Reckitt Secures FDA Approval for First New OTC Cold Medicine in 14 Years

The medication introduces a patented bilayer tablet designed to treat fever, cough, chest congestion, and body pain for a full 12-hour period. By combining guaifenesin, dextromethorphan HBr, and naproxen sodium, the drug addresses a long-standing demand for longer-lasting symptom management. Clinical development for the product spanned more than ten years, aimed at curbing the rising burden of seasonal illnesses that frequently result in missed work and school days across the United States.

Jérôme Lemaire, President of Reckitt North America, noted that the product is intended to ease the care burden on families by reducing the frequency of dosing compared to standard four-hour alternatives. The release is currently rolling out to retailers nationwide as the company looks to modernize its respiratory portfolio. Angela Naef, Chief R&D Officer at Reckitt, stated that the formulation is the direct result of extensive research into how inflammatory responses drive patient discomfort during infections.