NDC 21695-500

Diphenhydramine

Diphenhydramine

Diphenhydramine is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Diphenhydramine Hydrochloride.

Product ID21695-500_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41
NDC21695-500
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine
Generic NameDiphenhydramine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameRebel Distributors Corp
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-500-15

15 CAPSULE in 1 BOTTLE (21695-500-15)
Marketing Start Date2007-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-500-15 [21695050015]

Diphenhydramine CAPSULE
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2007-01-01
Inactivation Date2019-09-24

NDC 21695-500-30 [21695050030]

Diphenhydramine CAPSULE
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2007-01-01
Inactivation Date2019-09-24

NDC 21695-500-20 [21695050020]

Diphenhydramine CAPSULE
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2007-01-01
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:c46e1443-dffe-47a9-bc9a-acbe3a8b0b41
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049909

    • NDC Crossover Matching brand name "Diphenhydramine" or generic name "Diphenhydramine"

    NDCBrand NameGeneric Name
    21695-304DiphenhydramineDiphenhydramine
    21695-500DiphenhydramineDiphenhydramine
    40002-004DiphenhydramineDiphenhydramine HCl, Zinc Acetate
    42571-169DIPHENHYDRAMINEDiphenhydramine Hydrochloride
    42571-337DIPHENHYDRAMINEDiphenhydramine Hydrochloride
    51824-048DiphenhydramineDiphenhydramine Hydrochloride
    52959-053DiphenhydramineDiphenhydramine Hydrochloride
    57344-090DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDE
    57344-113DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDE
    58599-003DIPHENHYDRAMINEDIPHENHYDRAMINE HYDROCHLORIDE
    58599-004DIPHENHYDRAMINEDIPHENHYDRAMINE HYDROCHLORIDE
    61010-4409DiphenhydramineDiphenhydramine Hydrochloride
    63323-664DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDE
    68196-929diphenhydraminediphenhydramine HCl
    76413-333DiphenhydramineDiphenhydramine Hydrochloride
    71594-700FirstCare Childrens Allergy Diphenhydramine HCl Chewable GelsDiphenhydramine
    49260-613Help I cant SleepDiphenhydramine
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.