NDC 76281-306

XL-3 Day Time

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl

XL-3 Day Time 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; Phenylephrine Hydrochloride.

Product ID76281-306_617e63a9-c9f9-4d75-ae8a-e5e3cdf8f977
NDC76281-306
Product TypeHuman Otc Drug
Proprietary NameXL-3 Day Time
Generic NameAcetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-09-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAptaPharma Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76281-306-25

177 mL in 1 BOTTLE, PLASTIC (76281-306-25)
Marketing Start Date2018-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76281-306-25 [76281030625]

XL-3 Day Time LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:94e02be4-b8a6-422a-8f66-e6a69e924b2c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705
    • UPC Code
  • 0645981000368

    • NDC Crossover Matching brand name "XL-3 Day Time" or generic name "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    76281-306XL-3 Day TimeXL-3 Day Time
    76281-304XL-3 Day TimeXL-3 Day Time
    0113-7994basic care daytime cold and fluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0113-7690basic care severe cold and fluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-0560ColdAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-0666Cold and Fluacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0363-6590Cold and FluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-7301Cold and FluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0067-2077COMTREXAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-0656Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0113-0064Good Sense Cold MaxAcetaminophen, Dextromethorphan hbr, Phenylephrine hcl
    0113-0656Good Sense Daytimeacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0113-0994good sense daytimeAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0113-0023good sense multi symptom flu and severe coldAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-5470Multi Symptom Wal Flu Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    0067-6426THERAFLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    0067-8127Theraflu ExpressMaxAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0067-8136Theraflu ExpressMaxacetaminophen, dextromethorphan HBr, phenylephrine HCl
    0363-8319wal flu severe coldAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-5110Wal-PhedAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.