NDC 53598-004

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Bonita Pharmaceuticals Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID53598-004_d602b60d-906b-4e13-ba20-185406d5739a
NDC53598-004
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine Hydrochloride
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2013-05-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBonita Pharmaceuticals LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53598-004-01

100 TABLET, COATED in 1 BOTTLE, PLASTIC (53598-004-01)
Marketing Start Date2013-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53598-004-01 [53598000401]

Diphenhydramine Hydrochloride TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-21
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:d58efe7d-c8d9-4031-8d09-432a4df7518e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
    • UPC Code
  • 0353598004012

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

    NDCBrand NameGeneric Name
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    68016-789Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    68071-1786Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    68210-1510DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    68788-9698Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    68788-9697Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69206-995Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69367-187Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69842-304Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69842-825DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    69842-834DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    70000-0207Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70385-2007Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-0441Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-0861Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-1082Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-1680Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70692-783Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0603-3339Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    71335-0435Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    71872-7005Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0615-7656Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    76045-102Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    72485-102Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    76413-306Diphenhydramine hydrochlorideDiphenhydramine hydrochloride
    76457-002diphenhydramine hydrochloridediphenhydramine hydrochloride
    0641-0376Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0904-2056Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0904-5306Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0904-6741Diphenhydramine hydrochlorideDiphenhydramine hydrochloride
    0904-6740Diphenhydramine hydrochlorideDiphenhydramine hydrochloride
    11822-6415Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-023Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-020Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-135Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-021Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    42254-190Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    42806-649Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    42806-648Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    46122-356Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    49483-329DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    50090-0046Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-0045Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-1841Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-2764Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-3787Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50436-3594Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
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