NDC 51013-104

Nighttime Sleep-Aid

Diphenhydramine Hydrochloride

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 ID51013-104_5e161f46-53d0-49e8-abac-8d1b6326ece0
NDC51013-104
Product TypeHuman Otc Drug
Proprietary NameNighttime Sleep-Aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2015-05-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePuraCap Pharmaceutical LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51013-104-02

1 BLISTER PACK in 1 CARTON (51013-104-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2015-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-104-02 [51013010402]

Nighttime Sleep-Aid CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-26

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:e85aea25-56fe-43b6-a229-9720835d639a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049909

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

    NDCBrand NameGeneric Name
    21130-004Nighttime Sleep-AidNighttime Sleep-Aid
    37835-615Nighttime Sleep-aidNighttime Sleep-aid
    37808-986Nighttime Sleep-AidNighttime Sleep-Aid
    51013-104Nighttime Sleep-AidNighttime Sleep-Aid
    53942-522Nighttime Sleep-AidNighttime Sleep-Aid
    57896-785Nighttime Sleep-aidNighttime Sleep-aid
    58602-520NIGHTTIME SLEEP-AIDNIGHTTIME SLEEP-AID
    66715-6843Nighttime Sleep-AidNighttime 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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