NDC 69848-014

Acetaminophen Diphenhydramine HCl

Acetaminophen Diphenhydramine Hcl

Acetaminophen Diphenhydramine HCl is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Granules Usa, Inc.. The primary component is Diphenhydramine Hydrochloride; Acetaminophen.

Product ID69848-014_8c9f68e3-fedd-6457-e053-2995a90a045a
NDC69848-014
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen Diphenhydramine HCl
Generic NameAcetaminophen Diphenhydramine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameGranules USA, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength25 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69848-014-02

20 TABLET in 1 BOTTLE (69848-014-02)
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69848-014-02 [69848001402]

Acetaminophen Diphenhydramine HCl TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-01

NDC 69848-014-05 [69848001405]

Acetaminophen Diphenhydramine HCl TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-01

NDC 69848-014-15 [69848001415]

Acetaminophen Diphenhydramine HCl TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:8c9f68e3-fedc-6457-e053-2995a90a045a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092189
  • NDC Crossover Matching brand name "Acetaminophen Diphenhydramine HCl" or generic name "Acetaminophen Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    0363-9664Acetaminophen Diphenhydramine HCLAcetaminophen Diphenhydramine HCL
    0363-9991Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    21130-354Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    55315-988Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    55315-990Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    68016-651Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    68016-654Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    68016-659Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    69842-306Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    69842-308Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    69848-014Acetaminophen Diphenhydramine HClAcetaminophen Diphenhydramine HCl
    59726-863Pain Reliever PMAcetaminophen Diphenhydramine HCL
    59726-868Pain Reliever PMAcetaminophen Diphenhydramine HCL

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