NDC 50580-534

Childrens Benadryl ALLERGY

Diphenhydramine Hydrochloride

Childrens Benadryl 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 ID50580-534_72f0618d-954a-4946-b6f4-f818ed5314cc
NDC50580-534
Product TypeHuman Otc Drug
Proprietary NameChildrens Benadryl 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 50580-534-04

1 BOTTLE in 1 CARTON (50580-534-04) > 118 mL in 1 BOTTLE
Marketing Start Date2008-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-534-08 [50580053408]

Childrens Benadryl ALLERGY SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2008-07-01

NDC 50580-534-16 [50580053416]

Childrens Benadryl ALLERGY SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-01-28

NDC 50580-534-04 [50580053404]

Childrens Benadryl ALLERGY SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2008-07-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:fc9181b9-c92d-493e-8d7c-4a4239c6c092
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • 1049908

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

    NDCBrand NameGeneric Name
    50580-534Childrens Benadryl ALLERGYChildrens Benadryl 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.