Reckitt has announced that the U.S. Food and Drug Administration (FDA) has approved Mucinex 12HR Cold and Fever Multi-Symptom, making it the first Over-the-Counter (OTC) innovation in the cold and flu category to receive FDA approval in 14 years. The approval also marks the first New Drug Application (NDA) approved under the Reckitt name, representing a major regulatory milestone for the consumer health company.

The newly approved medicine was developed following more than a decade of scientific research, product development, clinical evaluation and regulatory collaboration. Designed to reflect evolving consumer preferences for convenient, long-lasting symptom management, the product aims to provide extended relief from multiple cold and flu symptoms through a single formulation.

The approval comes amid a growing burden of seasonal respiratory illnesses in the United States. According to the U.S. Centres for Disease Control and Prevention (CDC), the 2024–25 influenza season resulted in an estimated 51 million illnesses, while the 2025–26 season experienced an early and widespread surge in flu activity. As consumers increasingly rely on OTC medicines as a first line of self-care, demand for safe, effective and longer-lasting treatment options continues to rise.

Mucinex 12HR Cold and Fever Multi-Symptom is the first product in its category to combine guaifenesin, dextromethorphan hydrobromide and naproxen sodium, a Non-Steroidal Anti-Inflammatory Drug (NSAID), in a bilayer tablet. The formulation provides both immediate and extended release of its active ingredients, offering symptom relief that lasts for up to 12 hours—up to three times longer than most conventional cold and flu medicines, according to the company.

Reckitt said the product was specifically developed to address the inflammatory processes that contribute to many common cold and flu symptoms, delivering sustained multi-symptom relief in a single dose.

With the FDA approval, Reckitt is expanding its portfolio of consumer healthcare products while introducing a new treatment option aimed at improving convenience and symptom management for millions of people affected by seasonal cold and flu illnesses.