FDA expands OTC naloxone options for opioid overdose

FDA has approved Rextovy (naloxone hydrochloride) 4 mg nasal spray for over-the-counter use, adding to the growing market of nonprescription naloxone products. The approval increases direct consumer access to a medication that can rapidly reverse the effects of opioid overdose.

Although overdose deaths in the United States continue to decline, they remain a major public health concern. FDA reported that overdose deaths fell from more than 111,000 during the 12-month period ending in August 2023 to approximately 68,600 during the 12-month period ending in December 2025, but synthetic opioids such as illicit fentanyl continue to drive much of the ongoing mortality burden.

Rextovy contains the same active ingredient and dose as other approved naloxone nasal sprays and is intended for emergency treatment of known or suspected opioid overdose. The product includes illustrated instructions and emphasizes calling 911 immediately after administration of the first dose.

FDA noted that naloxone is safe to administer even when it is uncertain whether opioids are present in a person's system. Following reversal, some individuals may experience symptoms such as shaking, sweating, nausea, or agitation as opioid effects are rapidly reversed.

The growing availability of OTC naloxone products may influence clinical practice by making overdose prevention counseling more actionable. Clinicians can now direct patients and families to multiple nonprescription naloxone options available through pharmacies, convenience stores, and online retailers without the need for a prescription.

“Immediate access to naloxone nasal sprays is essential when a person is experiencing an overdose, and FDA remains committed to ensuring nonprescription options are widely available,” said Karen Murry, MD, director of the FDA Office of Nonprescription Drug Products.

Source: FDA. 2026 June 16. [Press release]. FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose