NDC 57344-090

Diphenhydramine

Diphenhydramine Hydrochloride

Diphenhydramine is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Aaa Pharmaceutical, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID57344-090_7e5c78cc-d3af-1581-e053-2991aa0a92b0
NDC57344-090
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-12-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAAA Pharmaceutical, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57344-090-02

4 BLISTER PACK in 1 CARTON (57344-090-02) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2012-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-090-02 [57344009002]

Diphenhydramine TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-04-13

NDC 57344-090-03 [57344009003]

Diphenhydramine TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-27

NDC 57344-090-01 [57344009001]

Diphenhydramine TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-22
Marketing End Date2019-10-12

NDC 57344-090-05 [57344009005]

Diphenhydramine TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-22
Marketing End Date2019-10-12

NDC 57344-090-06 [57344009006]

Diphenhydramine TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-22
Marketing End Date2019-10-12

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:76724432-ff3c-404f-ba1f-5af68e3ab8c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630

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

    NDCBrand NameGeneric Name
    68196-929diphenhydraminediphenhydramine
    76413-333DiphenhydramineDiphenhydramine
    21695-500DiphenhydramineDiphenhydramine
    21695-304DiphenhydramineDiphenhydramine
    42571-169DIPHENHYDRAMINEDIPHENHYDRAMINE
    51824-048DiphenhydramineDiphenhydramine
    52959-053DiphenhydramineDiphenhydramine
    57344-090DiphenhydramineDiphenhydramine
    57344-113DiphenhydramineDiphenhydramine
    58599-003DIPHENHYDRAMINEDIPHENHYDRAMINE
    58599-004DIPHENHYDRAMINEDIPHENHYDRAMINE
    63323-664DiphenhydramineDiphenhydramine
    42571-337DIPHENHYDRAMINEDIPHENHYDRAMINE
    61010-4409DiphenhydramineDiphenhydramine
    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
    0031-9304Robitussin Direct Runny Nosediphenhydramine
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.