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Shares of Kenvue (KVUE) rose about 2% on Friday after the company announced that the U.S. Food and Drug Administration has approved Tylenol with Naproxen, a new over-the-counter pain reliever.
The product pairs 650 mg of acetaminophen with 220 mg of naproxen sodium in a single dose. It begins working in under 30 minutes and provides up to 12 hours of pain relief. It is opioid-free and intended for the temporary relief of pain, the company said. Clinical studies showed it provided superior pain relief compared with either acetaminophen or naproxen sodium alone.
The FDA granted Kenvue three years of exclusivity for the new formulation.Tylenol with Naproxen will be available soon at major U.S. retailers nationwide, Kenvue said.
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The green light arrives despite continued pressure on the Tylenol brand. In September 2025, President Donald Trump and members of his administration claimed that acetaminophen use during pregnancy may be linked to autism, urging pregnant women to avoid the drug. The comments triggered a sharp drop in Kenvue’s stock at the time and drew widespread pushback from doctors, medical groups and international health agencies, who said the science does not support a causal link.
Kenvue has repeatedly stated that decades of evidence show Tylenol is safe when used as directed.
Tylenol is Kenvue’s flagship pain-relief brand and one of its most important products. Analysts estimate it generates roughly $1 billion in annual sales and accounts for about 8–10% of the company’s total revenue. It anchors the company’s Self Care segment, which delivered more than $6 billion in sales in 2025, and continues to drive innovation for the company.
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On Stocktwits, retail sentiment around KVUE rose from ‘neutral’ to ‘bullish’ over the past 24 hours, while message volume stayed at ‘low’ levels.
KVUE stock has gained 12% year-to-date.
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