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Kirkland Signature Nicotine Lozenges (Quit 2 & Quit 4, 2 mg / 4 mg) Health Confirmed
Kirkland Signature · Health

Who makes Kirkland Signature Nicotine Lozenges (Quit 2 & Quit 4, 2 mg / 4 mg)?

Manufactured by
Perrigo
Citable fact

As of August 30, 2026, the manufacturer of Kirkland Signature Nicotine Lozenges (Quit 2 & Quit 4, 2 mg / 4 mg) is Perrigo, per plant / registration code evidence.

Verified August 30, 2026
The common claim vs. the evidence

The common claim

What most answers say — and what the evidence supports

Store-brand roundups and AI answer boxes generally credit Perrigo — the largest US maker of private-label OTC drugs — and FDA drug records line up with that across both applications behind the line. The Quit 2 (2 mg) and Quit 4 (4 mg) lozenges (NDC 63981-344 / 63981-873) are marketed under ANDA 077007, whose Drugs@FDA sponsor is a Perrigo R&D entity; the cherry-flavor Kirkland Signature Nicotine lozenges (NDC 63981-124 / 63981-190) are marketed under ANDA 090711, whose sponsor is Perrigo Pharma International DAC, a Perrigo affiliate. Both cartons reproduced on the FDA label carry a 'Packaged By Perrigo, Allegan, MI' line, a 2014 FDA recall documents Perrigo's Allegan plant handling private-label nicotine polacrilex lozenges, and Costco's own product listing for the 2 mg lozenges carries "L Perrigo Company" in its manufacturer field. The application joins are indirect on their own, but both cartons reproduced on the FDA label name Perrigo as the physical packager ('Packaged By Perrigo, Allegan, MI'), which is what makes this a confirmed attribution.

The receipts

Evidence & sources

Every source is graded on the six-tier rubric and archived, so the citation holds even if the original moves or paywalls. The tier badge grades the source; the status grades our confidence in the maker.

Tier 3 DailyMed (U.S. National Library of Medicine) KIRKLAND SIGNATURE QUIT 2 - nicotine polacrilex lozenge (DailyMed SPL) Published · accessed August 1, 2026
DailyMed's FDA-sourced label 'KIRKLAND SIGNATURE QUIT 2- nicotine polacrilex lozenge' names Costco Wholesale Company as the labeler/packager (DUNS 103391843), lists NDC 63981-344 (nicotine polacrilex 2 mg lozenge), and gives Marketing Category 'Abbreviated New Drug Application' with Application Number ANDA077007. The 4 mg sibling, Kirkland Signature Quit 4 (NDC 63981-873, setid cd1c3493-242c-4981-8561-ebbea938628f), sits under the same ANDA. Beyond the Costco labeler line, the carton text reproduced on the SPL reads 'Packaged By Perrigo® Allegan, MI 49010' and 'COMPARE TO NICORETTE® LOZENGE' — an on-carton naming of Perrigo as physical packager. The deterministic maker link runs through the ANDA number (resolved to a Perrigo entity in the Drugs@FDA source below), corroborated by this Perrigo carton statement.
Tier 3 U.S. Food & Drug Administration (openFDA Drugs@FDA) Drugs@FDA record for ANDA 077007 (nicotine polacrilex lozenge 2 mg / 4 mg), sponsor Perrigo R&D Published · accessed August 1, 2026
Drugs@FDA resolves ANDA077007 — the application behind Kirkland Signature Quit 2 (NDC 63981-344) and Quit 4 (NDC 63981-873) nicotine polacrilex lozenges — to sponsor 'PERRIGO R AND D', products NICOTINE POLACRILEX TROCHE/LOZENGE, 2 mg and 4 mg base. Perrigo is the largest US maker of private-label OTC drugs and has publicly announced store-brand nicotine-lozenge launches (e.g. its 2013-01-22 release 'Perrigo Launches Store Brand Version Of Nicorette® Mini Nicotine Lozenges'). Independent tier-2 corroboration that Perrigo's Allegan plant turns out private-label nicotine polacrilex lozenges: FDA recall D-1558-2014 (Class III, 2014), recalling firm Perrigo Holland Inc, covers 'Nicotine Polacrilex Lozenge, 2 mg Mint Mini... Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010', labeled for CareOne, CVS, equate, Kroger, Rite Aid, TopCare, Walgreens and Target — a sibling private-label lozenge, not the Kirkland SKU itself. The ANDA join alone would cap this at probable (openFDA's NDC manufacturer_name only echoes the Costco labeler, and an ANDA applicant is not guaranteed to be the physical packer); the on-carton 'Packaged By Perrigo, Allegan, MI' line on the SPL is what carries the record to confirmed (ruling of August 30, 2026).
Tier 3 DailyMed (U.S. National Library of Medicine) KIRKLAND SIGNATURE NICOTINE - nicotine lozenge (DailyMed SPL) Published · accessed August 1, 2026
DailyMed's FDA-sourced label 'KIRKLAND SIGNATURE NICOTINE- nicotine lozenge' names Costco Wholesale Company as labeler/packager (DUNS 103391843), lists NDC 63981-124 (nicotine polacrilex 2 mg lozenge), and gives Marketing Category 'Abbreviated New Drug Application' with Application Number ANDA090711 — a second, distinct application from the Quit 2/Quit 4 ANDA. The 4 mg sibling (NDC 63981-190, setid 0888a974-a8ba-4cb3-996f-c8abfcb90a6f) sits under the same ANDA. The carton text on the SPL again reads 'Packaged By Perrigo® Allegan, MI 49010' and 'COMPARE TO NICORETTE® LOZENGE'. The maker link runs through the ANDA number, resolved in the Drugs@FDA source below.
Tier 3 U.S. Food & Drug Administration (openFDA Drugs@FDA) Drugs@FDA record for ANDA 090711 (nicotine polacrilex lozenge 2 mg / 4 mg), sponsor PPI-DAC (Perrigo Pharma International DAC) Published · accessed August 1, 2026
Drugs@FDA resolves ANDA090711 — the application behind the cherry-flavor Kirkland Signature Nicotine lozenges (the SPL's principal display panel reads CHERRY; sold by Costco as 'Quit 2mg or 4mg, Cherry Lozenges, 270 Pieces') (NDC 63981-124 / 63981-190) — to sponsor 'PPI-DAC', i.e. Perrigo Pharma International Designated Activity Company, a Dublin-registered Perrigo affiliate (Perrigo's corporate parent is domiciled in Ireland). openFDA's aggregated manufacturer_name list for this application includes 'L. Perrigo Company' alongside the many private-label labelers (Costco, Walgreen, Wal-Mart, Kroger, Rite Aid, CVS, Target, Publix, H-E-B, Meijer, Amazon, Topco). Both Kirkland nicotine-lozenge applications therefore resolve through the NDC→ANDA→sponsor join to Perrigo entities — a cleaner single-source picture than Kirkland's ibuprofen line, which traces to several different applicants. On its own this join is indirect (the ANDA holder is FDA's responsible party, not necessarily the physical packer); the confirmed grade rests on the carton's 'Packaged By Perrigo, Allegan, MI' statement reproduced on the SPL.
Tier 4 Costco Wholesale Kirkland Signature Quit Lozenges, 2 mg, 270 Pieces, 10 ct (Costco Business Delivery product-listing data) Published · accessed August 30, 2026
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 Quit Lozenges, 2 mg, 270 Pieces, 10 ct' (item 100193207; the listing describes the mint-flavored 2 mg lozenge, i.e. Quit 2 under ANDA 077007) - 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. Corroboration from a third, independent route: the record is already confirmed on the on-carton 'Packaged By Perrigo, Allegan, MI' line reproduced on the FDA label, with the ANDA joins to Perrigo entities behind it (DECISIONS 2026-08-30); the retailer's own manufacturer field naming the same company is consistent with both and would itself satisfy the mfName-plus-independent-naming rule. It does not change the grade or the tier.
People also ask

