Who makes Kirkland Signature Aller-Tec (Cetirizine HCl 10 mg), 365 Tablets?

DailyMed's FDA-sourced Structured Product Label is titled "KIRKLAND SIGNATURE ALLER TEC ALLERGY- cetirizine hydrochloride tablet, film coated", names Costco Wholesale Company as the labeler, lists NDC 63981-458 and active ingredient cetirizine HCl 10 mg, and in Marketing Information gives Marketing Category "ANDA" with Application Number ANDA078336. No establishment other than Costco appears on the SPL, so the deterministic maker link runs through the ANDA number (resolved to Perrigo in the sibling Drugs@FDA source) rather than an on-label "manufactured by" line. This is the brand-to-ANDA anchor for the flagship 365-count Aller-Tec tablet (Costco's cetirizine generic of Zyrtec).

FDA's Drugs@FDA database resolves ANDA078336 - the application under which Costco markets the plain Aller-Tec cetirizine HCl 10 mg tablet (NDC 63981-458) - to sponsor/applicant "PERRIGO R AND D". The application's openFDA index carries brand name "KIRKLAND SIGNATURE ALLER TEC ALLERGY" and NDC 63981-458 alongside dozens of other retailers' store brands sharing the same ANDA. Perrigo is the largest US maker of private-label OTC drugs. On its own this is an indirect two-table NDC-to-ANDA-to-sponsor join (the ANDA applicant is FDA's responsible party but not always the physical packer); it is corroborated by Costco's own catalog manufacturer field (next source), which is what carries the record to confirmed (DECISIONS 2026-08-30). Independent corroboration that Perrigo runs this exact cetirizine line: FDA recall D-0525-2016 (Class III, 2015) covered "Cetirizine HCl 10 mg Tablet, 14 count blister packs" distributed by Perrigo (Allegan, MI) under GoodSense and roughly twenty retailer store brands, each carrying the shared "-458" product-code segment (Kroger 30142-458, HEB 37808-458, Safeway 21130-458, CVS 59779-458) - the same segment as Costco's 63981-458 - though that recall did not name Kirkland itself.

Costco's own product page for the flagship Aller-Tec 365-tablet item (11312465) embeds catalog JSON whose manufacturer field reads mfName: "L PERRIGO COMPANY" - L. Perrigo Company being Perrigo's principal US operating company (Allegan, MI). Read from the 2026-03-05 Wayback snapshot (costco.com blocks automated fetch; the snapshot was verified to contain the field). An internal catalog field rather than an editorial statement, and such fields can name a supplier-of-record; here it independently corroborates the FDA ANDA route, both naming Perrigo, which satisfies the mfName-plus-independent-naming rule for confirmed (DECISIONS 2026-08-30).

Resolves ANDA210719 - the application behind Kirkland Signature Aller-Tec D (cetirizine HCl 5 mg / pseudoephedrine HCl 120 mg extended-release tablets, NDC 63981-147) - to sponsor "PPI-DAC", i.e. Perrigo Pharma International Designated Activity Company, Perrigo's Ireland-domiciled entity (Perrigo Company plc is headquartered in Dublin; "DAC" is the Irish designated-activity-company form). The application's openFDA index carries brand name "KIRKLAND SIGNATURE ALLER TEC D" and NDC 63981-147, and its labeler roster includes "L. Perrigo Company" - so the cetirizine-D combo traces to the same corporate parent (Perrigo) as the plain tablet, not to a separate maker. Indirect two-table join; corroborating. Unlike the loratadine sibling AllerClear-D (whose combo was recalled as an Ohm/Sun lot), the Aller-Tec D application stays entirely within Perrigo.

Resolves ANDA204226 - the application behind Kirkland Signature Children's Aller-Tec (cetirizine HCl 5 mg/5 mL oral solution, NDC 63981-475) - to sponsor "PERRIGO R AND D". openFDA lists brand "KIRKLAND SIGNATURE CHILDRENS ALLER TEC" and NDC 63981-475 under this application. Same Perrigo sponsor as the adult tablet (ANDA078336); indirect two-table join, corroborating.