NDC 70000-0168

Leader Cold Relief

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl

Leader Cold Relief is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID70000-0168_1256b05b-7470-487c-83ac-f5f9e1f13d5a
NDC70000-0168
Product TypeHuman Otc Drug
Proprietary NameLeader Cold Relief
Generic NameAcetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-12-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCardinal Health
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0168-1

12 BLISTER PACK in 1 CARTON (70000-0168-1) > 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2016-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0168-1 [70000016801]

Leader Cold Relief TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2016-12-07

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:e6e2381d-3ba6-4127-a6ee-82e9f232474b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094538

    • Medicade Reported Pricing

    70000016801 DAYTIME COLD RELIEF CAPLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Leader Cold Relief" or generic name "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    70000-0168Leader Cold ReliefLeader Cold Relief
    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.