NDC 69367-197

Dexbrompheniramine Maleate and Phenylephrine Hydrochloride

Dexbrompheniramine Maleate And Phenylephrine Hydrochloride

Dexbrompheniramine Maleate and Phenylephrine Hydrochloride is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Westminster Pharmaceuticals. The primary component is Dexbrompheniramine Maleate; Phenylephrine Hydrochloride.

Product ID69367-197_656e7c52-011d-4e53-b079-11ddb04ebdb4
NDC69367-197
Product TypeHuman Otc Drug
Proprietary NameDexbrompheniramine Maleate and Phenylephrine Hydrochloride
Generic NameDexbrompheniramine Maleate And Phenylephrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWestminster Pharmaceuticals
Substance NameDEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69367-197-60

60 TABLET in 1 BOTTLE, PLASTIC (69367-197-60)
Marketing Start Date2018-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69367-197-60 [69367019760]

Dexbrompheniramine Maleate and Phenylephrine Hydrochloride TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-10-25

Drug Details

Active Ingredients

IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/1

OpenFDA Data

SPL SET ID:c174debf-654d-4c07-b697-778f5f411c3d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 968670

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