aleve headache pain

Generic: naproxen sodium

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

Drug Facts

Product Profile

Brand Name aleve headache pain
Generic Name naproxen sodium
Labeler bayer healthcare llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0112
Product ID 0280-0112_31baf777-c806-21ea-e063-6394a90abbd8
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020204
Listing Expiration 2026-12-31
Marketing Start 2023-04-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02800112
Hyphenated Format 0280-0112

Supplemental Identifiers

RxCUI
849574 849728
UPC
0025866593527
UNII
9TN87S3A3C

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 headache pain (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number NDA020204 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0280-0112-01) / 175 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0280-0112-02) / 24 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0280-0112-03) / 50 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0280-0112-04) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (4)

0280-0112-01 1 BOTTLE in 1 CARTON (0280-0112-01) / 175 TABLET in 1 BOTTLE 0280-0112-02 1 BOTTLE in 1 CARTON (0280-0112-02) / 24 TABLET in 1 BOTTLE 0280-0112-03 1 BOTTLE in 1 CARTON (0280-0112-03) / 50 TABLET in 1 BOTTLE 0280-0112-04 1 BOTTLE in 1 CARTON (0280-0112-04) / 90 TABLET in 1 BOTTLE

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Aleve Headache Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31baf777-c806-21ea-e063-6394a90abbd8", "openfda": {"upc": ["0025866593527"], "unii": ["9TN87S3A3C"], "rxcui": ["849574", "849728"], "spl_set_id": ["31baf777-c805-21ea-e063-6394a90abbd8"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-0112-01)  / 175 TABLET in 1 BOTTLE", "package_ndc": "0280-0112-01", "marketing_start_date": "20240325"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-0112-02)  / 24 TABLET in 1 BOTTLE", "package_ndc": "0280-0112-02", "marketing_start_date": "20240325"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-0112-03)  / 50 TABLET in 1 BOTTLE", "package_ndc": "0280-0112-03", "marketing_start_date": "20240325"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-0112-04)  / 90 TABLET in 1 BOTTLE", "package_ndc": "0280-0112-04", "marketing_start_date": "20240325"}], "brand_name": "Aleve Headache Pain", "product_id": "0280-0112_31baf777-c806-21ea-e063-6394a90abbd8", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0280-0112", "generic_name": "NAPROXEN SODIUM", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aleve", "brand_name_suffix": "Headache Pain", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "NDA020204", "marketing_category": "NDA", "marketing_start_date": "20230404", "listing_expiration_date": "20261231"}