NDC 0485-0171

ED A-HIST DM

Dextromethorphan Hydrobromide, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride

ED A-HIST DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Dextromethorphan Hydrobromide; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

Product ID0485-0171_1a30fe48-2898-4051-9341-93170a267371
NDC0485-0171
Product TypeHuman Otc Drug
Proprietary NameED A-HIST DM
Generic NameDextromethorphan Hydrobromide, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-09-11
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameEDWARDS PHARMACEUTICALS, INC.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0485-0171-16

473 mL in 1 BOTTLE, PLASTIC (0485-0171-16)
Marketing Start Date2012-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0485-0171-16 [00485017116]

ED A-HIST DM LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-09-11
Inactivation Date2020-01-31
Reactivation Date2020-04-08

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

OpenFDA Data

SPL SET ID:e0e2b117-62bc-4132-9f7c-fe2a912052b1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1086443
  • UPC Code
  • 0304850171164
  • NDC Crossover Matching brand name "ED A-HIST DM" or generic name "Dextromethorphan Hydrobromide, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0485-0171ED A-HIST DMDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE
    53809-240DOMETUSS-NRDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE

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