NDC 67091-331

Fast Acting Cold, Flu and Sore Throat Relief

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride

Fast Acting Cold, Flu and Sore Throat Relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Winco Foods, Llc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 67091-331_2dfa5df2-8646-4ed2-8720-a29f95964dea
• NDC: 67091-331
• Product Type: Human Otc Drug
• Proprietary Name: Fast Acting Cold, Flu and Sore Throat Relief
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Winco Foods, LLC.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/20mL; mg/20mL; mg/20mL; mg/20mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67091-331-06

180 mL in 1 BOTTLE (67091-331-06)

• Marketing Start Date: 2015-08-11
• Marketing End Date: 2022-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67091-331-06 [67091033106]

Fast Acting Cold, Flu and Sore Throat Relief SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-08-11

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL

OpenFDA Data

• SPL SET ID: 2dfa5df2-8646-4ed2-8720-a29f95964dea
• Manufacturer:
  • Winco Foods, LLC.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1116572

NDC Crossover Matching brand name "Fast Acting Cold, Flu and Sore Throat Relief" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
67091-331	Fast Acting Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58602-157	Auro Mucus - Childrens Cold, Cough and Sore Throat	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58602-110	AuroMucus - Fast Maximum Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58602-518	Childrens Cold, Cough and Sore Throat	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
69842-006	CVS - Childrens Mucus Relief Cough, Cold and Sore Throat	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
49738-995	KMart - Fast Maximum Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58602-504	Primary Health - Fast Maximum Cold, Flu and Sore Throat Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
50066-916	TUKOL MAX ACTION COLD SORE THROAT AND COUGH	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
58933-540	Vicks DayQuil Severe Hot Remedy	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin and phenylephrine hydrochloride
69423-976	Vicks DayQuil Severe Hot Remedy	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin and phenylephrine hydrochloride
0363-8592	Walgreens Severe Warming Cold and Flu For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride