FDA’s Push To Reclassify The Opioid Reversal Agent Naloxone As An OTC Product Needs To Show More Urgency The FDA’s push to reclassify naloxone as an OTC product appears tepid and plodding. At a time when the nation is enduring a severe public health emergency - with record numbers of (illicit) opioid overdose-related deaths - it’s crucial that naloxone become available OTC as soon as possible.