NDC 68094-022

Dye Free Childrens Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

Dye Free Childrens Diphenhydramine Hydrochloride is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Precision Dose, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID68094-022_0da20c48-15a9-4d4f-808b-d4f70c8519a2
NDC68094-022
Product TypeHuman Otc Drug
Proprietary NameDye Free Childrens Diphenhydramine Hydrochloride
Generic NameDiphenhydramine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-12-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePrecision Dose, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68094-022-62

3 TRAY in 1 CASE (68094-022-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-022-59)
Marketing Start Date2018-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68094-022-59 [68094002259]

Dye Free Childrens Diphenhydramine Hydrochloride LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-12-27

NDC 68094-022-62 [68094002262]

Dye Free Childrens Diphenhydramine Hydrochloride LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-12-27

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:139f7be5-c361-492c-ba3a-573ced661857
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906

    • NDC Crossover Matching brand name "Dye Free Childrens Diphenhydramine Hydrochloride" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    68094-022Dye Free Childrens Diphenhydramine HydrochlorideDye Free Childrens Diphenhydramine Hydrochloride
    68094-024Dye Free Childrens Diphenhydramine HydrochlorideDye Free Childrens Diphenhydramine Hydrochloride
    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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