NDC 49260-613

Help I cant Sleep

Diphenhydramine

Help I cant Sleep is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Help Remedies, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID49260-613_0e723c3c-c6bd-46b2-9302-1faec8278095
NDC49260-613
Product TypeHuman Otc Drug
Proprietary NameHelp I cant Sleep
Generic NameDiphenhydramine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart336
Labeler NameHelp Remedies, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49260-613-16

16 TABLET in 1 BLISTER PACK (49260-613-16)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49260-613-16 [49260061316]

Help I cant Sleep TABLET
Marketing CategoryOTC monograph final
Application Numberpart336
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-29

NDC 49260-613-50 [49260061350]

Help I cant Sleep TABLET
Marketing CategoryOTC monograph final
Application Numberpart336
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:a182d099-1b11-4d88-a246-f2e2ae75f340
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
  • NDC Crossover Matching brand name "Help I cant Sleep" or generic name "Diphenhydramine"

    NDCBrand NameGeneric Name
    49260-613Help I cant SleepDiphenhydramine
    21695-304DiphenhydramineDiphenhydramine
    21695-500DiphenhydramineDiphenhydramine
    71594-700FirstCare Childrens Allergy Diphenhydramine HCl Chewable GelsDiphenhydramine
    50332-0132HISTAPRINDIPHENHYDRAMINE
    58805-006Nightime Sleep AidDiphenhydramine
    76168-065Nightime Sleep AidDiphenhydramine
    0498-0097North AntihistamineDIPHENHYDRAMINE
    70648-133OLP ANTI-ITCH ALLERGY RELIEFdiphenhydramine
    0031-9304Robitussin Direct Runny Nosediphenhydramine
    76168-066ZzzSleepDiphenhydramine

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