NDC 55316-384

healthy accents cough relief

Dextromethorphan Polistirex

healthy accents cough relief is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Dextromethorphan Hydrobromide.

Product ID55316-384_16ee2e5c-f6fb-496c-995a-c32f8ce869f3
NDC55316-384
Product TypeHuman Otc Drug
Proprietary Namehealthy accents cough relief
Generic NameDextromethorphan Polistirex
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA091135
Labeler NameDZA Brands LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55316-384-21

1 BOTTLE in 1 CARTON (55316-384-21) > 89 mL in 1 BOTTLE
Marketing Start Date2012-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-384-21 [55316038421]

healthy accents cough relief SUSPENSION
Marketing CategoryANDA
Application NumberANDA091135
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

OpenFDA Data

SPL SET ID:0d47ee81-930a-419d-8522-eedce22b9fb0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373045
  • NDC Crossover Matching brand name "healthy accents cough relief" or generic name "Dextromethorphan Polistirex"

    NDCBrand NameGeneric Name
    55316-384healthy accents cough reliefhealthy accents cough relief
    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
    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
    11673-114up and up 12 hour cough reliefdextromethorphan polistirex

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