NDC 50580-450

SUDAFED PE Head Congestion Plus Flu Severe

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

SUDAFED PE Head Congestion 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 ID50580-450_212e35b2-d229-400b-a303-f8988b01d1e7
NDC50580-450
Product TypeHuman Otc Drug
Proprietary NameSUDAFED PE Head Congestion Plus Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-17
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 Through2020-12-31

Packaging

NDC 50580-450-01

2 BLISTER PACK in 1 CARTON (50580-450-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-450-01 [50580045001]

SUDAFED PE Head Congestion Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-17

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:1e528f78-0ced-4a06-935a-84056c921727
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098435
  • NDC Crossover Matching brand name "SUDAFED PE Head Congestion Plus Flu Severe" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-450SUDAFED PE Head Congestion Plus Flu SevereSUDAFED PE Head Congestion 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
    37808-497Mucus 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

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