NDC 55301-543

NiteTime Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

NiteTime Cold and Flu is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Aafes/your Military Exchanges. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID55301-543_5f48b6a7-2279-448b-a7a8-456410a67513
NDC55301-543
Product TypeHuman Otc Drug
Proprietary NameNiteTime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2017-12-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAAFES/Your Military Exchanges
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
Pharm ClassesAntihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55301-543-12

355 mL in 1 BOTTLE, PLASTIC (55301-543-12)
Marketing Start Date2017-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55301-543-12 [55301054312]

NiteTime Cold and Flu LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:e63814bb-de0d-4582-b4f5-9ff5be1e53e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400
    • UPC Code
  • 0614299405585

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

    NDCBrand NameGeneric Name
    41250-763Nitetime Cold and FluNitetime Cold and Flu
    41250-335nitetime cold and flunitetime cold and flu
    41250-872nitetime cold and flunitetime cold and flu
    41250-811nitetime cold and flunitetime cold and flu
    41250-459nitetime cold and flunitetime cold and flu
    49035-044NiteTime Cold and FluNiteTime Cold and Flu
    51013-184Nitetime Cold and FluNitetime Cold and Flu
    55301-543NiteTime Cold and FluNiteTime 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
    21130-071Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
    21130-849Cold 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
    0363-1141nighttime cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    11822-3318Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    15127-987Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    0363-1005nighttime cold and flu reliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    15127-139Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    21130-044Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    21130-343Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    21130-480Safeway Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
    14505-399SanatosAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
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