NDC 36800-672

Sleep Aid

Diphenhydramine Hcl

Sleep Aid is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates, Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID36800-672_40b895b7-3f6a-4c8c-9ab5-05267eef0c24
NDC36800-672
Product TypeHuman Otc Drug
Proprietary NameSleep Aid
Generic NameDiphenhydramine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-07-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameTopco Associates, LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 36800-672-06

200 TABLET, FILM COATED in 1 BOTTLE (36800-672-06)
Marketing Start Date2015-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-672-06 [36800067206]

Sleep Aid TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-24

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:57a81e24-ef0d-4143-b266-71e2d4be7617
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
  • UPC Code
  • 0036800495821