NDC 62207-912

Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride

Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride

Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Granules India Limited. The primary component is Phenylephrine Hydrochloride; Acetaminophen; Dextromethorphan Hydrobromide.

Product ID62207-912_50beec79-a713-0d98-e054-00144ff88e88
NDC62207-912
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride
Generic NameAcetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-07-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGranules India Limited
Substance NamePHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength5 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 62207-912-69

12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (62207-912-69)
Marketing Start Date2017-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62207-912-69 [62207091269]

Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:50beec79-a712-0d98-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1086997

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