sudafed pe head congestion plus pain

Generic: ibuprofen and phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

ibuprofen 200 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-436
Product ID 50580-436_2ffbcc44-0ef3-b149-e063-6394a90ae7f5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203200
Listing Expiration 2026-12-31
Marketing Start 2019-06-17

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580436
Hyphenated Format 50580-436

Supplemental Identifiers

RxCUI
1369775
UPC
0300450551207
UNII
WK2XYI10QM 04JA59TNSJ
NUI
N0000000160 M0001335 N0000175722

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 head congestion plus pain (source: ndc)
Generic Name ibuprofen and phenylephrine hydrochloride (source: ndc)
Application Number ANDA203200 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

50580-436-01 2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

ibuprofen (200 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Sudafed PE Head Congestion Plus Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ffbcc44-0ef3-b149-e063-6394a90ae7f5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0300450551207"], "unii": ["WK2XYI10QM", "04JA59TNSJ"], "rxcui": ["1369775"], "spl_set_id": ["76513fb2-7323-4f1f-8a10-92f8f603cf97"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-436-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-436-01", "marketing_start_date": "20190617"}], "brand_name": "Sudafed PE Head Congestion Plus Pain", "product_id": "50580-436_2ffbcc44-0ef3-b149-e063-6394a90ae7f5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "50580-436", "generic_name": "Ibuprofen and Phenylephrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sudafed PE Head Congestion Plus Pain", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA203200", "marketing_category": "ANDA", "marketing_start_date": "20190617", "listing_expiration_date": "20261231"}