NDC 57243-501

Nite-Time COLD/FLU ORIGINAL

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

Nite-Time COLD/FLU ORIGINAL is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Salado Sales, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

• Product ID: 57243-501_2967e3a3-33bf-45fd-b164-fb845db392e9
• NDC: 57243-501
• Product Type: Human Otc Drug
• Proprietary Name: Nite-Time COLD/FLU ORIGINAL
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2012-01-16
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: Salado Sales, 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: 2020-12-31

Packaging

NDC 57243-501-25

177 mL in 1 BOTTLE (57243-501-25)

• Marketing Start Date: 2012-01-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57243-501-25 [57243050125]

Nite-Time COLD/FLU ORIGINAL LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-01-16

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: fcd24753-b42b-4d05-8379-0ec0351ab217
• Manufacturer:
  • Salado Sales, Inc.
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1043400

NDC Crossover Matching brand name "Nite-Time COLD/FLU ORIGINAL" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate"

NDC	Brand Name	Generic Name
57243-501	Nite-Time COLD/FLU ORIGINAL	Nite-Time COLD/FLU ORIGINAL
0363-3430	Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
15127-346	Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11822-5832	Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
21130-071	Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
21130-849	Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
11523-0077	Coricidin HBP Maximum Strength Nighttime Cold and Flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
0904-5764	Major Night Time Multi Symptom	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11822-0403	Night Time	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11822-1403	Night Time Cherry	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
0904-6996	Night Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
11822-1406	Night Time Original	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
0363-1141	nighttime cold and flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
11822-3318	Nighttime Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
15127-987	Nighttime Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
0363-1005	nighttime cold and flu relief	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
15127-139	Nighttime Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
21130-044	Nighttime Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
21130-343	Nighttime Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
21130-480	Safeway Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
14505-399	Sanatos	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate