Who makes Kirkland Signature LaxaClear (Polyethylene Glycol 3350), 100 Doses?

FDA structured product label for Kirkland Signature LaxaClear, NDC 63981-306, labeler Costco Wholesale Company (103391843), citing application 'ANDA090685'. Establishes the NDC-to-application link; the label lists only Costco as labeler/packager and names no separate manufacturing establishment.

Drugs@FDA application overview for ANDA 090685: 'Abbreviated New Drug Application (ANDA): 090685 Company: PPI-DAC'. PPI-DAC is the application holder of record, i.e. Perrigo Pharma International DAC, an Irish subsidiary of Perrigo Company plc. The NDC-to-application-to-sponsor join is indirect, and the application holder is FDA's responsible party rather than necessarily the plant that fills each package, so on its own this join would cap the attribution at probable; Costco's own catalog manufacturer field naming L. Perrigo Company for the same item (see the Costco Business Delivery source) is the independent corroboration that carries the record to confirmed. Drugs@FDA lists a Manufacturing (CMC) supplement (S-019) approved August 18, 2026; the sponsor is unchanged. A CMC supplement can be a manufacturing-site or process change and its content is not public, so the SPL is due a re-check for any new "Manufactured by" line.

Perrigo's own announcement, dated the ANDA 090685 approval date: Perrigo 'received final approval from the FDA for over-the-counter (OTC) Polyethylene Glycol 3350, Powder for Solution ... marketed under store brand labels and ... comparable to Schering-Plough HealthCare Products' MiraLAX(R).' Corroborates that Perrigo is the store-brand PEG 3350 applicant of record behind this application; it does not by itself name the plant that fills the Kirkland package.

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 LaxaClear, 29.9 oz, 2 Bottles of 50 Doses', item 100296329) 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; here it independently corroborates the FDA route (NDC 63981-306 -> ANDA 090685 -> holder PPI-DAC, Perrigo Pharma International DAC): the retailer names Perrigo's US operating company and the regulator names its Irish application-holding affiliate, two entities of the same group, which meets the rule for confirmed (Costco's manufacturer field plus an independent naming). The application holder remains FDA's responsible party rather than a guaranteed physical packer; the retailer's own field agreeing with it is what closes the attribution.