NDC 50844-005

Cold, Flu and Sore Throat Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Cold, Flu and Sore Throat Maximum Strength is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by L.n.k. International, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID50844-005_2aac5c7a-e7b1-4bd4-9ebe-216407f35681
NDC50844-005
Product TypeHuman Otc Drug
Proprietary NameCold, Flu and Sore Throat Maximum Strength
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2017-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameL.N.K. International, Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/20mL; mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50844-005-45

177 mL in 1 BOTTLE, PLASTIC (50844-005-45)
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50844-005-45 [50844000545]

Cold, Flu and Sore Throat Maximum Strength LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:1876f1db-1a82-4692-8d29-a4b764064c80
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116572
  • UPC Code
  • 0350844005458
  • NDC Crossover Matching brand name "Cold, Flu and Sore Throat Maximum Strength" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    50844-005Cold, Flu and Sore Throat Maximum StrengthCold, Flu and Sore Throat Maximum Strength
    59779-916Cold, Flu and Sore Throat Maximum StrengthCold, Flu and Sore Throat Maximum Strength
    0113-7603Basic Care Daytime Cold and Flu Severeacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-7303basic care mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0640Cold and FluAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0299good sense cold and flu severeAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0234good sense cold head congestionAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0381Good Sense Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-1913good sense mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0579good sense severe coldAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0548Good Sense Severe Daytimeacetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0603Good Sense Severe Daytime Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-9007Good Sense Severe Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0363-0616Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0538Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0719Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0372Mucus Relief PlusAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0410Mucus Relief Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0503Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0603Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0363-0524Sinus ReliefAcetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
    0067-8145Theraflu ExpressMax Severe Cold and Flu CapletsAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0067-8132Theraflu ExpressMax Severe Cold and Flu SyrupAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0051Wal Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl

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