NDC 50580-435

Sudafed PE Sinus Pressure Plus Pain

Acetaminophen And Phenylephrine Hydrochloride

Sudafed PE Sinus Pressure Plus Pain 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; Phenylephrine Hydrochloride.

Product ID50580-435_43e1172c-f361-4071-84ba-7afbc3295fa6
NDC50580-435
Product TypeHuman Otc Drug
Proprietary NameSudafed PE Sinus Pressure Plus Pain
Generic NameAcetaminophen 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; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-435-01

2 BLISTER PACK in 1 CARTON (50580-435-01) > 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 50580-435-01 [50580043501]

Sudafed PE Sinus Pressure Plus Pain 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:60183922-bfd3-4377-884a-51b2f0a4c93a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046378
  • 1101529

    • NDC Crossover Matching brand name "Sudafed PE Sinus Pressure Plus Pain" or generic name "Acetaminophen And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-435Sudafed PE Sinus Pressure Plus PainAcetaminophen and Phenylephrine hydrochloride
    46017-024Contac Cold and Fluacetaminophen and phenylephrine hydrochloride
    46017-021Contac Cold and Flu Dayacetaminophen and phenylephrine hydrochloride
    50804-100Daytime sinusAcetaminophen and Phenylephrine Hydrochloride
    33992-1100Daytime Sinus ReliefAcetaminophen and Phenylephrine Hydrochloride
    36800-098Daytime Sinus ReliefAcetaminophen and Phenylephrine Hydrochloride
    36800-911Pressure and Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-220Pressure and Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    50804-003Pressure Plus Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    50804-476Pressure plus Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-623sinus and headacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    46122-658Sinus and HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    50804-123Sinus and HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41520-099Sinus DaytimeAcetaminophen and Phenylephrine Hydrochloride
    46122-453Sinus HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    36800-322Sinus plus HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-534Sinus plus HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-207sinus pressure and pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    50804-220sinus pressure and pain peACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    36800-320Sinus Pressure plus Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    50580-547SUDAFED PE Pressure Plus Painacetaminophen and phenylephrine hydrochloride
    50580-598TYLENOL SINUS PLUS HEADACHEAcetaminophen and Phenylephrine hydrochloride
    37000-507Vicks SinexAcetaminophen and Phenylephrine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.