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Numbrino FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 29, 2020.

FDA Approved: Yes (First approved January 10, 2020)
Brand name: Numbrino
Generic name: cocaine hydrochloride
Dosage form: Nasal Solution
Company: Lannett Company, Inc.
Treatment for: Nasal Anesthesia

Numbrino (cocaine hydrochloride) nasal solution is a 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.

  • Numbrino is administered via soaked cotton or rayon applicator pledgets which are applied to the nasal mucosa for 20 minutes.
  • Numbrino may lower seizure threshold, and can cause increases in blood pressure and heart rate. Common side effects (> 1%) include hypertension, tachycardia, and sinus tachycardia.
  • Cocaine is a Schedule II substance under the Controlled Substances Act. Cocaine hydrochloride and its metabolites in Numbrino may be detected in plasma for up to one week after administration, and in urine toxicology screening for longer than one week after administration.

Development timeline for Numbrino

Jan 13, 2020Approval FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.