sudafed sinus 12 hour pressure plus pain

Generic: naproxen sodium and pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name sudafed sinus 12 hour pressure plus pain
Generic Name naproxen sodium and pseudoephedrine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-434
Product ID 50580-434_21abbf03-2010-4650-e063-6294a90a6edb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076518
Listing Expiration 2026-12-31
Marketing Start 2019-06-17

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580434
Hyphenated Format 50580-434

Supplemental Identifiers

RxCUI
1367426
UPC
0300450358165
UNII
9TN87S3A3C 6V9V2RYJ8N

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 sinus 12 hour pressure plus pain (source: ndc)
Generic Name naproxen sodium and pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA076518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

50580-434-01 2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

naproxen sodium (220 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Sudafed Sinus 12 Hour Pressure plus Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21abbf03-2010-4650-e063-6294a90a6edb", "openfda": {"upc": ["0300450358165"], "unii": ["9TN87S3A3C", "6V9V2RYJ8N"], "rxcui": ["1367426"], "spl_set_id": ["305adca3-cdae-41e5-a10a-99d9dd0fe390"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-434-01)  / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "50580-434-01", "marketing_start_date": "20190617"}], "brand_name": "Sudafed Sinus 12 Hour Pressure plus Pain", "product_id": "50580-434_21abbf03-2010-4650-e063-6294a90a6edb", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50580-434", "generic_name": "Naproxen sodium and Pseudoephedrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sudafed Sinus 12 Hour Pressure plus Pain", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA076518", "marketing_category": "ANDA", "marketing_start_date": "20190617", "listing_expiration_date": "20261231"}