NDC 36800-116

Nighttime Sleep Aid

Diphenhydramine Hcl

Nighttime Sleep Aid is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Top Care (topco Associates Llc). The primary component is Diphenhydramine Hydrochloride.

Product ID36800-116_584e7867-a7ae-45a9-b20f-836ce109a587
NDC36800-116
Product TypeHuman Otc Drug
Proprietary NameNighttime Sleep Aid
Generic NameDiphenhydramine Hcl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-01-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameTOP CARE (Topco Associates LLC)
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 36800-116-32

1 BOTTLE, PLASTIC in 1 BOX (36800-116-32) > 32 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date2020-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-116-64 [36800011664]

Nighttime Sleep Aid CAPSULE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-31

NDC 36800-116-32 [36800011632]

Nighttime Sleep Aid CAPSULE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:027d7eff-6c83-40f1-9716-231637cdbeba
Manufacturer
UNII
UPC Code
  • 0036800114173

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

    NDCBrand NameGeneric Name
    0363-0236Nighttime 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
    66715-6943Nighttime Sleep AidNighttime Sleep Aid
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.