NDC 0498-0097

North Antihistamine

Diphenhydramine

North Antihistamine is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Honeywell Safety Products Usa, Inc. The primary component is Diphenhydramine Hydrochloride.

Product ID0498-0097_ad849e9a-6e1f-481d-ad72-d5ce453d35c8
NDC0498-0097
Product TypeHuman Otc Drug
Proprietary NameNorth Antihistamine
Generic NameDiphenhydramine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-12-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHoneywell Safety Products USA, Inc
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0498-0097-20

200 PACKET in 1 BOX, UNIT-DOSE (0498-0097-20) > 2 TABLET in 1 PACKET
Marketing Start Date2011-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0498-0097-20 [00498009720]

North Antihistamine TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-12-02
Marketing End Date2019-11-19

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:8433fdab-fac2-4f29-9e0d-6c99189847a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
  • NDC Crossover Matching brand name "North Antihistamine" or generic name "Diphenhydramine"

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

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