aleve arthritis pain gel

Generic: diclofenac sodium

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

Drug Facts

Product Profile

Brand Name aleve arthritis pain gel
Generic Name diclofenac sodium
Labeler bayer healthcare llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 1 mg/g

Manufacturer
Bayer HealthCare LLC

Identifiers & Regulatory

Product NDC 0280-0039
Product ID 0280-0039_452615d3-7d62-4fa6-e063-6394a90a5dfd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211253
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02800039
Hyphenated Format 0280-0039

Supplemental Identifiers

RxCUI
855633 2550740
UPC
0025866593619
UNII
QTG126297Q

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 arthritis pain gel (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA211253 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0280-0039-01) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0280-0039-02) / 50 g in 1 TUBE
source: ndc

Packages (2)

0280-0039-01 1 TUBE in 1 CARTON (0280-0039-01) / 100 g in 1 TUBE 0280-0039-02 1 TUBE in 1 CARTON (0280-0039-02) / 50 g in 1 TUBE

Ingredients (1)

diclofenac sodium (1 mg/g)

Linked Drug Pages (1)

Aleve Arthritis Pain Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "452615d3-7d62-4fa6-e063-6394a90a5dfd", "openfda": {"upc": ["0025866593619"], "unii": ["QTG126297Q"], "rxcui": ["855633", "2550740"], "spl_set_id": ["bad675d1-1204-0136-e053-2995a90a994e"], "manufacturer_name": ["Bayer HealthCare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0280-0039-01)  / 100 g in 1 TUBE", "package_ndc": "0280-0039-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0280-0039-02)  / 50 g in 1 TUBE", "package_ndc": "0280-0039-02", "marketing_start_date": "20210601"}], "brand_name": "Aleve Arthritis Pain Gel", "product_id": "0280-0039_452615d3-7d62-4fa6-e063-6394a90a5dfd", "dosage_form": "GEL", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0280-0039", "generic_name": "Diclofenac Sodium", "labeler_name": "Bayer HealthCare LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aleve Arthritis Pain Gel", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "1 mg/g"}], "application_number": "ANDA211253", "marketing_category": "ANDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}