NDC 50580-232

Childrens Benadryl Chewables

Diphenhydramine Hydrochloride

Childrens Benadryl Chewables is a Oral Tablet, Chewable 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 ID50580-232_0799ace5-53b7-4264-93a4-35ff0c4534ae
NDC50580-232
Product TypeHuman Otc Drug
Proprietary NameChildrens Benadryl Chewables
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2016-07-11
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/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-232-01

2 BLISTER PACK in 1 CARTON (50580-232-01) > 10 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date2016-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-232-01 [50580023201]

Childrens Benadryl Chewables TABLET, CHEWABLE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2016-07-11

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:b08f71d8-a06c-41ba-8ed1-fbc41dbc1919
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049900
  • 1049901
  • UPC Code
  • 0300450553201
  • NDC Crossover Matching brand name "Childrens Benadryl Chewables" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-232Childrens Benadryl ChewablesChildrens Benadryl Chewables
    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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