NDC 63868-393

Unisom SleepMelts Nighttime Sleep-Aid

Diphenhydramine Hydrochloride

Unisom SleepMelts Nighttime Sleep-Aid is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Quality Choice (chain Drug Marketing Association). The primary component is Diphenhydramine Hydrochloride.

Product ID63868-393_92daba0c-70c6-40a1-bad4-38106f8fd162
NDC63868-393
Product TypeHuman Otc Drug
Proprietary NameUnisom SleepMelts Nighttime Sleep-Aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2019-01-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63868-393-24

24 TABLET, CHEWABLE in 1 BLISTER PACK (63868-393-24)
Marketing Start Date2019-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63868-393-24 [63868039324]

Unisom SleepMelts Nighttime Sleep-Aid TABLET, CHEWABLE
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-07

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:f50cc038-0973-4c4b-84a7-1c68f41c2410
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1093098
  • 1093102

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

    NDCBrand NameGeneric Name
    41167-0014Unisom SleepMelts Nighttime Sleep-AidUnisom SleepMelts Nighttime Sleep-Aid
    63868-393Unisom SleepMelts Nighttime Sleep-AidUnisom SleepMelts 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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