FDA requested companies stop distributing unapproved versions of cocaine hydrochloride solution.

The agency approved Genus Lifesciences Inc.’s Goprelto (cocaine hydrochloride) nasal solution (NDC 64950-0359) on December 14, 2017. All other cocaine hydrochloride products are unapproved new drugs that cannot be distributed in interstate commerce without a new drug application approved by FDA, including:

FDA encourages all drug companies of unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drug marketed in the United States.