aleve-d sinus and headache

Generic: naproxen sodium, pseudoephedrine hydrochloride

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aleve-d sinus and headache
Generic Name naproxen sodium, pseudoephedrine hydrochloride
Labeler bayer healthcare llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-6045
Product ID 0280-6045_4526bb5e-f2d9-1c3e-e063-6394a90a62ae
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076518
Listing Expiration 2026-12-31
Marketing Start 2014-01-01

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 02806045
Hyphenated Format 0280-6045

Supplemental Identifiers

RxCUI
1367426
UPC
0325866569516
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 aleve-d sinus and headache (source: ndc)
Generic Name naproxen sodium, 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
  • 1 BLISTER PACK in 1 CARTON (0280-6045-10) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0280-6045-10 1 BLISTER PACK in 1 CARTON (0280-6045-10) / 10 TABLET in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Aleve-D Sinus and Headache ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4526bb5e-f2d9-1c3e-e063-6394a90a62ae", "openfda": {"upc": ["0325866569516"], "unii": ["9TN87S3A3C", "6V9V2RYJ8N"], "rxcui": ["1367426"], "spl_set_id": ["5ab980c0-c48a-233b-e053-2991aa0a4fd1"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0280-6045-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0280-6045-10", "marketing_start_date": "20140101"}], "brand_name": "Aleve-D Sinus and Headache", "product_id": "0280-6045_4526bb5e-f2d9-1c3e-e063-6394a90a62ae", "dosage_form": "TABLET", "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": "0280-6045", "generic_name": "naproxen sodium, pseudoephedrine hydrochloride", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aleve-D Sinus and Headache", "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": "20140101", "listing_expiration_date": "20261231"}