NDC 58602-216

Aurophen Pain Away plus Sleep aid

Acetaminophen, Diphenhydramine Hydrochloride

Aurophen Pain Away plus Sleep aid is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride.

Product ID58602-216_1a5877be-c04a-4b5b-bff5-da76d1c3fa0d
NDC58602-216
Product TypeHuman Otc Drug
Proprietary NameAurophen Pain Away plus Sleep aid
Generic NameAcetaminophen, Diphenhydramine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-03-27
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameAurohealth LLC
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength500 mg/15mL; mg/15mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58602-216-20

1 BOTTLE in 1 CARTON (58602-216-20) > 237 mL in 1 BOTTLE
Marketing Start Date2015-03-27
Marketing End Date2022-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-216-20 [58602021620]

Aurophen Pain Away plus Sleep aid LIQUID
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-03-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/15mL

OpenFDA Data

SPL SET ID:a3fba538-0f4a-4816-b7ed-a944975f544f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1092373
  • NDC Crossover Matching brand name "Aurophen Pain Away plus Sleep aid" or generic name "Acetaminophen, Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    58602-216Aurophen Pain Away plus Sleep aidacetaminophen, diphenhydramine hydrochloride
    58602-217Aurophen Pain Away plus Sleep aidacetaminophen, diphenhydramine hydrochloride
    0536-1173Acetaminophen, Diphenhydramine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride
    0904-6731Acetaminophen, Diphenhydramine HydrochlorideAcetaminophen, 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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