NDC 58602-022

Aurodryl childrens Allergy

Diphenhydramine Hydrochloride

Aurodryl 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 ID58602-022_305c12ff-a8df-44b6-935e-50c64fca21fe
NDC58602-022
Product TypeHuman Otc Drug
Proprietary NameAurodryl childrens Allergy
Generic NameDiphenhydramine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-05-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAurohealth LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58602-022-20

1 BOTTLE in 1 CARTON (58602-022-20) > 236 mL in 1 BOTTLE
Marketing Start Date2015-05-13
Marketing End Date2022-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-022-20 [58602002220]

Aurodryl childrens Allergy SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-13

NDC 58602-022-24 [58602002224]

Aurodryl childrens Allergy SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-05-13

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:305c12ff-a8df-44b6-935e-50c64fca21fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • NDC Crossover Matching brand name "Aurodryl childrens Allergy" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    58602-022Aurodryl childrens AllergyAurodryl childrens Allergy
    58602-023Aurodryl Childrens AllergyAurodryl 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.