NDC 50580-402

TYLENOL Cold Plus Flu Severe

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

TYLENOL Cold Plus Flu Severe is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID50580-402_76e2325c-87f5-4d07-856f-5fc0c66e4e9b
NDC50580-402
Product TypeHuman Otc Drug
Proprietary NameTYLENOL Cold Plus Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-09-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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 50580-402-01

2 TABLET, FILM COATED in 1 POUCH (50580-402-01)
Marketing Start Date2017-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-402-26 [50580040226]

TYLENOL Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2012-07-11

NDC 50580-402-02 [50580040202]

TYLENOL Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-07

NDC 50580-402-25 [50580040225]

TYLENOL Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-09-01
Marketing End Date2016-01-12

NDC 50580-402-01 [50580040201]

TYLENOL Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-07

NDC 50580-402-72 [50580040272]

TYLENOL Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-07-11

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:efb3bfc5-72e9-4221-8d03-e48f3d8e3821
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988

    • NDC Crossover Matching brand name "TYLENOL Cold Plus Flu Severe" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    29485-8056TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    29485-8058TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    29485-8060TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    29485-8062TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    50580-402TYLENOL Cold Plus Flu SevereTYLENOL Cold Plus Flu Severe
    50580-403TYLENOL COLD PLUS FLU SEVERETYLENOL COLD PLUS FLU SEVERE
    50269-402Tylenol Cold Plus Flu SevereTylenol Cold Plus Flu Severe
    73097-011Tylenol Cold Plus Flu SevereTylenol Cold Plus Flu Severe
    0280-0921Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-502COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-986Cold and Flu Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37000-524DayQuil Severe plus Vicks VapoCoolAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    37808-178DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-474Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-298Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-697Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-764Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-164Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-079Mucus Relief Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-775Pressure Plus Pain PE Plus ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    15127-184Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37000-810Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    37000-811Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    0363-8591Walgreens Severe Cold Multi-Symptom For Adultsacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.