Who Owns Zyrtec?

Cetirizine, the active ingredient in Zyrtec, was developed by UCB Pharma, a pharmaceutical company based in Brussels, Belgium. Cetirizine is a second-generation histamine-1 receptor antagonist, a class of antihistamines that produce less drowsiness than first-generation antihistamines such as diphenhydramine. UCB conducted the initial research and clinical development of cetirizine in the 1980s and marketed the product in Europe under the Zyrtec brand name.

In February 1995, the FDA informed Pfizer, UCB's US licensee, that Zyrtec was approvable for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic urticaria. The FDA and Pfizer began discussions on final labeling requirements. The FDA approved Zyrtec tablets in December 1995 for adults and children 12 years of age and older (NDA 019835). The product was jointly promoted by UCB Pharma and Pfizer in the United States.

In September 1996, the FDA approved Zyrtec syrup for adults and children 6 to 11 years of age (NDA 020346). In May 1998, the FDA expanded approval to include adults and children 2 to 5 years of age for seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria. In October 2002, the FDA further expanded approval to include adults and children 6 months of age and older for the relief of symptoms associated with these conditions.

Marketing rights for Zyrtec in the United States later transferred from Pfizer to Johnson and Johnson's McNeil Consumer Healthcare division. McNeil managed the brand through a significant transition: the switch from prescription to over-the-counter status. In November 2007, the FDA approved Zyrtec for nonprescription use in adults and children 2 years of age and older for the temporary relief of symptoms due to hay fever or other upper respiratory allergies, including sneezing, runny nose, itchy and watery eyes, and itching of the nose or throat. The FDA also approved Zyrtec for nonprescription treatment of itching due to hives. The OTC switch was a major commercial milestone, as it made Zyrtec available without a prescription and expanded the brand's consumer reach significantly.

The FDA also approved Zyrtec-D, a combination product containing cetirizine hydrochloride and pseudoephedrine hydrochloride, for nonprescription use in November 2007. Zyrtec-D is subject to restrictions under the Combat Methamphetamine Epidemic Act, which limits the purchase quantity of products containing pseudoephedrine and requires record-keeping by retail establishments.

Following the OTC switch, Zyrtec became one of the top-selling allergy medications in the United States. The brand competed against Claritin (loratadine, manufactured by Bayer) and Allegra (fexofenadine, manufactured by Sanofi), both of which had also switched from prescription to OTC status. Zyrtec differentiated itself through marketing that emphasized fast-acting relief and effectiveness for both indoor and outdoor allergies.

In May 2023, Johnson and Johnson completed the spinoff of its Consumer Health segment as Kenvue Inc. Zyrtec transferred to Kenvue's brand portfolio as part of this separation. Kenvue began trading on the New York Stock Exchange under ticker symbol KVUE. Johnson and Johnson sold its remaining stake in Kenvue in August 2023, completing the separation.

In March 2026, Zyrtec announced a multiyear strategic brand partnership with the PGA TOUR, making Zyrtec the first Official Allergy Relief Sponsor of the league. The partnership debuted alongside the brand's new "Yes Season" campaign, which encourages allergy sufferers to maintain their outdoor activities during allergy season. PGA TOUR players Akshay Bhatia and Neal Shipley were named as Player Ambassadors. The four-year agreement includes onsite experiences at five tournaments in high-allergen regions, including The Relief Zone and Pollen PuttPutt activities for fans.

In June and July 2026, the FDA issued approval letters for Zyrtec Allergy and Zyrtec Hives supplements to Kenvue Brands LLC. These approvals covered labeling revisions and new packaging formats for Zyrtec tablets, including 50-count dispensers and 1-count pouches for both healthcare professional samples and retail sale.