Who makes Kirkland Signature Arthritis Pain Relief Gel (Diclofenac Sodium Topical Gel 1%), 3 x 5.29 oz?

Drugs@FDA lists abbreviated new drug application ANDA 211253 (diclofenac sodium, topical gel 1%) with sponsor 'PERRIGO PHARMA INTL' (Perrigo Pharma International). Costco's two current 'Arthritis Pain Relief' NDCs, 63981-599 and 63981-799 (different pack sizes), both reference ANDA 211253 in the FDA NDC directory (a delisted third, 63981-870, did too) - the NDC->ANDA->sponsor join that identifies Perrigo as the FDA application holder for those SKUs. The directory separately lists Kirkland diclofenac 1% gel NDCs 63981-112 and 63981-211 under ANDA 208077 (sponsor Amneal; distributed by PL Developments for Costco - see the Amneal-side sources below), still without an end date, so this application covers part of the Kirkland line, not all of it. This is an indirect join (the ANDA holder is FDA's responsible party, not necessarily the physical packer), and the application is a multi-source private-label ANDA also covering Equate, CVS, Walgreens, Member's Mark and other store brands - so the join supports probable, not confirmed.

FDA-filed Structured Product Label for Kirkland Signature Arthritis Pain Relief gel (NDC 63981-599; labeler 'Costco Wholesale Company'). The package display panel reads 'Compare to Voltaren,' 'Diclofenac Sodium Topical Gel, 1% (NSAID),' 'Distributed By Perrigo, Allegan, MI 49010,' and 'Made in Israel' - the on-label link tying the Costco product to Perrigo as distributor-of-record with an Israel manufacturing origin. 'Distributed By' is a distributor-of-record designation, so on its own it supports probable rather than confirmed.

FDA-filed Structured Product Label for the Amneal-application Kirkland gel: labeler 'Costco Wholesale' (DUNS 103391843; note the labeler string differs from the 'Costco Wholesale Company' used on the Perrigo-application SPLs), NDC 63981-112 (package 63981-112-15, 3 x 150 g tubes, marketing start 10/30/2020), Marketing Category ANDA, Application Number ANDA208077. The package label is titled 'KIRKLAND Arthritis Pain Reliever' and its carton text reads 'Distributed by: PL Developments Westbury, NY 11590 U.S.A. For: Costco Wholesale Corporation'. No plant is named; PL Developments is the distributor of record and the application holder (Amneal, per the Drugs@FDA source) is FDA's responsible party, so this chain, like the Perrigo one, supports probable. FDA's NDC directory shows no marketing end date for this NDC (listing valid through 2026-12-31).

The second Amneal-application Kirkland SPL: labeler 'Costco Wholesale', NDC 63981-211 (package 63981-211-15, 3 x 150 g tubes, marketing start 12/31/2022), Marketing Category ANDA, Application Number ANDA208077. Package label 'KIRKLAND Arthritis Pain Reliever Gel'; carton text 'Distributed by: PL Developments Westbury, NY 11590 U.S.A. For: Costco Wholesale Corporation 999 Lake Drive Issaquah, WA 98027 USA' followed by 'Product of India'. Together with the -112 SPL it establishes that Costco's diclofenac gel has run under two FDA applications (Amneal's 208077 via PL Developments, and Perrigo's 211253) - the brand-link naming that makes this chain part of the attribution rather than context. No end date in the NDC directory; whether this version is currently on shelves cannot be settled from FDA data.

FDA's Drugs@FDA database resolves ANDA208077 to sponsor_name 'AMNEAL PHARMS' (Amneal Pharmaceuticals), product DICLOFENAC SODIUM gel, original approval 2016-03-18 (latest supplement 2020-08-13). The application's openFDA index lists brand names 'ARTHRITIS PAIN RELIEVER', 'DICLOFENAC SODIUM' and 'SALONPAS', and its product_ndc roster includes both Kirkland codes, 63981-112 and 63981-211, alongside other store brands - the NDC->ANDA->sponsor join for the PL Developments-distributed Kirkland gel. Indirect on its own (the ANDA holder is FDA's responsible party, not necessarily the plant; the carton says only 'Product of India'), so it supports probable for the Amneal branch, matching the Perrigo branch's grade.

Costco's Business Delivery storefront (costcobusinessdelivery.com) serves the same US catalog data as costco.com and, unlike costco.com, can be fetched and archived. Its page for this item - 'Kirkland Signature Diclofenac Sodium Topical Gel, Arthritis Pain Reliever, 5.29 oz, 3 ct' (item 100414966) - embeds catalog JSON whose manufacturer field reads mfName: "L PERRIGO COMPANY", L. Perrigo Company being Perrigo's principal US operating company (Allegan, MI). Read on August 30, 2026 and verified present in the Wayback snapshot created the same day. An internal catalog field rather than an editorial statement, and such fields can name a supplier-of-record rather than the plant. It corroborates that the currently listed three-tube 5.29 oz (150 g) item sits on the Perrigo chain - Perrigo as Costco's vendor of record, matching the ANDA 211253 branch (sponsor Perrigo Pharma International; carton 'Distributed By Perrigo, Allegan, MI'). Two limits keep it corroboration rather than a resolution of the dual-source question: the listing title uses the 'Arthritis Pain Reliever' wording that the Amneal-application cartons (NDCs 63981-112 / 63981-211, also 3 x 150 g) carry, and the field says nothing about which FDA application the packs on a given shelf are labeled under, so the Amneal branch (ANDA 208077, still listed without an end date) stays in the attribution. Status stays probable: the field is a supplier-of-record naming and neither carton names the plant.