Home NDC 63981-799 kirkland signature arthritis pain relief
Product NDC 63981-799
11-digit product format 639810799
Labeler code 63981
Product ID 63981-799_7c10348c-faee-4c1e-861a-fc6e83d8cd66
Type HUMAN OTC DRUG
Nonproprietary name DICLOFENAC SODIUM
Dosage form GEL
Route TOPICAL
Labeler Costco Wholesale Company
Application ANDA211253
Marketing category ANDA
Marketing start 2025-06-10
Substance DICLOFENAC SODIUM
Active strength 10 mg/g
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211253-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 2 · 40 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base kirkland signature arthritis pain relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QTG126297Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855633 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63981-799-03 kirkland signature arthritis pain relief 150 g in 1 TUBE GEL 150 2 63981-799-05 kirkland signature arthritis pain relief 3 in 1 CARTON GEL 3 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63981-799-03 63981079903 150 g in 1 TUBE 150 g Historical 63981-799-05 63981079905 3 TUBE in 1 CARTON (63981-799-05) / 150 g in 1 TUBE (63981-799-03) 3 tube 2025-06-10 No No Current