Quick answers
- What is Cocaine hydrochloride used for?
- The FDA-approved label (Goprelto, LXO US Inc., November 6, 2024) says: “GOPRELTO (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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cocaine hydrochloride have a boxed warning?
- Yes. The FDA label for Goprelto has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Cocaine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cocaine hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cocaine hydrochloride?
- 2 companies list prescription products of Cocaine hydrochloride in the FDA NDC Directory, including LXO US Inc. and Omnivium Pharmaceuticals LLC..
What Cocaine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GOPRELTO (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. …
— FDA label: Goprelto, LXO US Inc., effective November 6, 2024. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
4 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- LXO US Inc.2 products
- Omnivium Pharmaceuticals LLC.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1995288, 1995293, 2272608 |
|---|---|
| SPL set ID of the quoted label | 0f897764-fe30-090a-e063-6294a90af106 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA209575, NDA209963 |
| Active ingredients (FDA) | COCAINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Goprelto, LXO US Inc., effective November 6, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →