Yes, cocaine is FDA approved, but only in two specific prescription products used by physicians during nasal procedures. Goprelto, cleared in December 2017, and Numbrino, cleared in January 2020, are both cocaine hydrochloride nasal solutions approved for one purpose: numbing the lining of the nose during diagnostic procedures and surgeries in adults. Outside that clinical setting, cocaine has no approved medical use in the United States.
The Two Approved Cocaine Products
Goprelto is a 4% cocaine hydrochloride nasal solution approved on December 14, 2017, for local anesthesia of the nasal mucous membranes during diagnostic procedures and surgeries in adults.1FDA Drug Labeling Information. GOPRELTO Cocaine Hydrochloride Nasal Solution – Full Prescribing Information Numbrino, approved on January 10, 2020, is also a cocaine hydrochloride nasal solution cleared for the same indication.2Food and Drug Administration. NUMBRINO Cocaine Hydrochloride Nasal Solution CII – Drug Label
Cocaine is a Schedule II controlled substance under the Controlled Substances Act, meaning federal law recognizes both a high potential for abuse and a currently accepted medical use.3Office of the Law Revision Counsel. 21 USC 812 – Schedules of Controlled Substances That accepted use is what these two approvals reflect. Neither product is dispensed to patients for home use; both are used in the clinical setting under direct physician supervision.
How Approved Cocaine Is Actually Used
Despite sometimes being described as nasal sprays, neither Goprelto nor Numbrino is sprayed. The solution is used to soak small cotton or rayon pledgets, which the physician then places directly against the inside of the nose. For Goprelto, the standard application is two soaked pledgets per nostril, delivering 160 mg of cocaine hydrochloride across four pledgets.1FDA Drug Labeling Information. GOPRELTO Cocaine Hydrochloride Nasal Solution – Full Prescribing Information
Cocaine does two useful things at once in an ENT setting: it numbs tissue and it constricts blood vessels to control bleeding. The American Academy of Otolaryngology–Head and Neck Surgery has noted that no other single drug combines both properties as effectively.4American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Position Statement: Medical Use of Cocaine Physicians can achieve a similar result by combining lidocaine with oxymetazoline, but that requires two drugs rather than one.
Who Should Not Receive It
Even applied to nasal tissue, cocaine can be absorbed into the bloodstream in meaningful amounts. It raises heart rate and blood pressure and increases the heart’s oxygen demand. Patients with hypertension or cardiovascular disease are generally considered poor candidates.
Neither product is approved for children. Goprelto’s labeling states that safety and effectiveness in patients 17 and younger has not been established, and juvenile animal studies showed central nervous system effects and reduced body weight at doses above the human equivalent.1FDA Drug Labeling Information. GOPRELTO Cocaine Hydrochloride Nasal Solution – Full Prescribing Information Goprelto’s Phase 3 trial found no overall difference in safety or effectiveness between elderly patients and younger adults, though the labeling notes that some older patients may be more sensitive.
Combining cocaine with epinephrine is considered dangerous. It offers no added benefit for nasal vasoconstriction and creates unnecessary cardiac risk.
What About Other Cocaine Solutions?
For decades before Goprelto’s approval, physicians used generic 4% and 10% cocaine hydrochloride topical solutions during ENT work. Those products were never FDA approved. After Goprelto cleared review, the FDA formally notified manufacturers that all other cocaine hydrochloride solution products are unapproved new drugs that may not be distributed in interstate commerce, and identified four specific unapproved products (two at 4% and two at 10%) that had to come off the market.5U.S. Food and Drug Administration. FDA Notification Regarding Cocaine Hydrochloride Solution Products Goprelto and Numbrino are the only cocaine products with FDA approval.
Drug Testing After a Nasal Procedure
If cocaine is used during your procedure, you will test positive on a standard drug screen. Metabolites typically show up in urine for two to three days and in blood for roughly 48 hours. Hair testing can detect cocaine for months.
For workers under Department of Transportation testing rules, a Medical Review Officer reviews every confirmed positive and must give you a chance to explain. A valid prescription consistent with the Controlled Substances Act is a legitimate medical explanation, and the MRO cannot second-guess whether your physician should have ordered it. If the MRO accepts the explanation, the result is reported as negative.6eCFR. 49 CFR 40.137 – On What Basis Does the MRO Verify Test Results Involving Marijuana, Cocaine, Amphetamines, Semi-Synthetic Opioids, or PCP
The burden of proof is on you, so ask your doctor for written documentation of the procedure and the drug used. Employers outside the DOT framework set their own protocols, and notifying a testing program in advance is worth doing if a screen is likely to fall soon after your procedure.
Cost on Your Bill
When Goprelto or Numbrino is used, the cost of the drug is typically bundled into the facility’s charge for the procedure rather than billed separately. The Centers for Medicare and Medicaid Services reviewed whether cocaine hydrochloride nasal solution needed its own billing code and concluded that the drug’s cost would normally be captured in the payment for the procedure itself, so no separate payment was necessary.7Centers for Medicare & Medicaid Services (CMS). First Quarter 2025 HCPCS Coding Cycle – Drugs and Biologicals With private insurance, coverage depends on the underlying procedure’s medical necessity, not the anesthetic.
Possession Outside the Clinic
The narrow medical approval does not extend to anything else. Possessing cocaine without a valid prescription is a federal crime, and the penalties for simple possession climb with each conviction:8Office of the Law Revision Counsel. 21 USC 844 – Penalties for Simple Possession
- First offense: up to one year in prison, a minimum $1,000 fine, or both.
- Second offense: 15 days to two years in prison and a minimum $2,500 fine, with the minimum sentence not subject to suspension or deferral.
- Third or subsequent offense: 90 days to three years in prison and a minimum $5,000 fine, again with no suspension of the minimum.
Distribution and trafficking carry far harsher sentences, and state penalties vary. The legal line is simple: cocaine applied by a physician to your nasal tissue during a documented procedure is lawful; cocaine anywhere else is not.