Nutley, New Jersey, USA, August 5, 2026
Reckitt has received U.S. Food and Drug Administration (FDA) approval for Mucinex® 12HR Cold & Fever Multi-Symptom, marking the first over-the-counter (OTC) innovation in the cold and flu category in 14 years and the first New Drug Application (NDA) approved under the Reckitt name. The newly approved medicine is the first and only FDA-approved OTC treatment that provides up to 12 hours of relief from fever, cough, chest congestion, and body pain in a single dose, addressing one of the most significant unmet needs in consumer healthcare. Developed through more than a decade of scientific research, formulation development, clinical evaluation, and regulatory collaboration, the product expands the Mucinex portfolio while reinforcing Reckitt’s commitment to advancing science-backed innovations for respiratory health. The approval arrives as seasonal influenza and common cold infections continue to place a significant healthcare burden on millions of people, highlighting the growing importance of long-lasting and convenient self-care treatment options.
FDA Approves First Major OTC Cold and Flu Innovation in 14 Years
The approval of Mucinex 12HR Cold & Fever Multi-Symptom represents a significant advancement in the OTC pharmaceutical market, introducing the first major innovation in the cold and flu category since 2012. The medicine combines guaifenesin, dextromethorphan hydrobromide, and naproxen sodium into a unique patented bilayer tablet that delivers both immediate and extended-release therapeutic effects. This innovative formulation enables the medicine to relieve cough, chest congestion, fever, and body aches for up to 12 hours, reducing the need for frequent dosing compared with traditional four-hour cold medicines. According to Reckitt, the product was specifically designed to align with how consumers prefer to manage respiratory illnesses by providing convenient, long-lasting symptom control in a single dose. The FDA approval also represents the fourth regulatory approval for the Mucinex family of products, further strengthening its position in the consumer healthcare market while demonstrating the agency’s confidence in the product’s safety, quality, and effectiveness.
Innovative Multi-Ingredient Formulation Targets Long-Lasting Relief
Mucinex 12HR Cold & Fever Multi-Symptom utilizes an advanced extended-release bilayer tablet technology that combines three active pharmaceutical ingredients with complementary mechanisms of action. Guaifenesin works as an expectorant to loosen and thin mucus, dextromethorphan hydrobromide suppresses persistent coughing, and naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID), reduces fever and relieves body pain associated with viral respiratory infections. By integrating these ingredients into a single formulation, Reckitt has developed a first-of-its-kind OTC medicine capable of delivering prolonged symptom relief while improving treatment convenience. The product is intended to address the body’s inflammatory response triggered by cold and flu infections, allowing consumers to manage multiple symptoms with fewer doses throughout the day. Company researchers noted that the formulation is the result of more than 10 years of pharmaceutical research and development, representing one of the company’s most significant scientific achievements within the consumer health sector.
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Reckitt Expands Consumer Healthcare Innovation Portfolio
The FDA approval reinforces Reckitt’s long-term strategy of investing in science-driven consumer healthcare innovation while expanding access to effective self-care medicines. Seasonal influenza continues to affect millions of people annually, leading to substantial healthcare visits, workplace absences, and economic burden. As consumers increasingly rely on OTC medicines as their first line of treatment for common respiratory illnesses, innovations that provide extended symptom relief are becoming increasingly valuable. The nationwide launch of Mucinex 12HR Cold & Fever Multi-Symptom further expands Reckitt’s portfolio of trusted respiratory care products and reflects the company’s continued investment in pharmaceutical research, regulatory science, and patient-focused product development. Industry observers view the approval as an important milestone that could stimulate further innovation within the OTC cold and flu market while setting a new benchmark for long-lasting multi-symptom therapies. With its combination of FDA-approved technology, extended-release formulation, and multi-symptom efficacy, the newly approved medicine represents a significant advancement in accessible consumer healthcare and strengthens Reckitt’s leadership in respiratory wellness.
Source: Reckitt press release
