NDC 76281-522

Nighttime Sleep-Aid Non-Habit Forming

Diphenhydramine Hci

Nighttime Sleep-Aid Non-Habit Forming is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Aptapharma Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID76281-522_3596b89d-6613-4509-91eb-680462bdaeef
NDC76281-522
Product TypeHuman Otc Drug
Proprietary NameNighttime Sleep-Aid Non-Habit Forming
Generic NameDiphenhydramine Hci
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameAptaPharma Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76281-522-24

118 mL in 1 BOTTLE (76281-522-24)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76281-522-28 [76281052228]

Nighttime Sleep-Aid Non-Habit Forming LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:ed0ba7aa-e794-43da-b576-6b9945bf7477
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248354
  • NDC Crossover Matching brand name "Nighttime Sleep-Aid Non-Habit Forming" or generic name "Diphenhydramine Hci"

    NDCBrand NameGeneric Name
    49035-164Allergy ReliefDiphenhydramine HCI
    51662-1218DIPHENHYDRAMINE HCIDIPHENHYDRAMINE HCI
    76281-522Nighttime Sleep-AidDiphenhydramine HCI

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