NDC 76413-333

Diphenhydramine

Diphenhydramine Hydrochloride

Diphenhydramine is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Central Texas Community Health Centers. The primary component is Diphenhydramine Hydrochloride.

Product ID76413-333_3776b551-632c-40ee-aaac-f8a4acefb3f0
NDC76413-333
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine
Generic NameDiphenhydramine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2003-08-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCentral Texas Community Health Centers
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76413-333-01

118 mL in 1 BOTTLE (76413-333-01)
Marketing Start Date2003-08-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76413-333-01 [76413033301]

Diphenhydramine SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2003-08-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:77230b87-90fc-4ed6-b0ab-5671bb4f4eef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906

    • 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.