NDC 36800-507

Topcare ZZZ Sleep

Diphenhydramine Hcl

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

Product ID36800-507_688e8fe6-b40b-46a2-9d9f-2489e04bafe1
NDC36800-507
Product TypeHuman Otc Drug
Proprietary NameTopcare ZZZ Sleep
Generic NameDiphenhydramine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2014-01-28
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameTopco Associates LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-507-53

6 BLISTER PACK in 1 CARTON (36800-507-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2014-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-507-53 [36800050753]

Topcare ZZZ Sleep CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-28

NDC 36800-507-67 [36800050767]

Topcare ZZZ Sleep CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-28

NDC 36800-507-62 [36800050762]

Topcare ZZZ Sleep CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-28

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:4304584b-df01-4a77-96e2-a2b96184da54
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1488693
  • 1049909
  • 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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