Active ingredient
Cocaine
4 finished FDA listings contain Cocaine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- COCAINE HYDROCHLORIDE
- Dosage forms
- Solution
- Routes
- Nasal, Topical
- Manufacturers / labelers
- 3
- Strengths listed
- 40 mg/ml
- Brand names in FDA listings
- Goprelto, Numbrino
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2653
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 209963 | LXO IRELAND | 2017-12-14 | 2 |
| NDA 209575 | OMNIVIUM PHARMS | 2020-01-10 | 2 |
Official labeling on DailyMed
- NUMBRINO (COCAINE HYDROCHLORIDE NASAL) SOLUTION [OMNIVIUM PHARMACEUTICALS LLC.] · version 3 · 2026-01-19
- GOPRELTO (COCAINE HYDROCHLORIDE) SOLUTION [LXO US INC.] · version 1 · 2024-11-07
- COCAINE HYDROCHLORIDE SOLUTION [LXO US INC.] · version 1 · 2024-01-29
- COCAINE HYDROCHLORIDE NASAL SOLUTION [OMNIVIUM PHARMACEUTICALS LLC.] · version 1 · 2023-10-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.