NDC 70000-0174

LEADER Nighttime Sleep-Aid

Diphenhydramine Hydrochloride

LEADER Nighttime Sleep-Aid is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Diphenhydramine Hydrochloride.

Product ID70000-0174_02ae2015-b680-4b3f-8998-dcd4b4b7c708
NDC70000-0174
Product TypeHuman Otc Drug
Proprietary NameLEADER Nighttime Sleep-Aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2017-01-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameCARDINAL HEALTH
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0174-2

177 mL in 1 BOTTLE, PLASTIC (70000-0174-2)
Marketing Start Date2017-03-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0174-1 [70000017401]

LEADER Nighttime Sleep-Aid LIQUID
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-17

NDC 70000-0174-2 [70000017402]

LEADER Nighttime Sleep-Aid LIQUID
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-13

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:6fe34d05-84a4-4254-aea6-77b52122ea18
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248354
  • NDC Crossover Matching brand name "LEADER Nighttime Sleep-Aid" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    70000-0174LEADER Nighttime Sleep-AidLEADER Nighttime 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

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