sudafed pe sinus congestion

Generic: phenylephrine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sudafed pe sinus congestion
Generic Name phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

phenylephrine hydrochloride 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-437
Product ID 50580-437_21ad7bba-a836-8d9d-e063-6294a90a371d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-06-17

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580437
Hyphenated Format 50580-437

Supplemental Identifiers

RxCUI
1049182 1052767
UPC
0300450581365
UNII
04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sudafed pe sinus congestion (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50580-437-01) / 18 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50580-437-02) / 18 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 CARTON in 1 PACKAGE (50580-437-03) / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

50580-437-01 1 BLISTER PACK in 1 CARTON (50580-437-01) / 18 TABLET, FILM COATED in 1 BLISTER PACK 50580-437-02 2 BLISTER PACK in 1 CARTON (50580-437-02) / 18 TABLET, FILM COATED in 1 BLISTER PACK 50580-437-03 3 CARTON in 1 PACKAGE (50580-437-03) / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Sudafed PE Sinus Congestion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21ad7bba-a836-8d9d-e063-6294a90a371d", "openfda": {"upc": ["0300450581365"], "unii": ["04JA59TNSJ"], "rxcui": ["1049182", "1052767"], "spl_set_id": ["2ca08917-1a75-4365-8520-c083e6a4225a"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50580-437-01)  / 18 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-437-01", "marketing_start_date": "20190617"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-437-02)  / 18 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-437-02", "marketing_start_date": "20190617"}, {"sample": false, "description": "3 CARTON in 1 PACKAGE (50580-437-03)  / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-437-03", "marketing_start_date": "20190903"}], "brand_name": "Sudafed PE Sinus Congestion", "product_id": "50580-437_21ad7bba-a836-8d9d-e063-6294a90a371d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "50580-437", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sudafed PE Sinus Congestion", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190617", "listing_expiration_date": "20261231"}