NDC 0113-7335

basic care nighttime cold and flu

Acetaminophen, Dextromethorphan Hdrobromide, Doxylamine Succinate

basic care nighttime cold and flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by L. Perrigo Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID0113-7335_90059a53-9b30-465c-9c59-9355163e9101
NDC0113-7335
Product TypeHuman Otc Drug
Proprietary Namebasic care nighttime cold and flu
Generic NameAcetaminophen, Dextromethorphan Hdrobromide, Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-01-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameL. Perrigo Company
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 0113-7335-40

355 mL in 1 BOTTLE (0113-7335-40)
Marketing Start Date2019-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0113-7335-40 [00113733540]

basic care nighttime cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-16

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:90059a53-9b30-465c-9c59-9355163e9101
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400
  • NDC Crossover Matching brand name "basic care nighttime cold and flu" or generic name "Acetaminophen, Dextromethorphan Hdrobromide, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    0113-7056Basic Care Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-7335basic care nighttime cold and fluAcetaminophen, Dextromethorphan Hdrobromide, Doxylamine succinate
    0113-7501basic care nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    72288-056basic care nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    72288-335basic care nighttime cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    72288-459basic care nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate

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