NDC 37835-615

Nighttime Sleep-aid

Diphenhydramine Hydrochloride

Nighttime Sleep-aid is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Bi-mart. The primary component is Diphenhydramine Hydrochloride.

Product ID37835-615_797f8c69-6b41-48b5-ae07-28862aaa601d
NDC37835-615
Product TypeHuman Otc Drug
Proprietary NameNighttime Sleep-aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-01-07
Marketing End Date2022-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameBi-Mart
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL
NDC Exclude FlagN

Packaging

NDC 37835-615-16

354 mL in 1 BOTTLE (37835-615-16)
Marketing Start Date2019-01-07
Marketing End Date2022-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37835-615-16 [37835061516]

Nighttime Sleep-aid SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-07

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:ffeb1ec9-3643-4e1d-be3b-d9d22766e5bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248354

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.