NDC 51013-167

Nighttime Sleep Aid

Diphenhydramine Hydrochloride

Nighttime Sleep Aid is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID51013-167_0560a431-6887-4826-bcea-9d627e3a9156
NDC51013-167
Product TypeHuman Otc Drug
Proprietary NameNighttime Sleep Aid
Generic NameDiphenhydramine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-07-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NamePuraCap Pharmaceutical LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51013-167-13

4 BLISTER PACK in 1 CARTON (51013-167-13) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-167-13 [51013016713]

Nighttime Sleep Aid CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-26

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:dac0ec69-4c8f-4455-a26a-37dbe19ffd00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049909
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.