NDC 58809-750

Childrens PediaClear Cough

Diphenhydramine Hydrochloride

Childrens PediaClear Cough is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Diphenhydramine Hydrochloride.

Product ID58809-750_19013211-2381-48b9-b9d1-c3eb88aae307
NDC58809-750
Product TypeHuman Otc Drug
Proprietary NameChildrens PediaClear Cough
Generic NameDiphenhydramine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2019-06-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength6 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58809-750-50

50 mL in 1 BOTTLE, DROPPER (58809-750-50)
Marketing Start Date2019-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-750-50 [58809075050]

Childrens PediaClear Cough LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-06-25

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg/mL

OpenFDA Data

SPL SET ID:158246bb-2c7e-41a1-8798-fa21da20f93b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1789740
  • NDC Crossover Matching brand name "Childrens PediaClear Cough" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    58809-750Childrens PediaClear CoughChildrens PediaClear Cough
    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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