NDC 58602-148

AuroQuil Severe Cold and Flu Nighttime Relief

Acetaminophen, Phenylephrine Hcl, Doxylamine Succinate And Dextromethorphan Hbr

AuroQuil Severe Cold and Flu Nighttime Relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID58602-148_96cb9aeb-7bdf-492c-b6d2-577412af400c
NDC58602-148
Product TypeHuman Otc Drug
Proprietary NameAuroQuil Severe Cold and Flu Nighttime Relief
Generic NameAcetaminophen, Phenylephrine Hcl, Doxylamine Succinate And Dextromethorphan Hbr
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-05-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAurohealth LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58602-148-20

237 mL in 1 BOTTLE (58602-148-20)
Marketing Start Date2015-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-148-20 [58602014820]

AuroQuil Severe Cold and Flu Nighttime Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-31

NDC 58602-148-16 [58602014816]

AuroQuil Severe Cold and Flu Nighttime Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:f77048ef-2a8b-4167-b033-984370e80d1e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1431245

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