Who makes Kirkland Signature AllerClear-D (Loratadine + Pseudoephedrine, 12 Hr & 24 Hr)?
Probable Strong but indirect evidence
Evidence points to
Perrigo and Sun Pharmaceutical Industries
Citable fact
As of August 30, 2026, evidence points to Perrigo and Sun Pharmaceutical Industries as the manufacturer of Kirkland Signature AllerClear-D (Loratadine + Pseudoephedrine, 12 Hr & 24 Hr), but no tier 1–3 source names the link directly.
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 retail listings generally credit Perrigo - the largest US maker of private-label OTC drugs - for the whole AllerClear-D line and note it works like Claritin-D. FDA drug records show the line is actually split across three separate abbreviated new drug applications with two different sponsors. Two of them - the 12-hour formula (loratadine 5 mg / pseudoephedrine 120 mg, NDC 63981-723, ANDA 076050) and one 24-hour formula (loratadine 10 mg / pseudoephedrine 240 mg, NDC 63981-138, ANDA 075989) - list Perrigo as the Drugs@FDA sponsor. The other 24-hour formula (NDC 63981-724, ANDA 076557) lists Sun Pharmaceutical Industries, and a 2021 FDA recall of that version (D-0069-2022) named its maker in the notice as "Ohm Laboratories Inc.," Sun Pharma's US subsidiary. Because Costco distributes under its own label and the FDA application holder is not always the physical packer, the evidence points to Perrigo and Sun Pharmaceutical rather than proving a single maker - and shows Costco sourcing even one product line from more than one manufacturer.
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's FDA-sourced label for the 12-hour AllerClear-D is titled "KIRKLAND SIGNATURE ALLERCLEAR D 12 HR- loratadine, pseudoephedrine sulfate tablet, film coated, extended release", names Costco Wholesale Company as the labeler, lists NDC 63981-723, active ingredients loratadine 5 mg + pseudoephedrine sulfate 120 mg, and in Marketing Information gives Marketing Category "Abbreviated New Drug Application" with Application Number ANDA076050. No establishment other than Costco appears on the SPL, so the deterministic link runs through the ANDA number; the sibling Drugs@FDA source resolves ANDA076050 to Perrigo.
Tier 3
DailyMed's FDA-sourced label for one 24-hour AllerClear-D is titled "KIRKLAND SIGNATURE ALLERCLEAR D 24 HR- loratadine, pseudoephedrine sulfate tablet, extended release", names Costco Wholesale Company as the labeler, lists NDC 63981-138, active ingredients loratadine 10 mg + pseudoephedrine sulfate 240 mg, and gives Marketing Category "Abbreviated New Drug Application" with Application Number ANDA075989. The Drugs@FDA source resolves ANDA075989 to Perrigo.
Tier 3
DailyMed's FDA-sourced label for the other 24-hour AllerClear-D is titled "KIRKLAND SIGNATURE ALLERCLEAR D 24 HR EXTENDED RELEASE- loratadine and pseudoephedrine sulfate tablet, extended release", labeler Costco Wholesale Company, NDC 63981-724, active ingredients loratadine 10 mg + pseudoephedrine sulfate 240 mg, Marketing Category "Abbreviated New Drug Application" with Application Number ANDA076557. The Drugs@FDA source resolves ANDA076557 to Sun Pharmaceutical Industries - a different sponsor than the other two AllerClear-D NDCs, which is the multi-sourcing story. Unlike the two Perrigo-application SPLs, this label also carries an on-label maker line: "Manufactured by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902 For Costco Wholesale Corporation" - the same Ohm naming the 2021 recall reproduces.
Tier 3
FDA's Drugs@FDA database resolves ANDA076050 - the application under which Costco markets AllerClear-D 12 Hr (NDC 63981-723, loratadine 5 mg + pseudoephedrine sulfate 120 mg, extended-release tablet, over-the-counter) - to sponsor_name PERRIGO PHARMA INTL. Graded probable, not confirmed: the ANDA applicant is FDA's responsible party but is not always the physical packer, and this NDC-to-ANDA-to-sponsor chain is a two-table join rather than an on-label "manufactured by" line.
