NDC 0031-8739

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM

Dextromethorphan Hydrobromide, Guaifenesin

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Wyeth Consumer Healthcare Llc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID0031-8739_54503ab0-863a-42ae-9fab-cf7e04a32af3
NDC0031-8739
Product TypeHuman Otc Drug
Proprietary NameROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
Generic NameDextromethorphan Hydrobromide, Guaifenesin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2016-06-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWyeth Consumer Healthcare LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength20 mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0031-8739-12

1 BOTTLE in 1 CARTON (0031-8739-12) > 118 mL in 1 BOTTLE
Marketing Start Date2016-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8739-12 [00031873912]

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-06-01

NDC 0031-8739-18 [00031873918]

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-06-01

NDC 0031-8739-42 [00031873942]

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-06-01

NDC 0031-8739-16 [00031873916]

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-06-06
Marketing End Date2011-06-08

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL

OpenFDA Data

SPL SET ID:f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020138
  • 1545786
    • UPC Code
  • 0000000000000

    • NDC Crossover Matching brand name "ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM" or generic name "Dextromethorphan Hydrobromide, Guaifenesin"

    NDCBrand NameGeneric Name
    0031-8719Robitussin Maximum Strength Cough Plus Chest Congestion DMdextromethorphan hydrobromide and guaifenesin
    0031-8739ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMdextromethorphan 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
    0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan 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
    0363-0359Wal TussinDextromethorphan Hydrobromide, Guaifenesin
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.