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  1. Unapproved Drugs

FDA notification regarding cocaine hydrochloride solution products

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:

Drug NDC

Drug name


4% Cocaine Hydrochloride Topical Solution 4mL


4% Cocaine Hydrochloride Topical Solution 10mL


10% Cocaine Hydrochloride Topical Solution 4mL


10% Cocaine Hydrochloride Topical Solution 10mL

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.

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