NDC 50580-546

Sudafed PE Congestion

Phenylephrine Hydrochloride

Sudafed PE Congestion is a Oral Tablet 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 ID50580-546_6251fa24-d4f3-4e41-a873-25188c2334fe
NDC50580-546
Product TypeHuman Otc Drug
Proprietary NameSudafed PE Congestion
Generic NamePhenylephrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-13
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 50580-546-50

1 BLISTER PACK in 1 CARTON (50580-546-50) > 18 TABLET in 1 BLISTER PACK
Marketing Start Date2015-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-546-51 [50580054651]

Sudafed PE Congestion TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

NDC 50580-546-50 [50580054650]

Sudafed PE Congestion TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:74716ae2-b035-47e2-9fc6-9ce53fdcd790
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1052767
  • 1049182

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

    NDCBrand NameGeneric Name
    50580-546Sudafed PE CongestionSudafed PE 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

    Trademark Results [Sudafed PE Congestion]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SUDAFED PE CONGESTION
    SUDAFED PE CONGESTION
    86331009 4909543 Live/Registered
    JOHNSON & JOHNSON
    2014-07-08
    SUDAFED PE CONGESTION
    SUDAFED PE CONGESTION
    85090372 not registered Dead/Abandoned
    JOHNSON & JOHNSON
    2010-07-22
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