NDC 55316-335

healthy accents nighttime cold and flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

healthy accents nighttime cold and flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID55316-335_9e6810bb-464d-456f-b899-d950aca8d6ce
NDC55316-335
Product TypeHuman Otc Drug
Proprietary Namehealthy accents nighttime cold and flu
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-09-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDZA Brands LLC
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 55316-335-40

355 mL in 1 BOTTLE (55316-335-40)
Marketing Start Date2012-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-335-40 [55316033540]

healthy accents nighttime cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-09-20

NDC 55316-335-34 [55316033534]

healthy accents nighttime cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-10

NDC 55316-335-30 [55316033530]

healthy accents nighttime cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-10-24

NDC 55316-335-38 [55316033538]

healthy accents nighttime cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-22

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:1161b4bd-d011-435d-9e10-0796842659ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400
  • UPC Code
  • 0725439959131
  • NDC Crossover Matching brand name "healthy accents nighttime cold and flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    55316-459healthy accents nighttime cold and fluhealthy accents nighttime cold and flu
    55316-335healthy accents nighttime cold and fluhealthy accents nighttime cold and flu
    55316-056healthy accents nighttime cold and fluhealthy accents nighttime cold and flu
    10202-0567 select night time reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    10202-3357 select night time reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0904-6465all niteAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-7459Basic Care NighttimeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-7056Basic Care Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0401Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0566Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0917Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-6600Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-7311Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-9913Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    15127-343Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    15127-344Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    15127-660Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0056good sense night timeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0335good sense night timeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0459good sense nighttimeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11822-3335Night Time Cold and Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    11822-3392Night Time Cold and Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-9975Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-9976Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    11788-017Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11822-0335nighttime cold and flu reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11822-0459nighttime cold and flu reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    21130-899Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    11673-019up and up nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11673-500up and up nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11673-626up and up nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate

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