NDC 49781-048

Leader SleepTime

Diphenhydramine Hcl

Leader SleepTime is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Diphenhydramine Hydrochloride.

Product ID49781-048_3f8ab7c6-6d47-4cd5-b9b9-092db781b3ca
NDC49781-048
Product TypeHuman Otc Drug
Proprietary NameLeader SleepTime
Generic NameDiphenhydramine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-10-11
Marketing End Date2019-04-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameCardinal Health
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL
NDC Exclude FlagN

Packaging

NDC 49781-048-06

177 mL in 1 BOTTLE (49781-048-06)
Marketing Start Date2013-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49781-048-06 [49781004806]

Leader SleepTime SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-10-11
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:b58e1d47-ca5f-4556-8cd1-3dc80b046567
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248354
    • UPC Code
  • 0096295125108

    • NDC Crossover Matching brand name "Leader SleepTime" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    49781-048Leader SleepTimeLeader SleepTime
    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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