mL in 1 BOTTLE


55312-799

DOH 690-292 May 2016 374 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods Inc day relief 296 mL in 1 BOTTLE (55312-818-38) 10 mg/15mL, 200 mg/15mL Dextromethorphan HBr,


Western Family Foods Inc childrens mucus relief multi symptom cold 1 BOTTLE in 1 CARTON (55312-839-26) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


55312-839

Western Family Foods Inc Tussin CF 1 BOTTLE in 1 CARTON (55312-516-26) > 118 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


55312-516

Western Family Foods Inc Tussin CF 1 BOTTLE in 1 CARTON (55312-516-34) > 237 mL in 1 BOTTLE

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


55312-516

Western Family Foods Inc. Mucus Relief DM Max 177 mL in 1 BOTTLE, PLASTIC (55312-232-06)


55312-232

Western Family Foods, Inc. DayRelief 355 mL in 1 BOTTLE, PLASTIC (55312-066-12)

325 mg/15mL, 10 mg/15mL, 5 mg/15mL


55312-066

Western Family Foods, Inc. Cough Relief Grape 1 BOTTLE, PLASTIC in 1 BOX (55312-038-04) > 118 mL in 1 BOTTLE,PLASTIC


Western Family Foods, Inc. Cough Relief 1 BOTTLE, PLASTIC in 1 BOX (55312-039-04) > 118 mL in 1 BOTTLE,PLASTIC


Western Family Foods, Inc. Mucus Relief 177 mL in 1 BOTTLE, PLASTIC (55312-336-06)



55312-336

DOH 690-292 May 2016 375 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWestern Family Foods, Inc. Tussin DM 1 BOTTLE, PLASTIC in 1 BOX (55312-



55312-385

Western Family Foods, Inc. Expectorant Tab DM 1 BOTTLE in 1 BOX (55312-109-30) > 30 TABLET in 1 BOTTLE


55312-109

Western Family Foods, Inc. Mucus Relief Severe Congestion and Cough 177 mL in 1 BOTTLE, PLASTIC (55312-037-06)

20 mg/20mL, 400 mg/20mL, 10 mg/20mL


55312-037

Western Family Foods, Inc. Tussin CF 1 BOTTLE, PLASTIC in 1 BOX (55312-382-08) > 237 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL

Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI

55312-382

Western Family Foods, Inc. Mucus Relief Cold, Flu and Sore Throat 177 mL in 1 BOTTLE, PLASTIC (55312-233-06)



55312-233

WinCo Foods, LLC Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (67091-206-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

325 mg/1, 15 mg/1, 6.25 mg/1


67091-206

WinCo Foods, LLC Cold and Flu Relief 237 mL in 1 BOTTLE, PLASTIC (67091-258-23)

650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


67091-258


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


67091-258

DOH 690-292 May 2016 376 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWinCo Foods, LLC Cold and Flu Relief 237 mL in 1 BOTTLE, PLASTIC

(67091-260-23)650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


67091-260


650 mg/30mL, 30 mg/30mL, 12.5 mg/30mL


67091-260

WinCo Foods, LLC Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (67091-288-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


67091-288

WinCo Foods, LLC Cold and Flu Relief 2 BLISTER PACK in 1 CARTON (67091-211-24) > 12 TABLET in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


67091-211

WinCo Foods, LLC WinCo Foods Daytime Severe Cold and Cough 6 GRANULE, FOR SOLUTION in 1 BOX (67091-142-06)

650 mg/1, 20 mg/1, 10 mg/1


67091-142

WinCo Foods, LLC Cold and Flu Relief 24 BLISTER PACK in 1 CARTON (67091-205-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK


67091-205


325 mg/15mL, 10 mg/15mL, 5 mg/15mL


67091-257

DOH 690-292 May 2016 377 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWinCo Foods, LLC Childrens Multi-Symptom Cold and Fever Relief 1 BOTTLE in 1 CARTON (67091-221-

