NDC 69168-261

Acetaminophen Phenylephrine HCl

Acetaminophen 500mg Phenylephrine Hcl 5mg

Acetaminophen Phenylephrine HCl is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Allegiant Health. The primary component is Acetaminophen; Phenylephrine Hydrochloride.

Product ID69168-261_a1a8c1b0-1c3d-4d32-b505-e92a19623f65
NDC69168-261
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen Phenylephrine HCl
Generic NameAcetaminophen 500mg Phenylephrine Hcl 5mg
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-12-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameAllegiant Health
Substance NameACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69168-261-99

23437 TABLET in 1 CARTON (69168-261-99)
Marketing Start Date2014-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69168-261-99 [69168026199]

Acetaminophen Phenylephrine HCl TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-12-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:a1a8c1b0-1c3d-4d32-b505-e92a19623f65
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1101534

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