Reckitt’s Mucinex 12HR Cold & Fever Multi-Symptom Becomes First FDA-Approved OTC Cold and Flu Medicine in 14 Years

Reckitt has secured US Food and Drug Administration (FDA) approval for Mucinex 12HR Cold & Fever Multi-Symptom, marking the first FDA-approved over the counter (OTC) cold and flu medication in the United States in 14 years. The approval also represents the company’s first New Drug Application (NDA) cleared under the Reckitt name and the fourth FDA approval for the Mucinex brand portfolio.

The newly approved medicine combines three established active ingredients in a patented bilayer tablet that provides immediate and extended drug release, offering relief from multiple cold and flu symptoms for up to 12 hours with a single dose.

First Long-Acting Multi-Symptom OTC Option

Mucinex 12HR Cold & Fever Multi-Symptom is indicated to relieve fever, cough, chest congestion, and minor body aches and pains associated with colds and influenza. According to Reckitt, it is the first FDA-approved OTC product to combine guaifenesin, dextromethorphan hydrobromide, and naproxen sodium in a single bilayer formulation.

The product contains:

• Guaifenesin to thin and loosen mucus and relieve chest congestion
• Dextromethorphan HBr to suppress cough
• Naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID), to reduce fever and relieve pain

The bilayer tablet delivers an initial release followed by sustained drug delivery, allowing symptom control for up to 12 hours. Reckitt said this duration is up to three times longer than that provided by most currently available OTC cold and flu medicines.

Addressing a Significant Public Health Burden

Respiratory viral illnesses continue to place substantial pressure on healthcare systems and households across the United States. According to the US Centers for Disease Control and Prevention (CDC), the 2024-2025 influenza season resulted in an estimated 51 million illnesses, while the subsequent 2025-2026 season experienced an early nationwide surge in influenza activity.

Because many individuals rely on OTC medications as their first treatment option, longer-lasting symptom control may reduce the need for repeated dosing while helping patients manage symptoms during work, school, and daily activities.

Cold and flu symptoms arise largely from the body’s inflammatory response to viral infection. By combining an expectorant, cough suppressant, and anti-inflammatory agent, the new formulation targets multiple symptoms through complementary mechanisms in a single medicine.

More Than a Decade of Development

The FDA approval follows more than ten years of formulation research, clinical evaluation, and regulatory development by Reckitt. The company identified prolonged symptom relief as a major unmet need in the OTC cold and flu market and developed the bilayer technology to extend therapeutic activity without requiring frequent dosing.

Unlike many existing OTC products that require administration every four to six hours, the new medicine provides symptom relief with twice-daily dosing.

Executive Perspective

Jérôme Lemaire, President of Reckitt North America, said the approval reflects the company’s commitment to expanding access to science-based self-care products that better match consumer needs. He noted that longer-lasting symptom relief may help reduce the caregiving burden while allowing people to maintain their normal daily routines during common respiratory illnesses.

Angela Naef, PhD, Chief Research and Development Officer at Reckitt, said the approval represents the culmination of more than a decade of scientific research and formulation development. She highlighted the unique combination of active ingredients and extended-release delivery system as the key innovations behind the new medicine.

Commercial Launch and Outlook

Mucinex 12HR Cold & Fever Multi-Symptom is now available at retailers across the United States. The launch expands the Mucinex portfolio of 12-hour products, which has been used for more than two decades to relieve chest congestion and cough.

The approval introduces the first new FDA-approved OTC cold and flu medicine in more than a decade and adds a long-acting multi-symptom treatment option to a category that has seen limited regulatory innovation despite continued seasonal disease burden.

Reference

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 | Reckitt.com