NDC 0031-8765

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief

Dextromethorphan Hydrobromide, Guaifenesin

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Wyeth Consumer Healthcare Llc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID0031-8765_085965c3-0c8c-4318-aa28-f6b509b5f573
NDC0031-8765
Product TypeHuman Otc Drug
Proprietary NameRobitussin Maximum Strength 12 Hour Cough and Mucus Relief
Generic NameDextromethorphan Hydrobromide, Guaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-06-14
Marketing CategoryANDA / ANDA
Application NumberANDA207602
Labeler NameWyeth Consumer Healthcare LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength60 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0031-8765-04

1 BLISTER PACK in 1 CARTON (0031-8765-04) > 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2019-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8765-04 [00031876504]

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207602
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-14

NDC 0031-8765-08 [00031876508]

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207602
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-14

NDC 0031-8765-16 [00031876516]

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207602
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-14

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1

OpenFDA Data

SPL SET ID:96409b52-b0ec-444b-bc39-fd41070e9855
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099074

    • NDC Crossover Matching brand name "Robitussin Maximum Strength 12 Hour Cough and Mucus Relief" or generic name "Dextromethorphan Hydrobromide, Guaifenesin"

    NDCBrand NameGeneric Name
    0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, Guaifenesin
    0363-1603adult tussin dmdextromethorphan hydrobromide, guaifenesin
    0280-0089Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizzdextromethorphan hydrobromide, guaifenesin
    0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, Guaifenesin
    0113-7419basic care mucus dmdextromethorphan hydrobromide, guaifenesin
    0536-1313Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7134Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7135Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0031-8715Childrens Robitussin Cough and Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0363-0419CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-0419Good Sense Childrens Mucus Relief CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin
    0113-0359good sense tussin dmDextromethorphan Hydrobromide, Guaifenesin
    0113-1725good sense tussin dmdextromethorphan hydrobromide, guaifenesin
    0363-0505Mucus Relief DMdextromethorphan hydrobromide, guaifenesin
    0363-6812mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0904-7223robafen dmdextromethorphan hydrobromide, guaifenesin
    0031-8739ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMdextromethorphan hydrobromide, guaifenesin
    0031-8759Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0536-1348rugby cough syrupdextromethorphan hydrobromide, guaifenesin
    0372-0050Scot-Tussin Senior SF DMEXPDextromethorphan Hydrobromide, Guaifenesin
    0067-8118TriaminicDextromethorphan Hydrobromide, Guaifenesin
    0363-1144tussin dm maxDextromethorphan Hydrobromide, Guaifenesin
    0904-5180Tussin Sugar Free CoughDextromethorphan Hydrobromide, GUAIFENESIN
    11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0363-0359Wal TussinDextromethorphan Hydrobromide, Guaifenesin
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