NDC 55315-359

Daytime Relief Severe Cold and Flu

Acetaminophen, Phenylephrine Hcl, Dextromethorphan Hbr And Guaifenesin

Daytime Relief Severe Cold and Flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 55315-359_b406f10d-c447-433c-87d8-991632de7706
• NDC: 55315-359
• Product Type: Human Otc Drug
• Proprietary Name: Daytime Relief Severe Cold and Flu
• Generic Name: Acetaminophen, Phenylephrine Hcl, Dextromethorphan Hbr And Guaifenesin
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2015-06-26
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Fred's, Inc.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55315-359-31

354 mL in 1 BOTTLE (55315-359-31)

• Marketing Start Date: 2015-06-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55315-359-31 [55315035931]

Daytime Relief Severe Cold and Flu SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-06-26

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL

OpenFDA Data

• SPL SET ID: 6eb28714-3b79-4eaf-b1af-1be103826347
• Manufacturer:
  • Fred's, Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1369842

NDC Crossover Matching brand name "Daytime Relief Severe Cold and Flu" or generic name "Acetaminophen, Phenylephrine Hcl, Dextromethorphan Hbr And Guaifenesin"

NDC	Brand Name	Generic Name
55315-359	Daytime Relief Severe Cold and Flu	acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin
58602-149	AuroQuil Severe Cold and Flu Daytime Relief	acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin
33992-0503	Cold Multi-Symptom	Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin
68210-4166	Non-Drowsy Daytime Severe Cold Multi-Symptom	Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin