The first FDA (Food and Drug Administration) approved OTC medication developed to meet consumer demand for longer-lasting cold and fever symptom relief* for 12 hours
A patented breakthrough combining three active ingredients in one category-first formulation
The first FDA-approved innovation in the cold and flu category in 14 years marking Reckitt's first approved New Drug Application (NDA)
For decades, cold and flu symptoms have often outlasted the relief from over-the-counter medicines. While symptoms can persist throughout the day and night, many treatments require consumers to re-dose every few hours, creating disruption at a time when they need relief most.
Consumer research showed that 64% of people wanted longer-lasting symptom relief with fewer interruptions.
For Reckitt, this represented a clear unmet consumer need and an opportunity to redefine cold and fever symptom management. Teams across R&D, Commercial, Regulatory Supply and Quality came together with a bold ambition to develop a solution that could deliver long-lasting, multi-symptom relief in one dose.
What followed was more than a decade of development, research, problem-solving and collaboration. The challenge was complex combining three active ingredients with different characteristics to work together in harmony in a single tablet to deliver immediate release and long lasting relief from cold and fever symptoms.
No over the counter medicine had achieved this before.
“At Reckitt, we believe the best innovations start with a deep understanding of unmet consumer needs. This innovation reflects years of scientific expertise and cross-functional collaboration to solve a challenge that mattered to consumers and had not previously been addressed in the category.”
Ryan Dullea
Chief Category Growth Officer
With that ambition in mind, teams across the business set out to tackle a challenge that had never been solved before, delivering long-lasting cold and fever symptom relief in a single dose.
Mucinex, the No. 1 physician-trusted brand, has been innovating in cold and relief since its launch in 2002. Over more than two decades, it has built a portfolio of more than 60 products spanning chest congestion relief, cough suppression, multi-symptom relief and fever and pain relief. Its innovation has also extended across formats from tablets and liquids to nasal sprays, lozenges and children’s liquids and soft chews, giving the brand expertise across symptoms, needs and occasions.
Building on that expertise, scientists at Reckitt's Science and Innovation Centre in Hull, UK, turned to developing a formulation that could tackle multiple symptoms and longer relief.
"We attempted to bring an innovation to the consumer which hadn't been developed yet."
Tim Shea
Senior Medical Scientist, Upper Respiratory
Three challenging actives, one breakthrough
The objective was clear but difficult to formulate – one tablet containing three actives, each with a different job to do.
Guaifenesin
An expectorant that loosens mucus and helps relieve chest congestion.
Dextromethorphan HBr
A cough suppressant that helps control the cough reflex.
Naproxen sodium
An NSAID (nonsteroidal anti-inflammatory drug) that targets inflammation, helping to reduce fever and relieve body aches.
Each active worked differently in the body, so the challenge was making sure they worked together in the right way, releasing at the right time to provide relief for 12 hours.
The tablet was designed to replicate the drug release profile for the existing four-hour products on the market, delivering an initial immediate release of actives followed by controlled release over time to provide sustained relief for 12 hours.
That complexity shaped the innovation.
The result was a patented bi-layer caplet that uses dual-release technology to control the release of ingredients over time to bring immediate and extended release. The formulation is designed to start relief and keep it going for 12 hours.
"The breakthrough moment was that we could actually prove in clinical studies that the product lasted twelve hours."
Sapphira Parrott
R&D Quality Manager
Mucinex® 12HR Cold & Fever Multi-Symptom became the first OTC medication to help relieve fever, body ache, cough, excess mucus and chest congestion for 12 hours.
From lab to launch
Proving the science was a major milestone. Bringing Mucinex 12HR to consumers came with more challenges.
"We had everything you could possibly think of thrown at the project." says Kris Hall, R&D Senior Manager, Cold & Flu Mucinex.
Clinical trials were disrupted by the COVID-19 pandemic, requiring a second study to be mounted on an expedited timeline. Volcanic ash clouds and fire at a supplier’s factory created supply chain disruptions. Then the manufacturing team also experienced a product stability setback forcing them to rethink production and packaging approaches for ensuring the caplet could be scaled from a handful to millions, consistently.
Then after Food and Drug Administration (FDA) reviewed the data, it requested additional evidence for the 12-hour claim. The team responded on an expedited timeline.
In December 2025, the FDA approved Mucinex 12HR Cold & Fever Multi-Symptom. It was the first New Drug Application (NDA) approved in the cold and fever category in 14 years and a category first OTC medication to help reduce fever, and relieve body ache, cough, excess mucus and chest congestion for 12 hours.
It was also the first FDA-approved NDA under the Reckitt name, marking a significant milestone for both brand and the category.
Breakthrough to benchmark
Sixteen internal teams worked across formulation, clinical, regulatory, manufacturing and commercial development. Each played a part in taking up innovation from formulation and testing through approvals, scale-up and launch.
"Working together as one global team, we developed a first-of-its-kind OTC medication for the number one unmet need in the category." says Chloe Druskin, Brand Manager, Mucinex.
The journey from consumer insight to an FDA-approved medicine took more than a decade of science. It shows what can happen when an unmet consumer need is matched with commitment and cross-functional collaboration.
Ultimately, it is about turning a consumer need into better solutions and helping deliver better health in more hands, every day.
*Clear C&F U&A 2022
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