NDC 0363-0189

Sleep II Nighttime Sleep Aid

Diphenhydramine Hcl

Sleep II Nighttime Sleep Aid is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Diphenhydramine Hydrochloride.

Product ID0363-0189_25806a8d-ca50-46ea-8cb2-60d71d161aba
NDC0363-0189
Product TypeHuman Otc Drug
Proprietary NameSleep II Nighttime Sleep Aid
Generic NameDiphenhydramine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1990-04-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameWalgreen Company
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 0363-0189-08

3 BLISTER PACK in 1 CARTON (0363-0189-08) > 8 TABLET in 1 BLISTER PACK
Marketing Start Date1990-04-10
Marketing End Date2022-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0189-46 [00363018946]

Sleep II Nighttime Sleep Aid TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date1990-04-10

NDC 0363-0189-08 [00363018908]

Sleep II Nighttime Sleep Aid TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1990-04-10

NDC 0363-0189-21 [00363018921]

Sleep II Nighttime Sleep Aid TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1990-04-10
Marketing End Date2018-07-08

NDC 0363-0189-23 [00363018923]

Sleep II Nighttime Sleep Aid TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1990-04-10

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:ed864c84-a430-4ca8-87e8-04f1c1df538b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
    • UPC Code
  • 0311917148939

    • NDC Crossover Matching brand name "Sleep II Nighttime Sleep Aid" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    0113-7379basic care childrens allergy reliefDiphenhydramine HCl
    0113-7186basic care nighttime sleep aidDiphenhydramine HCl
    0113-7506basic care nighttime sleep aiddiphenhydramine hcl
    0363-0481Childrens Allergy Dye-Free Wal DrylDiphenhydramine HCl
    0113-0379good sense allergyDiphenhydramine HCl
    0113-0052good sense sleep timeDiphenhydramine HCl
    0113-0186Good Sense Sleep TimeDiphenhydramine HCl
    0363-0353Itch Relief GelDiphenhydramine HCl
    0363-0236Nighttime Sleep AidDiphenhydramine HCl
    0363-0367Sleep AidDiphenhydramine HCl
    0363-0189Sleep IIDiphenhydramine HCl
    0363-0190Wal-DrylDiphenhydramine HCl
    0363-0418Wal-DrylDiphenhydramine HCl
    0363-0329WAL-DRYL ALLERGYDiphenhydramine HCl
    0363-0020Wal-Sleep ZDiphenhydramine HCl
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