NDC 0904-6731

Acetaminophen, Diphenhydramine Hydrochloride

Acetaminophen, Diphenhydramine Hydrochloride

Acetaminophen, Diphenhydramine Hydrochloride is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Acetaminophen; Diphenhydramine Hydrochloride.

Product ID0904-6731_786dbcd5-f5c3-4491-e053-2991aa0a3437
NDC0904-6731
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen, Diphenhydramine Hydrochloride
Generic NameAcetaminophen, Diphenhydramine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-12-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameMajor Pharmaceuticals
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0904-6731-51

1 BOTTLE in 1 CARTON (0904-6731-51) > 50 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2018-12-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6731-51 [00904673151]

Acetaminophen, Diphenhydramine Hydrochloride TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-12-26

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:786dbcd5-f5c2-4491-e053-2991aa0a3437
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092189

    • NDC Crossover Matching brand name "Acetaminophen, Diphenhydramine Hydrochloride" or generic name "Acetaminophen, Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    0536-1173Acetaminophen, Diphenhydramine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride
    0904-6731Acetaminophen, Diphenhydramine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride
    57344-101Acetaminophen, Diphenhydramine HydrochlorideACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE
    70000-0411Acetaminophen, Diphenhydramine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride
    70518-2740Acetaminophen, Diphenhydramine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride
    58602-216Aurophen Pain Away plus Sleep aidacetaminophen, diphenhydramine hydrochloride
    58602-217Aurophen Pain Away plus Sleep aidacetaminophen, diphenhydramine hydrochloride
    62011-0024Extra Strength Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
    0904-7651Extra Strength Mapap PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
    59726-360Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
    68016-705Nighttime Pain Plus Sleepacetaminophen, diphenhydramine hydrochloride
    0363-8590NightTime Pain Reliever PMacetaminophen, diphenhydramine hydrochloride
    10202-946Pain Away plus Sleep aidacetaminophen, diphenhydramine hydrochloride
    68016-730Pain Away plus Sleep aidacetaminophen, diphenhydramine hydrochloride
    46122-358Pain Plus Sleepacetaminophen, diphenhydramine hydrochloride
    55910-996Pain Relief plus Sleep Aidacetaminophen, diphenhydramine hydrochloride
    53943-028Pain Relief PMacetaminophen, diphenhydramine hydrochloride
    55319-998Pain Relief PMacetaminophen, diphenhydramine hydrochloride
    59779-905Pain Relief PMacetaminophen, diphenhydramine hydrochloride
    54257-278Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
    50269-608Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
    67414-608Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
    67751-168Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
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