Firm's Initial New Drug Approval¹ Targets Top Unmet Need for Extended Symptom Relief*

Mucinex 12HR Cold and Fever Multi-Symptom marks the first and only FDA-approved OTC cold and flu treatment addressing fever, cough, chest congestion and body pain for 12 hours
This represents the fourth FDA approval for the Mucinex brand family
Mucinex 12HR Cold and Fever Multi-Symptom is now stocked at retailers across the nation

, /PRNewswire/ - Reckitt revealed today a key achievement for the cold and flu sector and the firm: Mucinex 12HR Cold and Fever Multi-Symptom stands as the first U.S. Food and Drug Administration (FDA)-approved over-the-counter (OTC) advancement in the cold and flu sector in 14 years, and the initial New Drug Application (NDA) under the Reckitt name to gain FDA clearance.¹ Created to match how consumers prefer to handle cold and flu symptoms, this success stems from more than ten years of Reckitt scientific study, formulation work, clinical testing and regulatory efforts.

The clearance arrives as cold and flu continue to impose a growing load on Americans, leading to millions of cases, medical appointments and lost work or school days annually. Per The Centers for Disease Control and Prevention (CDC), the 2024-25 flu period caused an estimated 51 million illnesses, while the 2025-26 period brought a rise in flu activity nationwide that aligned with an earlier start.² With people turning to OTC options as their primary self-care approach, broadening access to fresh solutions offering safe, reliable and easy relief grows more essential.

"This achievement highlights Reckitt's focus on providing reliable, evidence-based options that address routine health needs and align with American lifestyles," said Jérôme Lemaire, President, Reckitt North America. "By moving the cold and flu sector forward with extended 12-hour symptom relief, we expand options and access for consumers while reducing the load on families and helping individuals maintain their routines."

Cold and flu effects stem largely from the body's inflammatory reaction to infection.³ Noting the part inflammatory responses play in many symptoms, Mucinex 12HR Cold and Fever Multi-Symptom was built to deliver extended multi-symptom relief. As the first item in its group to blend guaifenesin, dextromethorphan HBr and naproxen sodium - an NSAID - in a bilayer tablet, it provides quick and sustained release of ingredients for relief lasting up to three times longer than most cold and flu treatments.**

"Real progress begins with grasping consumer needs and using science to meet them," said Angela Naef, Ph.D., Chief R and D Officer, Reckitt. "This clearance caps more than a decade of study and formulation work to produce a novel blend that supplies extended relief from several cold and flu symptoms."

About Mucinex 12HR Cold and Fever Multi-Symptom

Mucinex 12HR Cold and Fever Multi-Symptom is a novel OTC treatment built to tackle the top unmet need in the cold and flu sector - extended symptom relief* - offering up to 12 hours of relief from one dose. With a patented bi-layer tablet, Mucinex 12HR Cold and Fever Multi-Symptom merges three active components for strong and simple relief: guaifenesin (expectorant), dextromethorphan HBr (cough suppressant) and naproxen sodium (NSAID for fever and pain).

Reckitt introduced Mucinex 12HR Cold and Fever Multi-Symptom in 2026, growing the brand's range of 12-hour items trusted for over 20 years to thin and loosen extra mucus, ease chest congestion and manage coughing. Supported by more than ten years of scientific study and formulation, this advance shows Reckitt's dedication to science-based options that meet real needs in the cold and flu sector.

About Reckitt

We produce items people rely on to care for loved ones. We house some of the world's most popular consumer health and hygiene brands, including Dettol, Durex, Finish, Gaviscon, Harpic, Lysol, Mucinex, Nurofen, Strepsils, Vanish and Veet. Consumers sit at the core of all we do. By building innovative, science-based solutions, we aid people daily in living healthier lives.

Reckitt works to protect, heal and nurture toward a cleaner, healthier world. This pledge extends past the items we create. Through our efforts, we widen access to healthcare, education and economic chances. We aid the planet by cutting waste, saving resources and promoting sustainable progress.

We hold that good health begins at home. With each step we take, we aim to simplify, clean and improve our consumers' lives, bolster communities and build a more sustainable future.

Learn more or contact us at Reckitt.com/us.

Reckitt serves as the trading name of the Reckitt group of companies

*Clear C and F U and A 2022
** Compared to 1 dose of 4-hour medicine without re-dosing.

References

¹ U.S. Food and Drug Administration. (2026). Drugs@FDA: FDA-Approved Drugs: Mucinex 12HR Cold and Fever Multi-Symptom, New Drug Application approval.

² Centers for Disease Control and Prevention. (2026, July). Vital Statistics Rapid Release, Report No. 44: Mortality in the United States, Provisional Data, 2025. National Center for Health Statistics.

³ Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis 2005 Nov;5(11):718-25

Media Contact:
Jen O'Neill
Reckitt (U.S)
[email protected]

Will Hill
Reckitt (UK)
media@[email protected]

SOURCE Reckitt