NDC 51013-129

Night Time Sleep Aid

Diphenhydramine Hydrochloride

Night Time 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 ID51013-129_6b570567-d92f-46f8-85b2-16022e4bc502
NDC51013-129
Product TypeHuman Otc Drug
Proprietary NameNight Time Sleep Aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-05-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NamePuraCap Pharmaceutical LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51013-129-02

1 BLISTER PACK in 1 CARTON (51013-129-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-129-02 [51013012902]

Night Time Sleep Aid CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-05

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:ac1ce01c-48e2-4734-9361-ff4d45b4b658
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049909

    • NDC Crossover Matching brand name "Night Time Sleep Aid" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    42507-236Night Time Sleep AidNight Time Sleep Aid
    42507-959Night Time Sleep AidNight Time Sleep Aid
    51013-129Night Time Sleep AidNight Time Sleep Aid
    55910-114Night Time Sleep AidNight Time Sleep Aid
    63940-404Night Time Sleep AidNight Time 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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