NDC 50580-437

Sudafed PE Sinus Congestion

Phenylephrine Hydrochloride

Sudafed PE Sinus Congestion 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 Phenylephrine Hydrochloride.

Product ID50580-437_9711b044-0b6e-4e5b-86d7-32e44e9e8a31
NDC50580-437
Product TypeHuman Otc Drug
Proprietary NameSudafed PE Sinus Congestion
Generic NamePhenylephrine 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 NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-437-01

1 BLISTER PACK in 1 CARTON (50580-437-01) > 18 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-437-02 [50580043702]

Sudafed PE Sinus Congestion TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-17

NDC 50580-437-01 [50580043701]

Sudafed PE Sinus Congestion TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-17

NDC 50580-437-03 [50580043703]

Sudafed PE Sinus Congestion TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-03

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:2ca08917-1a75-4365-8520-c083e6a4225a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1052767
  • 1049182
    • UPC Code
  • 0300450581365

    • NDC Crossover Matching brand name "Sudafed PE Sinus Congestion" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-239SUDAFED PE SINUS CONGESTIONSUDAFED PE SINUS CONGESTION
    50580-437Sudafed PE Sinus CongestionSudafed PE Sinus Congestion
    0067-20864 WayPhenylephrine hydrochloride
    0113-7094basic care sinus pePhenylephrine Hydrochloride
    0363-0390ephrine nosePhenylephrine hydrochloride
    0363-2023Ephrine Nose DropsPhenylephrine hydrochloride
    0113-0094Good Sense Nasal Decongestant PEPhenylephrine Hydrochloride
    0113-0648Good Sense Nasal FourPhenylephrine hydrochloride
    0295-1217Little Remedies Decongestant Nose DropsPhenylephrine Hydrochloride
    0363-0717nasalPhenylephrine hydrochloride
    0295-1117Neo-SynephrinePhenylephrine hydrochloride
    0295-1118Neo-SynephrinePhenylephrine hydrochloride
    0295-1119Neo-SynephrinePhenylephrine hydrochloride
    0225-0800Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDE
    0225-0805Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0225-0810Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0363-0394phenylephrine hydrochloridephenylephrine hydrochloride
    0404-9931Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6142Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6188Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6189Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6229Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3422Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3458Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0113-2004sinus PEPhenylephrine Hydrochloride
    0363-0648Wal FourPhenylephrine hydrochloride
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