NDC 50580-535

Childrens Benadryl DYE-FREE ALLERGY

Diphenhydramine Hydrochloride

Childrens Benadryl DYE-FREE ALLERGY is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Diphenhydramine Hydrochloride.

Product ID50580-535_45abb8ba-ca25-437a-93fd-4e609e146f0e
NDC50580-535
Product TypeHuman Otc Drug
Proprietary NameChildrens Benadryl DYE-FREE ALLERGY
Generic NameDiphenhydramine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2008-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-535-01

1 BOTTLE in 1 CARTON (50580-535-01) > 118 mL in 1 BOTTLE
Marketing Start Date2015-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-535-01 [50580053501]

Childrens Benadryl DYE-FREE ALLERGY SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-12-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:10d478ff-ddc6-45da-87ff-cfe1b2b07a8e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • 1049908
    • UPC Code
  • 0350580535042

    • NDC Crossover Matching brand name "Childrens Benadryl DYE-FREE ALLERGY" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-535Childrens Benadryl DYE-FREE ALLERGYChildrens Benadryl DYE-FREE ALLERGY
    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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