Tier 3
FDA's Drugs@FDA database resolves ANDA075989 - the application under which Costco markets one AllerClear-D 24 Hr (NDC 63981-138, loratadine 10 mg + pseudoephedrine sulfate 240 mg, extended-release tablet, over-the-counter) - to sponsor_name PERRIGO PHARMA INTL, the same Perrigo entity behind the 12-hour formula. Indirect join, so probable rather than confirmed.
Tier 3
FDA's Drugs@FDA database resolves ANDA076557 - the application under which Costco markets the other AllerClear-D 24 Hr (NDC 63981-724, loratadine 10 mg + pseudoephedrine sulfate 240 mg) - to sponsor_name SUN PHARM INDS LTD (Sun Pharmaceutical Industries), a different sponsor than the two Perrigo NDCs. This branch is independently corroborated at a stronger tier: FDA enforcement recall D-0069-2022 (Class III, initiated 2021-10-12, terminated), recalling firm SUN PHARMACEUTICAL INDUSTRIES INC, describes the product as "AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15" (reason: Failed Moisture Limits). Ohm Laboratories is Sun Pharma's US manufacturing subsidiary, so the recall names the physical maker of this NDC directly - a tier-2 naming folded here because it fixes only one branch of a multi-sourced line, not the line's single headline maker. Recall record archived: https://web.archive.org/web/20260801164152/https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0069-2022%22&limit=1
People also ask
Frequently asked
Who makes Kirkland Signature AllerClear-D for Costco?
FDA drug records tie the AllerClear-D line to two makers. Costco markets it under three separate abbreviated new drug applications: Perrigo is the Drugs@FDA sponsor for the 12-hour formula (ANDA 076050) and one 24-hour formula (ANDA 075989), while Sun Pharmaceutical Industries is the sponsor for the other 24-hour formula (ANDA 076557). A 2021 FDA recall of that Sun Pharmaceutical version named "Ohm Laboratories Inc." - Sun Pharma's US subsidiary - as its manufacturer. Because Costco distributes under its own label and the application holder is not always the physical packer, the evidence points to Perrigo and Sun Pharmaceutical rather than confirming one single maker.
How is Kirkland AllerClear-D different from regular AllerClear?
Regular AllerClear is plain loratadine (10 mg) - a one-ingredient antihistamine comparable to Claritin, sold on the open shelf. AllerClear-D adds the decongestant pseudoephedrine, which is why it sits behind the pharmacy counter and requires photo ID under the federal Combat Methamphetamine Epidemic Act. It comes in a 12-hour version (loratadine 5 mg / pseudoephedrine 120 mg) and a 24-hour version (loratadine 10 mg / pseudoephedrine 240 mg), mirroring Claritin-D. The plain loratadine tablets are marketed under a Perrigo-held application (ANDA 076301); the D line spans three different applications, two of them tied to Perrigo and one to Sun Pharmaceutical.
Is Kirkland AllerClear-D the same as Claritin-D?
They share the same two active ingredients - loratadine and pseudoephedrine sulfate, at matching strengths - and meet the same FDA generic standard, which is why AllerClear-D works like Claritin-D. But they are different products: Claritin-D is a Bayer product, while AllerClear-D is Costco's store-brand version, marketed under FDA applications tied to Perrigo and Sun Pharmaceutical. Same drugs, different makers and label.
Was Kirkland AllerClear-D ever recalled?
Yes - a limited action. In October 2021, Sun Pharmaceutical Industries voluntarily recalled its AllerClear-D 24-hour version (NDC 63981-724) for failing moisture-limit specifications (FDA recall D-0069-2022, Class III). The recall notice identified the physical maker as "Ohm Laboratories Inc." of North Brunswick, New Jersey, a Sun Pharma subsidiary. It was a low-risk (Class III) recall and has since been terminated; the Perrigo-sponsored 12-hour and 24-hour versions were not part of it.
Prefer the name brand? Claritin-D (loratadine + pseudoephedrine) The closest name-brand equivalent to this Kirkland Signature product.
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