NDC 58657-528

M-Dryl

Diphenhydramine Hydrochloride

M-Dryl is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Method Pharmaceuticals, Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID58657-528_3bbf9ece-5044-48b6-bee4-4731ab16a66e
NDC58657-528
Product TypeHuman Otc Drug
Proprietary NameM-Dryl
Generic NameDiphenhydramine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMethod Pharmaceuticals, LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58657-528-04

120 mL in 1 BOTTLE (58657-528-04)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58657-528-04 [58657052804]

M-Dryl LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-08-01

NDC 58657-528-16 [58657052816]

M-Dryl LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:5a60c923-8bb7-427f-9636-08ed5474f71b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906

    • NDC Crossover Matching brand name "M-Dryl" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    58657-528M-DrylM-Dryl
    63629-1159M-DrylM-Dryl
    63629-1160M-DrylM-Dryl
    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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