sudafed pe pressure plus pain

Generic: acetaminophen and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name sudafed pe pressure plus pain
Generic Name acetaminophen and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-547
Product ID 50580-547_217318f0-e484-c909-e063-6294a90a1bd1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580547
Hyphenated Format 50580-547

Supplemental Identifiers

RxCUI
1046378
UNII
362O9ITL9D 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 pressure plus pain (source: ndc)
Generic Name acetaminophen and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-547-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

50580-547-25 2 BLISTER PACK in 1 CARTON (50580-547-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

acetaminophen (325 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

SUDAFED PE Pressure Plus Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "217318f0-e484-c909-e063-6294a90a1bd1", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["8538c291-9ce9-4866-b268-f4cbdb52f5bd"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-547-25)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-547-25", "marketing_start_date": "20120701"}], "brand_name": "SUDAFED PE Pressure Plus Pain", "product_id": "50580-547_217318f0-e484-c909-e063-6294a90a1bd1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "50580-547", "generic_name": "acetaminophen and phenylephrine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SUDAFED PE Pressure Plus Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120701", "listing_expiration_date": "20261231"}