NDC 53441-346

Nighttime Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

Nighttime Cold and Flu is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by National Distribution Network (smart Choice). The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID53441-346_56678e0c-e686-42f8-adc3-3ec6df070a71
NDC53441-346
Product TypeHuman Otc Drug
Proprietary NameNighttime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-06-30
Marketing End Date2020-01-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameNational Distribution Network (Smart Choice)
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN

Packaging

NDC 53441-346-06

177 mL in 1 BOTTLE (53441-346-06)
Marketing Start Date2014-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53441-346-06 [53441034606]

Nighttime Cold and Flu LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-06-30
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

NDC Crossover Matching brand name "Nighttime Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate"

NDCBrand NameGeneric Name
0363-0460Nighttime Cold and FluAcetaminophen, Diphenhydramine HCI, Phenylephrine HCI
0363-0850Nighttime Cold and FluAcetaminophen Dextromethorphan HBr Doxylamine succinate
0363-1011NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
0363-1141nighttime cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
0363-9975Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
0363-9976Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
11673-460Nighttime Cold and FluAcetaminophen, Diphenhydramine HCI, Phenylephrine HCI
11822-3318Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11822-6859Nighttime Cold and FluAcetaminophen Diphenhydramine HCl Phenylephrine HCl
15127-987Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
70005-005NIGHTTIME COLD AND FLUNIGHTTIME COLD AND FLU
76168-056NightTime Cold and FluNightTime Cold and Flu
37012-335Nighttime Cold and FluNighttime Cold and Flu
37835-952NIGHTTIME COLD AND FLUNIGHTTIME COLD AND FLU
49035-041Nighttime Cold and FluNighttime Cold and Flu
49348-157Nighttime cold and fluNighttime cold and flu
49738-480Nighttime cold and fluNighttime cold and flu
50804-480Nighttime cold and fluNighttime cold and flu
51013-193Nighttime Cold and FluNighttime Cold and Flu
51013-147NIGHTTIME COLD and FLUNIGHTTIME COLD and FLU
51013-131NIGHTTIME COLD and FLUNIGHTTIME COLD and FLU
53345-006Nighttime Cold and FluNighttime Cold and Flu
53441-342Nighttime Cold and FluNighttime Cold and Flu
53441-346Nighttime Cold and FluNighttime Cold and Flu
53345-026Nighttime Cold and FluNighttime Cold and Flu
53441-343Nighttime Cold and FluNighttime Cold and Flu
55316-012Nighttime Cold and FluNighttime Cold and Flu
63868-219Nighttime Cold and FluNighttime Cold and Flu
46994-344Nighttime Cold and FluNighttime Cold and Flu
66715-6716Nighttime Cold and FluNighttime Cold and Flu
66715-6816Nighttime Cold and FluNighttime Cold and Flu
41250-586NightTime Cold and FluNightTime Cold and Flu
0363-3430Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
15127-346Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11822-5832Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11523-0077Coricidin HBP Maximum Strength Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate
0904-5764Major Night Time Multi SymptomAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11822-0403Night TimeAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
11822-1403Night Time CherryAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
0904-6996Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
11822-1406Night Time OriginalAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
0363-1005nighttime cold and flu reliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
15127-139Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
14505-399SanatosAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.