NDC 0031-8753

Robitussin 12 Hour Cough Relief

Dextromethorphan Polistirex

Robitussin 12 Hour Cough Relief is a Oral Suspension, Extended Release in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Dextromethorphan Hydrobromide.

Product ID0031-8753_16e55ae2-3c05-43e7-96f5-ae0faa7d08d6
NDC0031-8753
Product TypeHuman Otc Drug
Proprietary NameRobitussin 12 Hour Cough Relief
Generic NameDextromethorphan Polistirex
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA091135
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0031-8753-03

1 BOTTLE in 1 CARTON (0031-8753-03) > 89 mL in 1 BOTTLE
Marketing Start Date2015-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8753-03 [00031875303]

Robitussin 12 Hour Cough Relief SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091135
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-07-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

OpenFDA Data

SPL SET ID:5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659520
  • 1373045
  • NDC Crossover Matching brand name "Robitussin 12 Hour Cough Relief" or generic name "Dextromethorphan Polistirex"

    NDCBrand NameGeneric Name
    0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0113-7384basic care cough DMdextromethorphan polistirex
    0363-0899childrens cough dmDextromethorphan polistirex
    0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0363-0384Cough DMdextromethorphan polistirex
    0363-0494Cough DMdextromethorphan polistirex
    0363-0958Cough DMdextromethorphan polistirex
    0904-6312cough dmdextromethorphan polistirex
    11822-0384Cough DMdextromethorphan polistirex
    11822-0494Cough DMdextromethorphan polistirex
    0113-0384good sense cough dmdextromethorphan polistirex
    0113-0958Good Sense Cough DMdextromethorphan polistirex
    11673-114up and up 12 hour cough reliefdextromethorphan polistirex

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