Prescription medicine
Cocaine Brand names: Numbrino, Goprelto
Cocaine (Numbrino) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the cocaine FDA label on DailyMed (effective January 12, 2026, OMNIVIUM PHARMACEUTICALS LLC.); the NDA 209963 record on Drugs@FDA; every cocaine label on DailyMed.
Highlights of the record
FDA label of January 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ABUSE AND DEPENDENCE.
CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. ( 5.1 ) WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence.
Used for
From the label: indications and usageNUMBRINO (cocaine hydrochloride) nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
Forms and strengths
- 40 mg/ml
Solution.
On the market
- Earliest approval on file
- December 14, 2017 Goprelto, Lxo Ireland; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- February 7, 2037 Numbrino solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 417 through July 30, 2026
What is cocaine used for?
From the label: indications and usageNUMBRINO (cocaine hydrochloride) nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. NUMBRINO (cocaine hydrochloride) nasal solution is an ester local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
Source: FDA drug label (NUMBRINO), OMNIVIUM PHARMACEUTICALS LLC., effective January 12, 2026 (SPL set d724b5b4-6654-4bf5-9eed-e2c7943084ed), via openFDA; the full label on DailyMed
Is there a generic for cocaine (Numbrino)?
No generic cocaine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 11 patents for Numbrino solution, the last expiring on February 7, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cocaine label say about other medicines?
The cocaine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name cocaine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclophosphamide | drug interactions | Plasma cholinesterase activity may be decreased by chronic administration of certain monoamine oxidase inhibitors, oral contraceptives, glucocorticoids, antimyasthenics (neostigmine), cyclophosphamide, and possibly thiotepa. |
| Disulfiram | drug interactions | Disulfiram treatment increases plasma cocaine exposure. |
| Echothiophate | drug interactions | It may also be diminished by administration of irreversible plasma cholinesterase inhibitors such as echothiophate, organophosphate insecticides, and certain antineoplastic agents. |
| Epinephrine | drug interactions | Avoid use of additional vasoconstrictor agents such as epinephrine and phenylephrine with NUMBRINO during nasal and sinus surgery. |
| Phenylephrine | drug interactions | Avoid use of additional vasoconstrictor agents such as epinephrine and phenylephrine with NUMBRINO during nasal and sinus surgery. |
| Thiotepa | drug interactions | Plasma cholinesterase activity may be decreased by chronic administration of certain monoamine oxidase inhibitors, oral contraceptives, glucocorticoids, antimyasthenics (neostigmine), cyclophosphamide, and possibly thiotepa. |
Other labels that name cocaine
Source: FDA drug label (NUMBRINO), OMNIVIUM PHARMACEUTICALS LLC., effective January 12, 2026 (SPL set d724b5b4-6654-4bf5-9eed-e2c7943084ed), via openFDA; the full label on DailyMed
What do FAERS reports show for cocaine?
The FDA Adverse Event Reporting System holds 417 reports that list cocaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 248 are coded as a death and 152 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Cocaine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other