NDC 55315-358

COLD and FLU Nighttime Relief

Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr

COLD and FLU Nighttime Relief 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; Doxylamine Succinate.

• Product ID: 55315-358_17611218-40d9-477e-9163-42a7f6a0f044
• NDC: 55315-358
• Product Type: Human Otc Drug
• Proprietary Name: COLD and FLU Nighttime Relief
• Generic Name: Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-24
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Fred's, Inc.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55315-358-31

355 mL in 1 BOTTLE (55315-358-31)

• Marketing Start Date: 2015-08-24
• Marketing End Date: 2021-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55315-358-31 [55315035831]

COLD and FLU Nighttime Relief SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-08-24

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: f06092de-abc3-49c4-9425-d6c64b45ce9b
• Manufacturer:
  • Fred's, Inc.
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1043400
• UPC Code:
  • 0084579128273

NDC Crossover Matching brand name "COLD and FLU Nighttime Relief" or generic name "Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr"

NDC	Brand Name	Generic Name
50844-252	Cold and Flu Nighttime Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
50844-266	Cold and Flu Nighttime Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
50844-793	Cold and Flu Nighttime Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
55315-357	COLD and FLU Nighttime Relief	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
55315-358	COLD and FLU Nighttime Relief	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
58602-508	Cold and Flu Nighttime Relief	acetaminophen, doxylamine succinate, and dextromethorphan hbr solution
68016-707	COLD and FLU Nighttime Relief	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
68016-709	COLD and FLU Nighttime Relief	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
68016-710	COLD and FLU Nighttime Relief	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
71141-138	Cold and Flu Nighttime Relief	Cold and Flu Nighttime Relief
55315-342	Cold and Flu Nighttime Relief	Cold and Flu Nighttime Relief
55315-344	Cold and Flu Nighttime Relief	Cold and Flu Nighttime Relief
58602-136	AuroQuil COLD and FLU Nighttime Relief	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
58602-137	AuroQuil Cold and Flu Nighttime Relief	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
68998-531	Night Time Cold and Flu Original	Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr