NDC 51013-420

MAXIMUM STRENGTH Nighttime Sleep Aid

Diphenhydramine Hydrochloride

MAXIMUM STRENGTH Nighttime Sleep Aid is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID51013-420_37687272-1bf6-41ba-9c9f-c57d96e54075
NDC51013-420
Product TypeHuman Otc Drug
Proprietary NameMAXIMUM STRENGTH Nighttime Sleep Aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-09-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NamePuraCap Pharmaceutical LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51013-420-38

200 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-420-38)
Marketing Start Date2017-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-420-38 [51013042038]

MAXIMUM STRENGTH Nighttime Sleep Aid CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-25

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:d1ccefba-f220-4983-b3f5-ca844f2b1bca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020477

    • NDC Crossover Matching brand name "MAXIMUM STRENGTH Nighttime Sleep Aid" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    69842-392MAXIMUM STRENGTH Nighttime Sleep AidMAXIMUM STRENGTH Nighttime Sleep Aid
    51013-179MAXIMUM STRENGTH Nighttime Sleep AidMAXIMUM STRENGTH Nighttime Sleep Aid
    51013-420MAXIMUM STRENGTH Nighttime Sleep AidMAXIMUM STRENGTH Nighttime Sleep Aid
    69842-624MAXIMUM STRENGTH Nighttime Sleep AidMAXIMUM STRENGTH Nighttime Sleep Aid
    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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