NDC 58605-153

BroveX PEB DM

Brompheniramine Maleate, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide

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

Product ID58605-153_6c2d7ce5-af0f-4a67-af49-ebe16e165dd4
NDC58605-153
Product TypeHuman Otc Drug
Proprietary NameBroveX PEB DM
Generic NameBrompheniramine Maleate, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2007-11-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMCR American 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 58605-153-02

20 mL in 1 BOTTLE, PLASTIC (58605-153-02)
Marketing Start Date2007-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58605-153-01 [58605015301]

BroveX PEB DM LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2007-11-30
Marketing End Date2013-10-31
Inactivation Date2019-10-29
Reactivation Date2020-05-21

NDC 58605-153-02 [58605015302]

BroveX PEB DM LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-11-30
Marketing End Date2013-10-31
Inactivation Date2019-10-29
Reactivation Date2020-05-21

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE4 mg/5mL

OpenFDA Data

SPL SET ID:f5563c71-b1bc-4800-bf55-7abf058444b6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1148155
  • UPC Code
  • 0358605153011

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