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 ID: 49260-613_0e723c3c-c6bd-46b2-9302-1faec8278095
• NDC: 49260-613
• Product Type: Human Otc Drug
• Proprietary Name: Help I cant Sleep
• Generic Name: Diphenhydramine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part336
• Labeler Name: Help Remedies, Inc.
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49260-613-16

16 TABLET in 1 BLISTER PACK (49260-613-16)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49260-613-16 [49260061316]

Help I cant Sleep TABLET

• Marketing Category: OTC monograph final
• Application Number: part336
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2019-10-29

NDC 49260-613-50 [49260061350]

Help I cant Sleep TABLET

• Marketing Category: OTC monograph final
• Application Number: part336
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: a182d099-1b11-4d88-a246-f2e2ae75f340
• Manufacturer:
  • Help Remedies, Inc.
• UNII:
  • TC2D6JAD40
• RxNorm Concept Unique ID - RxCUI:
  • 1049630

NDC Crossover Matching brand name "Help I cant Sleep" or generic name "Diphenhydramine"

NDC	Brand Name	Generic Name
49260-613	Help I cant Sleep	Diphenhydramine
21695-304	Diphenhydramine	Diphenhydramine
21695-500	Diphenhydramine	Diphenhydramine
71594-700	FirstCare Childrens Allergy Diphenhydramine HCl Chewable Gels	Diphenhydramine
50332-0132	HISTAPRIN	DIPHENHYDRAMINE
58805-006	Nightime Sleep Aid	Diphenhydramine
76168-065	Nightime Sleep Aid	Diphenhydramine
0498-0097	North Antihistamine	DIPHENHYDRAMINE
70648-133	OLP ANTI-ITCH ALLERGY RELIEF	diphenhydramine
0031-9304	Robitussin Direct Runny Nose	diphenhydramine
76168-066	ZzzSleep	Diphenhydramine