Reckitt wins FDA approval for new Mucinex Cold & Flu OTC

NUTLEY, N.J. – Reckitt has achieved a major milestone for both the company and the cold and flu category. Its Mucinex 12HR Cold & Fever Multi-Symptom is the first FDA-approved over-the-counter (OTC) cold and flu innovation in 14 years and marks the first New Drug Application (NDA) approved by the FDA under the Reckitt name. Developed to align with the way consumers choose to manage cold and flu symptoms, this achievement reflects more than a decade of Reckitt’s scientific research, development, clinical evaluation and regulatory collaboration.

The approval comes as cold and flu illnesses continue to take a growing toll on Americans, leading to millions of illnesses, healthcare visits, and missed work and school days each year. The Centers for Disease Control and Prevention (CDC) estimates that the 2024-25 flu season caused 51 million illnesses, while the 2025-26 season brought an early and widespread surge in flu activity nationwide. With consumers increasingly turning to over-the-counter medicines as a first line of self-care, expanding access to innovative products that deliver safe, effective, and convenient symptom relief has never been more critical.

“This milestone reinforces Reckitt’s commitment to delivering trusted, science-backed solutions that meet everyday health needs and truly fit how Americans live,” said Jérôme Lemaire, president, Reckitt North America. “By advancing the cold and flu category with longer-lasting, 12-hour symptom relief, we are not just expanding consumer choice and access, we are easing the care burden on families and empowering people to stay focused on their daily lives.”

Cold and flu symptoms are largely driven by the body’s inflammatory response to infection.³ Recognizing the role that inflammatory processes play in many cold and flu symptoms, Mucinex 12HR Cold & Fever Multi-Symptom was developed to provide long-lasting multi-symptom relief. As the first product in its category to combine guaifenesin, dextromethorphan HBr, and naproxen sodium—an NSAID (non-steroidal anti-inflammatory drug)—in a bilayer tablet, it delivers immediate and extended release of active ingredients providing symptom relief that lasts up to three times longer than most cold and flu medications.**

“True innovation starts with understanding consumer needs and applying science to solve them,” said Angela Naef, Chief R&D Officer, Reckitt. “This approval is the culmination of more than a decade of research and development to create a first-of-its-kind formulation that delivers long-lasting relief from multiple cold and flu symptoms.”