NDC 76281-305

XL-3 Xtreme

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

XL-3 Xtreme is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Aptapharma Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID76281-305_b4c7533a-0bf4-4568-bab3-764e49621fa7
NDC76281-305
Product TypeHuman Otc Drug
Proprietary NameXL-3 Xtreme
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAptaPharma 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 76281-305-28

354 mL in 1 BOTTLE (76281-305-28)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76281-305-28 [76281030528]

XL-3 Xtreme LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:dff79e0b-edf0-4dd3-a722-fd9beecd6293
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400
  • UPC Code
  • 0645981000290
  • 0645981000351
  • NDC Crossover Matching brand name "XL-3 Xtreme" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    76281-305XL-3 XtremeXL-3 Xtreme
    76281-307XL-3 XtremeXL-3 Xtreme
    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

    Trademark Results [XL-3 Xtreme]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XL-3 XTREME
    XL-3 XTREME
    86177819 4592791 Live/Registered
    Marvi Asesores, S.C.
    2014-01-28

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