NDC 36800-459

topcare nite time cold and flu relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

topcare nite time cold and flu relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

• Product ID: 36800-459_9178c9ac-77bc-45ca-82a3-d47244681f5b
• NDC: 36800-459
• Product Type: Human Otc Drug
• Proprietary Name: topcare nite time cold and flu relief
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2011-08-19
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Topco Associates LLC
• 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 36800-459-34

237 mL in 1 BOTTLE (36800-459-34)

• Marketing Start Date: 2012-07-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-459-34 [36800045934]

topcare nite time cold and flu relief SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-11

NDC 36800-459-38 [36800045938]

topcare nite time cold and flu relief SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-08-31
• Marketing End Date: 2013-10-18

NDC 36800-459-30 [36800045930]

topcare nite time cold and flu relief SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-08-19
• Marketing End Date: 2013-11-16

NDC 36800-459-40 [36800045940]

topcare nite time cold and flu relief SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-10

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: f868e4a0-e9fb-4e6a-9984-29a218246241
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1043400
• UPC Code:
  • 0036800367234

NDC Crossover Matching brand name "topcare nite time cold and flu relief" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate"

NDC	Brand Name	Generic Name
36800-459	topcare nite time cold and flu relief	topcare nite time cold and flu relief
36800-335	topcare nite time cold and flu relief	topcare nite time cold and flu relief
36800-872	Topcare Nite Time Cold and flu relief	Topcare Nite Time Cold and flu relief
10202-056	7 select night time relief	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
10202-335	7 select night time relief	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0904-6465	all nite	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0113-7459	Basic Care Nighttime	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0113-7056	Basic Care Nighttime Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0363-0401	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0363-0566	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0363-0917	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0363-6600	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
0363-7311	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
0363-9913	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
15127-343	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
15127-344	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
15127-660	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0113-0056	good sense night time	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0113-0335	good sense night time	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
0113-0459	good sense nighttime	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
11822-3335	Night Time Cold and Flu Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
11822-3392	Night Time Cold and Flu Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
0363-9975	Nighttime Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
0363-9976	Nighttime Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
11788-017	Nighttime Cold and Flu Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
11822-0335	nighttime cold and flu relief	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
11822-0459	nighttime cold and flu relief	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
21130-899	Nighttime Cold and Flu Relief	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
11673-019	up and up nighttime cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
11673-500	up and up nighttime cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
11673-626	up and up nighttime cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate