diclofenac sodium topical

Generic: diclofenac sodium

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium topical
Generic Name diclofenac sodium
Labeler cvs woonsocket prescription center, incorporated
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-804
Product ID 51316-804_caa8dc8f-4b10-4098-957d-c9ab06dfec03
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211253
Listing Expiration 2027-12-31
Marketing Start 2025-05-13

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 51316804
Hyphenated Format 51316-804

Supplemental Identifiers

RxCUI
855633
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 diclofenac sodium topical (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA211253 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51316-804-01) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51316-804-02) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51316-804-03) / 150 g in 1 TUBE
source: ndc

Packages (3)

51316-804-01 1 TUBE in 1 CARTON (51316-804-01) / 100 g in 1 TUBE 51316-804-02 1 TUBE in 1 CARTON (51316-804-02) / 50 g in 1 TUBE 51316-804-03 1 TUBE in 1 CARTON (51316-804-03) / 150 g in 1 TUBE

Ingredients (1)

diclofenac sodium (10 mg/g)

Linked Drug Pages (1)

DICLOFENAC SODIUM TOPICAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "caa8dc8f-4b10-4098-957d-c9ab06dfec03", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["181e32ab-5ec0-4be4-bad0-b6bbafc08f85"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51316-804-01)  / 100 g in 1 TUBE", "package_ndc": "51316-804-01", "marketing_start_date": "20251014"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51316-804-02)  / 50 g in 1 TUBE", "package_ndc": "51316-804-02", "marketing_start_date": "20250908"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51316-804-03)  / 150 g in 1 TUBE", "package_ndc": "51316-804-03", "marketing_start_date": "20250513"}], "brand_name": "DICLOFENAC SODIUM TOPICAL", "product_id": "51316-804_caa8dc8f-4b10-4098-957d-c9ab06dfec03", "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": "51316-804", "generic_name": "DICLOFENAC SODIUM", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DICLOFENAC SODIUM TOPICAL", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA211253", "marketing_category": "ANDA", "marketing_start_date": "20250513", "listing_expiration_date": "20271231"}