The FDA approved over-the-counter Mucinex 12hr Cold & Fever Multi-Symptom.


RT’s Three Key Takeaways:

  1. FDA Approval: The Food and Drug Administration (FDA) approved Mucinex 12hr Cold & Fever Multi-Symptom, marking the first over-the-counter innovation in the cold and flu category in 14 years.
  2. Triple-Action Formula: The medication combines an expectorant, a cough suppressant, and a non-steroidal anti-inflammatory drug in a single bi-layer tablet to provide relief for up to 12 hours.
  3. Clinical Development: The approval follows more than a decade of research and clinical evaluation aimed at addressing the need for long-lasting symptom management during the cold and flu season.


The USFDA approved over-the-counter Mucinex 12hr Cold & Fever Multi-Symptom, according to Reckitt.

The approval comes as cold and flu continue to place a significant burden on US healthcare systems. 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 an early surge in cases across the country, according to the release.

The medication was developed to address the inflammatory response to infection that drives many cold and flu symptoms. It is the first product in its category to combine guaifenesin, dextromethorphan HBr, and naproxen sodium—a non-steroidal anti-inflammatory drug (NSAID)—in a bi-layer tablet. This design delivers immediate and extended release of active ingredients, providing symptom relief that lasts up to three times longer than 4-hour cold and flu medications, according to the company.

“True innovation starts with understanding consumer needs and applying science to solve them,” said Angela Naef, 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.”

Reckitt launched the product in 2026, expanding its portfolio of 12-hour treatments designed to thin and loosen excess mucus, relieve chest congestion, and control coughing. The company stated the formulation addresses the top unmet need in the category for long-lasting symptom relief.