topcare arthritis pain reliever

Generic: diclofenac sodium

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare arthritis pain reliever
Generic Name diclofenac sodium
Labeler topco associates llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-804
Product ID 76162-804_d83fd3e5-05a0-406e-813d-71b5dfd05caf
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211253
Listing Expiration 2026-12-31
Marketing Start 2025-09-05

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 76162804
Hyphenated Format 76162-804

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 topcare arthritis pain reliever (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 (76162-804-01) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (76162-804-02) / 50 g in 1 TUBE
source: ndc

Packages (2)

76162-804-01 1 TUBE in 1 CARTON (76162-804-01) / 100 g in 1 TUBE 76162-804-02 1 TUBE in 1 CARTON (76162-804-02) / 50 g in 1 TUBE

Ingredients (1)

diclofenac sodium (10 mg/g)

Linked Drug Pages (1)

TOPCARE ARTHRITIS PAIN RELIEVER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d83fd3e5-05a0-406e-813d-71b5dfd05caf", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["1d6c4c38-3739-4d58-9811-bac09fcbfadb"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (76162-804-01)  / 100 g in 1 TUBE", "package_ndc": "76162-804-01", "marketing_start_date": "20251024"}, {"sample": false, "description": "1 TUBE in 1 CARTON (76162-804-02)  / 50 g in 1 TUBE", "package_ndc": "76162-804-02", "marketing_start_date": "20250905"}], "brand_name": "TOPCARE ARTHRITIS PAIN RELIEVER", "product_id": "76162-804_d83fd3e5-05a0-406e-813d-71b5dfd05caf", "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": "76162-804", "generic_name": "DICLOFENAC SODIUM", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TOPCARE ARTHRITIS PAIN RELIEVER", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA211253", "marketing_category": "ANDA", "marketing_start_date": "20250905", "listing_expiration_date": "20261231"}