Frequently asked

Who makes Kirkland Signature nicotine lozenges (Quit 2 and Quit 4)?
FDA drug records point to Perrigo, the largest US private-label OTC drugmaker. Costco markets the Quit 2 (2 mg) and Quit 4 (4 mg) lozenges under ANDA 077007 and the cherry-flavor Kirkland Signature Nicotine lozenges under ANDA 090711, and FDA's Drugs@FDA database lists Perrigo entities — a Perrigo R&D company and Perrigo Pharma International DAC — as the holders of both. Each carton also carries a 'Packaged By Perrigo, Allegan, MI' line. The carton's 'Packaged By Perrigo, Allegan, MI' statement, reproduced on the FDA label, names Perrigo as the physical packager, and FDA's Drugs@FDA database lists Perrigo entities as holders of both applications.
Are Kirkland nicotine lozenges the same as Nicorette?
They share the same active ingredient and strengths — nicotine polacrilex 2 mg and 4 mg — and meet the same FDA generic standard, and the Kirkland cartons themselves read 'Compare to Nicorette.' But they are different products: Nicorette is a Haleon brand, while the Kirkland lozenges are Costco's store-brand version, marketed under Perrigo-held generic-drug applications. Same drug, different label — and not necessarily a different maker: FDA's NDC directory lists Haleon's own Nicorette lozenges NDC 0135-0635 / 0135-0636 under ANDA 077007, the same Perrigo application as Kirkland Quit 2 and Quit 4. Usually at a fraction of the per-lozenge price.
Are Kirkland Quit 2 / Quit 4 and the cherry Kirkland Signature Nicotine lozenges from the same company?
FDA records tie both to Perrigo, though under two different generic-drug applications. The Quit 2 / Quit 4 lozenges (NDC 63981-344 / 63981-873) trace to ANDA 077007, whose sponsor is a Perrigo R&D entity, and the cherry-flavor Kirkland Signature Nicotine lozenges (NDC 63981-124 / 63981-190) to ANDA 090711, whose sponsor is Perrigo Pharma International DAC. Both cartons carry the same 'Packaged By Perrigo, Allegan, MI' statement, so the whole Kirkland nicotine-lozenge line points to Perrigo — a more single-sourced picture than some Costco OTC products, such as its ibuprofen, which trace to several different contract manufacturers.
Prefer the name brand? Nicorette (nicotine polacrilex lozenge) The closest name-brand equivalent to this Kirkland Signature product.

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