NDC 53807-204

Diphenhydramine Oral Liquid

Diphenhydramine Hydrochloride

Diphenhydramine Oral Liquid is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Rij Pharmaceutical Corporation. The primary component is Diphenhydramine Hydrochloride.

Product ID53807-204_e241709f-9874-407f-8de4-440c768d5b79
NDC53807-204
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine Oral Liquid
Generic NameDiphenhydramine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date1999-03-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRij Pharmaceutical Corporation
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53807-204-16

473 mL in 1 BOTTLE (53807-204-16)
Marketing Start Date1999-03-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53807-204-08 [53807020408]

Diphenhydramine Oral Liquid LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1999-03-16
Inactivation Date2020-01-31

NDC 53807-204-04 [53807020404]

Diphenhydramine Oral Liquid LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1999-03-16
Inactivation Date2020-01-31

NDC 53807-204-16 [53807020416]

Diphenhydramine Oral Liquid LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1999-03-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:af5b9c99-03b8-4cf3-80d5-e484b36b6873
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • NDC Crossover Matching brand name "Diphenhydramine Oral Liquid" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    53807-204Diphenhydramine Oral LiquidDiphenhydramine Oral Liquid
    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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