NDC 58602-501

Dye-Free Childrens ALLERGY

Diphenhydramine Hydrochloride

Dye-Free Childrens ALLERGY is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID58602-501_65298db6-d550-45da-a579-248966f7540f
NDC58602-501
Product TypeHuman Otc Drug
Proprietary NameDye-Free Childrens ALLERGY
Generic NameDiphenhydramine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-09-01
Marketing End Date2021-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAurohealth LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN

Packaging

NDC 58602-501-24

1 BOTTLE in 1 CARTON (58602-501-24) > 118 mL in 1 BOTTLE
Marketing Start Date2018-09-01
Marketing End Date2021-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-501-24 [58602050124]

Dye-Free Childrens ALLERGY SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:bb5f9226-cf5b-491d-a329-030f70d1218f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906

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

    NDCBrand NameGeneric Name
    58602-501Dye-Free Childrens ALLERGYDye-Free Childrens 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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