18) > 118 mL in 1 BOTTLE325 mg/10mL, 10 mg/10mL, 5 mg/10mL, 200 mg/10mL


67091-221

WinCo Foods, LLC Tussin DM Cough and Chest 1 BOTTLE, PLASTIC in 1 BOX (67091-265-18) > 118 mL in 1 BOTTLE,PLASTIC


67091-265

WinCo Foods, LLC Tussin CF 1 BOTTLE, PLASTIC in 1 BOX (67091-266-18) > 118 mL in 1 BOTTLE,PLASTIC

20 mg/10mL, 200 mg/10mL, 10 mg/10mL


67091-266

WinCo Foods, LLC Childrens Multi-symptom Cold 1 BOTTLE in 1 CARTON (67091-220-18) > 118 mL in 1 BOTTLE

5 mg/5mL, 100 mg/5mL, 2.5 mg/5mL


67091-220

WOONSOCKET PRESCRIPTION CENTEHead Congestion Cold Relief 1 BLISTER PACK in 1 CARTON (59779-473-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 2 mg/1, 10 mg/1, 5 mg/1


59779-473

WOONSOCKET PRESCRIPTION CENTEHead Congestion Cold Relief 1 BLISTER PACK in 1 CARTON (59779-470-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK


59779-470

WOONSOCKET PRESCRIPTION CENTESEVERE COLD AND FLU RELIEF 2 BLISTER PACK in 1 CARTON (59779-889-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1

Acetaminophen, Dextromethorphan HBr, Guiafenesin, Phenylephrine HCl

59779-889

WOONSOCKET PRESCRIPTION CENTECold, Flu and Sore Throat 3 BLISTER PACK in 1 PACKAGE (59779-916-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


59779-916

DOH 690-292 May 2016 378 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWOONSOCKET PRESCRIPTION CENTENon Drowsy Cold and Cough PE 1 BLISTER PACK in 1 CARTON

(59779-799-03) > 10 CAPSULE, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


59779-799

WOONSOCKET PRESCRIPTION CENTENon Drowsy Cold and Cough PE 1 BLISTER PACK in 1 CARTON (59779-799-09) > 20 CAPSULE, COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


59779-799

WOONSOCKET PRESCRIPTION CENTESevere Congestion and Cold 3 BLISTER PACK in 1 PACKAGE (59779-761-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


59779-761

WOONSOCKET PRESCRIPTION CENTESevere Congestion and Cold 2 BLISTER PACK in 1 PACKAGE (59779-761-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 200 mg/1, 5 mg/1


59779-761

WOONSOCKET PRESCRIPTION CENTESinus PE Pressure, Pain and Cold 2 BLISTER PACK in 1 CARTON (59779-599-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

325 mg/1, 10 mg/1, 100 mg/1, 5 mg/1


59779-599

WOONSOCKET PRESCRIPTION CENTECold Relief 2 BLISTER PACK in 1 CARTON (59779-560-08) > 12 TABLET in 1 BLISTER PACK


59779-560

WOONSOCKET PRESCRIPTION CENTESinus PE Pressure, Pain plus Cough 2 BLISTER PACK in 1 CARTON (59779-555-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK


59779-555

WOONSOCKET PRESCRIPTION CENTELong Acting Tussin Cough Gels 1 BOTTLE in 1 PACKAGE (59779-442-09) > 20 CAPSULE, GELATINCOATED in 1 BOTTLE


DOH 690-292 May 2016 379 of 379

Labeler Name Proprietary Name Package Description Strength Non-Proprietary Name Product NDCWOONSOCKET PRESCRIPTION CENTETussin Cough 1 BOTTLE in 1 PACKAGE (59779-662-

09) > 20 CAPSULE, LIQUID FILLED in1 BOTTLE


Zee Medical Inc Cough Syrup DM 6 PACKET in 1 CARTON (35418-119-37) > 10 mL in 1 PACKET (35418-119-42)

10 mg/5mL, 100 mg/5mL Guaifenesin, Dextromethorpham HBr

35418-119Z

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