NDC 55910-619

Cold Flu and Sore Throat Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Cold Flu and Sore Throat Maximum Strength is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Dolgencorp, Inc. (dollar General & Rexall). The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID55910-619_41d0e9ed-474b-4cda-b257-7dd4727fb689
NDC55910-619
Product TypeHuman Otc Drug
Proprietary NameCold Flu and Sore Throat Maximum Strength
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-03-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55910-619-16

16 BLISTER PACK in 1 CARTON (55910-619-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2018-03-31
Marketing End Date2024-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55910-619-16 [55910061916]

Cold Flu and Sore Throat Maximum Strength CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:2c570c48-0f1b-499d-8b0d-60e5d8e71c49
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815
  • UPC Code
  • 0359726519168
  • NDC Crossover Matching brand name "Cold Flu and Sore Throat Maximum Strength" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    55910-619Cold Flu and Sore Throat Maximum StrengthCold Flu and Sore Throat Maximum Strength
    55910-838Cold Flu and Sore Throat Maximum StrengthCold Flu and Sore Throat Maximum Strength
    59779-689Cold 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

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