FDA Approves Mucinex 12HR Cold & Fever Multi-Symptom for OTC Use

Reckitt announced US Food and Drug Administration (FDA) approval of Mucinex 12HR Cold & Fever Multi-Symptom on August 5, 2026, making it the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion and body pain for 12 hours. The fixed-dose product contains guaifenesin, dextromethorphan hydrobromide, and naproxen sodium in a bilayer tablet.¹

The approval was granted through a new drug application (NDA), according to an August 5, 2026, press release from Reckitt, and marks the first OTC innovation in the cold and flu category in 14 years. The company described the decision as its first NDA approval under the Reckitt name and the fourth FDA approval involving the Mucinex product family.¹ The product is now available through US retailers.

"True innovation starts with understanding consumer needs and applying science to solve them," said Angela Naef, PhD, Chief R&D Officer, Reckitt. "This approval is the culmination of more than a decade of research and development to create a first-of-its-kind formulation that delivers long-lasting relief from multiple cold and flu symptoms."

What Is Included in Mucinex 12HR Cold & Fever Multi-Symptom?

The formulation combines 3 active ingredients with distinct symptom-focused roles. Guaifenesin is an expectorant used to thin and loosen mucus, while dextromethorphan hydrobromide acts as a cough suppressant. Naproxen sodium, a nonsteroidal anti-inflammatory drug, is included for relief of fever and pain. The bilayer tablet provides immediate and extended release, according to the company.

Reckitt characterized the product as the first FDA-approved OTC cold and influenza medication combining these ingredients for up to 12 hours of multisymptom relief. This description reflects the company’s comparison with shorter-acting products and should not be interpreted as evidence of antiviral activity or reduced illness duration. The formulation is intended for symptomatic management.

Inflammatory responses associated with respiratory infections contribute to fever, pain, congestion, and other manifestations of the common cold and influenza.² However, the relative contribution of individual pathways varies by infection and symptom. The newly approved combination does not treat the underlying viral infection, based on the indication described in the announcement.

Reckitt reported more than a decade of research, development, clinical evaluation, and regulatory engagement preceding the NDA approval.

The announcement also described the approval as the first OTC cold and influenza category innovation in 14 years. The regulatory action applies to symptom relief in the United States and does not establish efficacy for preventing influenza complications, transmission, hospitalization, or other infection-related outcomes.

"This milestone reinforces Reckitt's commitment to delivering trusted, science-backed solutions that meet everyday health needs and truly fit how Americans live," said Jérôme Lemaire, President, Reckitt North America. "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."

References

1. Reckitt. Reckitt announces US FDA approval of Mucinex 12HR Cold & Fever Multi-Symptom, the first OTC innovation in the cold & flu category in 14 years. Published August 5, 2026. https://www.prnewswire.com/news-releases/reckitt-announces-us-fda-approval-of-mucinex-12hr-cold--fever-multi-symptom-the-first-otc-innovation-in-the-cold--flu-category-in-14-years-302842875.html

2. Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005;5(11):718-725.