NDC 0536-3597

Diphenhist

Diphenhydramine Hcl

Diphenhist is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID0536-3597_f95ca994-1117-4c92-adf1-3f6825d7bf5f
NDC0536-3597
Product TypeHuman Otc Drug
Proprietary NameDiphenhist
Generic NameDiphenhydramine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2006-09-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRugby Laboratories Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0536-3597-01

100 TABLET in 1 BOTTLE (0536-3597-01)
Marketing Start Date2006-09-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-3597-01 [00536359701]

Diphenhist TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-09-26
Marketing End Date2018-07-29

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:9ca7184d-720e-4363-b5b7-34ffd61d4c6a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
  • 1092446
  • UPC Code
  • 0305363597014
  • NDC Crossover Matching brand name "Diphenhist" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    0536-0770DiphenhistDiphenhist
    0536-1010DiphenhistDiphenhist
    0536-3597DiphenhistDiphenhist
    0536-3594DiphenhistDiphenhist
    70518-1836DiphenhistDiphenhist
    0113-7379basic care childrens allergy reliefDiphenhydramine HCl
    0113-7186basic care nighttime sleep aidDiphenhydramine HCl
    0113-7506basic care nighttime sleep aiddiphenhydramine hcl
    0363-0481Childrens Allergy Dye-Free Wal DrylDiphenhydramine HCl
    0113-0379good sense allergyDiphenhydramine HCl
    0113-0052good sense sleep timeDiphenhydramine HCl
    0113-0186Good Sense Sleep TimeDiphenhydramine HCl
    0363-0353Itch Relief GelDiphenhydramine HCl
    0363-0236Nighttime Sleep AidDiphenhydramine HCl
    0363-0367Sleep AidDiphenhydramine HCl
    0363-0189Sleep IIDiphenhydramine HCl
    0363-0190Wal-DrylDiphenhydramine HCl
    0363-0418Wal-DrylDiphenhydramine HCl
    0363-0329WAL-DRYL ALLERGYDiphenhydramine HCl
    0363-0020Wal-Sleep ZDiphenhydramine HCl

    Trademark Results [Diphenhist]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIPHENHIST
    DIPHENHIST
    73605132 1721331 Live/Registered
    RUGBY LABORATORIES, INC.
    1986-06-19

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