Reckitt Announces U.S. FDA Approval of Mucinex 12HR Cold & Fever Multi-Symptom, the First OTC Innovation in the Cold & Flu Category in 14 Years

The consumer health organization Reckitt has received U.S. FDA approval for Mucinex 12HR Cold & Fever Multi-Symptom, marking the first over-the-counter (OTC) New Drug Application (NDA) innovation in the cold and flu category in 14 years.

Reckitt announced a milestone for the cold and flu category and the organization: Mucinex 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter (OTC) innovation in the cold and flu category in 14 years, and the first New Drug Application (NDA) in the Reckitt name to receive FDA approval. Industrialized to align with the way patients choose to treat cold and flu symptoms, this success reflects more than an era of Reckitt’s scientific research, advancement, clinical evaluation, and regulatory partnership.

The approval comes at a time when cold and flu place progressively important challenges on Americans, driving millions of illnesses, medical care visits, and missed days of work and school each year. According to the Centers for Disease Control and Prevention (CDC), the 2024-25 flu season resulted in an estimated 51 million illnesses, while the 2025-26 season saw a spike in flu cases in the country that coincided with an earlier flu season. As consumers continue to rely on OTC medicines as a first line of self-care, increasing access to novel innovations that offer safe, efficient, and convenient symptom relief is more important than ever.

“This milestone reinforces Reckitt’s commitment to delivering trusted, science-backed solutions that meet everyday health needs and truly fit how Americans live. 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.” Said by Jérôme Lemaire, President, Reckitt North America.

Cold and flu symptoms are significantly driven by the body’s inflammatory response to infection. Identifying the role that inflammatory processes play in major cold and flu indications, Mucinex 12HR Cold & Fever Multi-Symptom was industrialized to offer long-lasting multi-symptom release. As the first product in its category to integrate guaifenesin, dextromethorphan HBr, and naproxen sodium, an NSAID, in a bilayer tablet, it delivers rapid and protracted release of active ingredients, offering symptom relief that lasts up to three times longer than most cold and flu therapeutics.

According to Towards Healthcare, the North America life science market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 44.49 billion in 2026 to approximately USD 124.18 billion by 2035, expanding at a CAGR of 12.08%.The life sciences industry continues to push the limitations of healthcare innovation, such as cell and gene therapy, which promises targeted medicine for specific diseases. These advanced therapies, while transformative, present challenges in terms of production cost and temperature-sensitive logistics. Life science offers significant benefits by enhancing human health via well-developed healthcare treatments, improving food security through agricultural innovations, and protecting ecosystems via environmental conservation. It drives financial growth and high-value career opportunities in pharmaceuticals, biotechnology, and research.

About Reckitt

This company makes the products consumers trust to care for the ones they love. Reckitt is home to some of the global best-loved consumer health and hygiene brands, involving Dettol, Durex, Finish, Gaviscon, Harpic, Lysol, Mucinex, Nurofen, Strepsils, Vanish and Veet. Customers are at the heart of everything do. By making innovative, science-backed services, this organization supports patients each day to live healthier lives. 

Reckitt is committed to protect, heal and nurture in the pursuit of a cleaner, healthier biosphere. This commitment goes beyond the products the company makes. Through actions, the company expands access to medical care, education and economic opportunities. This company support the planet by lowering waste, conserving resources and increasing sustainable innovation. 

This company believes good health starts at home. With each action taken, we strive to make consumers’ lives easier, cleaner and healthier, to strengthen communities and to create a more maintainable future. 

A recent report by Towards Healthcare highlights that the North America life science market is growing as life sciences lend significant insights into disease technology, and enable the advancement of novel therapeutics and innovative healthcare devices, thereby directly enhancing human health. The life sciences allow an understanding of the environment and the other living species with whom consumers share the earth; this knowledge guides conservation efforts and literally support to save shared planet. The life sciences sector consists of companies operating in the fields of pharmaceuticals, biotechnology healthcare tools, biomedical technologies, nutraceuticals, cosmeceuticals, food processing, and others that intend their efforts to create products to enhance the lives of organisms.