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 ID57243-501_2967e3a3-33bf-45fd-b164-fb845db392e9
NDC57243-501
Product TypeHuman Otc Drug
Proprietary NameNite-Time COLD/FLU ORIGINAL
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-01-16
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameSalado Sales, Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57243-501-25

177 mL in 1 BOTTLE (57243-501-25)
Marketing Start Date2012-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57243-501-25 [57243050125]

Nite-Time COLD/FLU ORIGINAL LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-16

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:fcd24753-b42b-4d05-8379-0ec0351ab217
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400
  • NDC Crossover Matching brand name "Nite-Time COLD/FLU ORIGINAL" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    57243-501Nite-Time COLD/FLU ORIGINALNite-Time COLD/FLU ORIGINAL
    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

    Trademark Results [Nite-Time]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NITE-TIME
    NITE-TIME
    85359292 4448185 Live/Registered
    Northeast Textiles, Inc.
    2011-06-29

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.