NDC 68071-3193

Diphenhydramine Hydrochloride Antihistamine

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride Antihistamine is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Nucare Pharmaceuticals, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID68071-3193_6e247d59-4565-5f51-e053-2a91aa0a0922
NDC68071-3193
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine Hydrochloride Antihistamine
Generic NameDiphenhydramine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2003-08-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameNuCare Pharmaceuticals, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-3193-4

118 mL in 1 BOTTLE (68071-3193-4)
Marketing Start Date2017-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3193-4 [68071319304]

Diphenhydramine Hydrochloride Antihistamine SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-12

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:51c8a1cf-f4d3-0e4d-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906

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

    NDCBrand NameGeneric Name
    68071-3193Diphenhydramine Hydrochloride AntihistamineDiphenhydramine Hydrochloride Antihistamine
    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
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