NDC 50580-843

Simply Sleep

Diphenhydramine Hydrochloride

Simply Sleep is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Diphenhydramine Hydrochloride.

Product ID50580-843_2a5a0d0f-b1e7-4180-ad5c-4ceb3f07feb7
NDC50580-843
Product TypeHuman Otc Drug
Proprietary NameSimply Sleep
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2004-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-843-12

1 BOTTLE in 1 CARTON (50580-843-12) > 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2013-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-843-12 [50580084312]

Simply Sleep TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2013-04-10

NDC 50580-843-11 [50580084311]

Simply Sleep TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-09-26

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:37c606b0-04d5-49f0-886a-3ee2c9b0e9cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092466
  • 1049630
    • UPC Code
  • 0300450843241

    • NDC Crossover Matching brand name "Simply Sleep" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-843Simply SleepSimply Sleep
    0363-7100Adult Allergy ReliefDiphenhydramine Hydrochloride
    0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
    0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
    0363-0710childrens Allergy Dye Free Wal DrylDiphenhydramine hydrochloride
    0363-0004Childrens WAL-DRYLDiphenhydramine Hydrochloride
    0121-0865Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-1730Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    0363-0293Dye Free Wal Dryl AllergyDiphenhydramine Hydrochloride
    0363-0753Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDE
    0113-0462Good Sense Allergy Reliefdiphenhydramine hydrochloride
    0113-0479good sense allergy reliefDiphenhydramine Hydrochloride
    0113-0431good sense nighttime sleep aidDiphenhydramine Hydrochloride
    0113-1909good sense sleep aiddiphenhydramine hydrochloride
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride

    Trademark Results [Simply Sleep]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SIMPLY SLEEP
    SIMPLY SLEEP
    75481909 2396266 Live/Registered
    JOHNSON & JOHNSON
    1998-05-08
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