NDC 0536-3605

Acetaminophen and Diphenhydramine HCl

Acetagesic

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

Product ID0536-3605_411070bc-dca5-4c0a-a574-7d098c0cbefd
NDC0536-3605
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen and Diphenhydramine HCl
Generic NameAcetagesic
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-06-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart343
Labeler NameRugby Laboratories Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength13 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0536-3605-01

100 TABLET in 1 BOTTLE (0536-3605-01)
Marketing Start Date2012-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-3605-01 [00536360501]

Acetaminophen and Diphenhydramine HCl TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2012-06-12
Marketing End Date2017-09-30

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:e49e69ae-3d87-47e4-b486-cfcc8798e991
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1052462

    • NDC Crossover Matching brand name "Acetaminophen and Diphenhydramine HCl" or generic name "Acetagesic"

    NDCBrand NameGeneric Name
    0536-3479Acetaminophen and Diphenhydramine HClAcetaminophen and Diphenhydramine HCl
    0536-3605Acetaminophen and Diphenhydramine HClAcetagesic
    68151-0703Acetaminophen and Diphenhydramine HClAcetaminophen and Diphenhydramine HCl
    49035-235Acetaminophen PMAcetaminophen and Diphenhydramine HCl
    55319-235Acetaminophen PMAcetaminophen and Diphenhydramine HCl
    55319-556Acetaminophen PMAcetaminophen and Diphenhydramine HCl
    58602-743Aurophen PM Extra StrengthAcetaminophen and Diphenhydramine HCl
    37205-759Extra Strength Pain Reliever PMAcetaminophen and Diphenhydramine HCl
    49738-999KMart - Pain Relief PMAcetaminophen and Diphenhydramine HCl
    11822-0556Pain Relief Acetaminophen PMAcetaminophen and Diphenhydramine HCl
    11822-2350Pain Relief Acetaminophen PMAcetaminophen and Diphenhydramine HCl
    21130-556Pain Relief PMAcetaminophen and Diphenhydramine HCl
    49738-655Pain Relief PMAcetaminophen and Diphenhydramine HCl
    55910-655Pain Relief PMAcetaminophen and Diphenhydramine HCl
    15127-325Pain Reliever PMAcetaminophen and Diphenhydramine HCl
    0135-0608PANADOLacetaminophen and diphenhydramine HCl
    0135-7021PANADOLacetaminophen and diphenhydramine HCl
    41250-556Rapid Release Pain Relief PMAcetaminophen and Diphenhydramine HCl
    0363-0235Wal-Nadol PMAcetaminophen and Diphenhydramine HCl
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.