NDC 36800-200

Topcare ZZZ Sleep

Diphenhydramine Hcl

Topcare ZZZ Sleep is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID36800-200_7b66d727-ec8d-4f9f-9ef3-8536017dca90
NDC36800-200
Product TypeHuman Otc Drug
Proprietary NameTopcare ZZZ Sleep
Generic NameDiphenhydramine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-08-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameTopco Associates LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-200-30

177 mL in 1 BOTTLE (36800-200-30)
Marketing Start Date2013-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-200-50 [36800020050]

Topcare ZZZ Sleep SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-20

NDC 36800-200-30 [36800020030]

Topcare ZZZ Sleep SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-23

NDC 36800-200-34 [36800020034]

Topcare ZZZ Sleep SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-09-19

NDC 36800-200-40 [36800020040]

Topcare ZZZ Sleep SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-20

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:27225d04-6deb-436b-89ea-9842c487292e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248354
  • 1437306

    • NDC Crossover Matching brand name "Topcare ZZZ Sleep" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    36800-507Topcare ZZZ SleepTopcare ZZZ Sleep
    36800-200Topcare ZZZ SleepTopcare ZZZ Sleep
    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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