FDA Expands OTC Options for Opioid Overdose Reversal

The FDA approved another opioid overdose reversal product for over-the-counter (OTC) use, the agency announced on Tuesday.

The 4-mg intranasal naloxone hydrochloride (Rextovy) nasal spray joins other similar nonprescription products indicated for the emergency treatment of an opioid overdose. The first OTC naloxone was approved in 2023.

“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,” Karen Murry, MD, the director of the agency’s Office of Nonprescription Drug Products, said in a statement.

Overdose deaths have plummeted in recent years following a dramatic spike during the pandemic that’s been fueled mostly by synthetic opioids such as fentanyl. Deaths reached 110,000 in 2022 but declined to about 69,000 in 2025, according to CDC data.

Experts credit multiple potential factors for the decline, including changes in how people use and in the fentanyl supply from China, and improved access to medication for opioid addiction. The increased availability of naloxone with the move to OTC has been cited as well, though researchers found sales to be limited following an initial surge after the first nonprescription option became available.

The agency said its approval of multiple OTC naloxone nasal sprays — which can be purchased at pharmacies, online, and at convenience stores — not only expands access and sourcing options, but also fosters competition, which could potentially reduce costs. In its press release, FDA encouraged other manufacturers to pursue nonprescription naloxone approvals.

Naloxone is safe even when it’s unclear whether opioids are in a person’s system, the FDA said. Expected side effects when used for opioid overdose reversal may include shaking, sweating, nausea, and anger as people awaken from an overdose. The person administering the product should call 911 after giving the first dose, and then give further doses if the suspected overdose victim does not wake up after a few minutes, according to the user instructions.