NDC 0031-8692

Childrens Robitussin Nighttime Cough Long-Acting DM

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide

Childrens Robitussin Nighttime Cough Long-Acting DM is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Chlorpheniramine Maleate; Dextromethorphan Hydrobromide.

Product ID0031-8692_6417ef02-4da5-45fc-9746-9f4651217c27
NDC0031-8692
Product TypeHuman Otc Drug
Proprietary NameChildrens Robitussin Nighttime Cough Long-Acting DM
Generic NameChlorpheniramine Maleate, Dextromethorphan Hydrobromide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength2 mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0031-8692-13

1 BOTTLE in 1 CARTON (0031-8692-13) > 118 mL in 1 BOTTLE
Marketing Start Date2014-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8692-13 [00031869213]

Childrens Robitussin Nighttime Cough Long-Acting DM SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-07-01

Drug Details

Active Ingredients

IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/10mL

OpenFDA Data

SPL SET ID:8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1547605
  • 1111440
  • NDC Crossover Matching brand name "Childrens Robitussin Nighttime Cough Long-Acting DM" or generic name "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    0031-8692Childrens Robitussin Nighttime Cough Long-Acting DMchlorpheniramine maleate, dextromethorphan hydrobromide
    24286-1551Bactimicina Childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

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