NDC 63162-520

Balahist DM Syrup

Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide

Balahist DM Syrup is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Ballay Pharmaceuticals, Inc.. The primary component is Brompheniramine Maleate; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID63162-520_da947d56-e0f5-4f91-88bd-82990cd4a7c4
NDC63162-520
Product TypeHuman Otc Drug
Proprietary NameBalahist DM Syrup
Generic NameBrompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-01-06
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBallay Pharmaceuticals, Inc.
Substance NameBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength4 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63162-520-16

473 mL in 1 BOTTLE (63162-520-16)
Marketing Start Date2014-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63162-520-16 [63162052016]

Balahist DM Syrup LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-06
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE4 mg/5mL

OpenFDA Data

SPL SET ID:3434547a-6ef1-496f-93a2-e1c0539ebaaa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1486964

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