NDC 70000-0411

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 Cardinal Health. The primary component is Acetaminophen; Diphenhydramine Hydrochloride.

Product ID70000-0411_7cc30c0f-6a86-c65e-e053-2a91aa0af73f
NDC70000-0411
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen, Diphenhydramine Hydrochloride
Generic NameAcetaminophen, Diphenhydramine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-11-29
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameCardinal Health
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0411-1

1 BOTTLE in 1 CARTON (70000-0411-1) > 24 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2018-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0411-3 [70000041103]

Acetaminophen, Diphenhydramine Hydrochloride TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-12-10

NDC 70000-0411-2 [70000041102]

Acetaminophen, Diphenhydramine Hydrochloride TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-11-29

NDC 70000-0411-1 [70000041101]

Acetaminophen, Diphenhydramine Hydrochloride TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-12-10

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:7be4d67e-1af9-f059-e053-2991aa0a382e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092189
  • UPC Code
  • 0096295135282
  • 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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