NDC 0280-1200

Aleve PM

Diphenhydramine Hydrochloride And Naproxen Sodium

Aleve PM is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Diphenhydramine Hydrochloride; Naproxen Sodium.

Product ID0280-1200_55c4de2b-84b4-1497-e054-00144ff88e88
NDC0280-1200
Product TypeHuman Otc Drug
Proprietary NameAleve PM
Generic NameDiphenhydramine Hydrochloride And Naproxen Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-09-09
Marketing CategoryNDA / NDA
Application NumberNDA205352
Labeler NameBayer HealthCare LLC.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active Ingredient Strength25 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0280-1200-02

2 TABLET, FILM COATED in 1 POUCH (0280-1200-02)
Marketing Start Date2014-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-1200-40 [00280120040]

Aleve PM TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-09

NDC 0280-1200-02 [00280120002]

Aleve PM TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-09

NDC 0280-1200-20 [00280120020]

Aleve PM TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-09

NDC 0280-1200-80 [00280120080]

Aleve PM TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-09

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:82891458-ab0d-459a-8602-dcebd22c3010
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1550963
  • 1550957
    • UPC Code
  • 0325866553065
    • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.