NDC 55315-003

Nighttime Sleep Aid

Diphenhydramine Hydrochloride

Nighttime Sleep Aid is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID55315-003_469b51ca-4778-4366-8e00-6805fcb1469b
NDC55315-003
Product TypeHuman Otc Drug
Proprietary NameNighttime Sleep Aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-10-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler Namefred's, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55315-003-12

177 mL in 1 BOTTLE, PLASTIC (55315-003-12)
Marketing Start Date2013-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-003-12 [55315000312]

Nighttime Sleep Aid LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-10-23
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:5089fd55-d51b-4bc9-aa05-cbc175c40e04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248354

    • NDC Crossover Matching brand name "Nighttime Sleep Aid" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0236Nighttime Sleep AidDiphenhydramine HCl
    0363-0687Nighttime Sleep AidDiphenhydramine HCl
    68016-190Nighttime Sleep AidNighttime Sleep Aid
    68016-187Nighttime Sleep AidNighttime Sleep Aid
    68210-2020NIGHTTIME SLEEP AIDNIGHTTIME SLEEP AID
    68210-2010NIGHTTIME SLEEP AIDNIGHTTIME SLEEP AID
    69517-110Nighttime Sleep AidNighttime Sleep Aid
    69842-439nighttime sleep aidnighttime sleep aid
    70005-014Nighttime Sleep AidNighttime Sleep Aid
    70253-225Nighttime Sleep AidNighttime Sleep Aid
    70677-0024nighttime sleep aidnighttime sleep aid
    11673-367Nighttime Sleep AidNighttime Sleep Aid
    21130-386Nighttime Sleep AidNighttime Sleep Aid
    21130-225Nighttime Sleep AidNighttime Sleep Aid
    30142-401Nighttime Sleep AidNighttime Sleep Aid
    30142-431nighttime sleep aidnighttime sleep aid
    30142-158nighttime sleep aidnighttime sleep aid
    36800-413Nighttime Sleep AidNighttime Sleep Aid
    33992-0404Nighttime Sleep AidNighttime Sleep Aid
    37808-025Nighttime Sleep AidNighttime Sleep Aid
    37808-104Nighttime Sleep AidNighttime Sleep Aid
    37808-431nighttime sleep aidnighttime sleep aid
    37808-186Nighttime Sleep AidNighttime Sleep Aid
    41163-367Nighttime Sleep AidNighttime Sleep Aid
    41163-230Nighttime Sleep AidNighttime Sleep Aid
    41250-107Nighttime Sleep AidNighttime Sleep Aid
    41250-044nighttime sleep aidnighttime sleep aid
    41163-401Nighttime Sleep AidNighttime Sleep Aid
    41520-034Nighttime Sleep AidNighttime Sleep Aid
    49035-401Nighttime Sleep AidNighttime Sleep Aid
    49035-863Nighttime Sleep AidNighttime Sleep Aid
    50844-200Nighttime sleep aidNighttime sleep aid
    50804-230Nighttime Sleep AidNighttime Sleep Aid
    51013-181Nighttime SLEEP AIDNighttime SLEEP AID
    51013-167Nighttime Sleep AidNighttime Sleep Aid
    51013-142Nighttime SLEEP AIDNighttime SLEEP AID
    55315-404Nighttime Sleep AidNighttime Sleep Aid
    55315-003Nighttime Sleep AidNighttime Sleep Aid
    55312-230Nighttime Sleep AidNighttime Sleep Aid
    55312-200Nighttime Sleep AidNighttime Sleep Aid
    59779-441NIGHTTIME SLEEP AIDNIGHTTIME SLEEP AID
    59779-863Nighttime Sleep AidNighttime Sleep Aid
    59779-956Nighttime Sleep AidNighttime Sleep Aid
    59779-367Nighttime Sleep AidNighttime Sleep Aid
    62011-0343nighttime sleep aidnighttime sleep aid
    63941-236Nighttime sleep aidNighttime sleep aid
    63868-611Nighttime Sleep AidNighttime Sleep Aid
    63941-230Nighttime Sleep AidNighttime Sleep Aid
    64092-350Nighttime Sleep AidNighttime Sleep Aid
    67091-114Nighttime Sleep AidNighttime Sleep Aid
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