Active ingredient
Tetracaine
17 finished FDA listings contain Tetracaine as their only active ingredient; 11 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TETRACAINE, TETRACAINE HYDROCHLORIDE
- Dosage forms
- Cream, Gel, Injection, Ointment, Solution, Solution/ Drops
- Routes
- Ophthalmic, Subarachnoid, Topical
- Manufacturers / labelers
- 15
- Strengths listed
- 10 mg/ml · 2 g/100g · 2 g/100ml · 20 mg/1000mg · 20 mg/1000ml · 20 mg/g · 5 mg/ml
- Brand names in FDA listings
- Blt 3, Neuromed Topical Analgesic La, Numfast Tetracaine Green, Painless Tattoo 3
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10391
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 208135 | ALCON LABS | 2016-02-29 | 3 |
| NDA 210821 | BAUSCH LOMB IRELAND | 2019-03-12 | 4 |
| ANDA 217227 | SOMERSET THERAPS LLC | 2024-12-20 | 4 |
Official labeling on DailyMed
- TETRACAINE HYDROCHLORIDE SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-08-31
- TETRACAINE HYDROCHLORIDE SOLUTION [SPORTPHARM LLC] · version 1 · 2026-07-10
- TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.] · version 4 · 2026-02-09
- TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [OCEANSIDE PHARMACEUTICALS] · version 6 · 2026-01-26
- BLT 3 (TETRACAINE) OINTMENT [CENTURA PHARMACEUTICALS INC] · version 8 · 2026-01-14
- TETRACAINE GEL [BELLUS MEDICAL, LLC] · version 4 · 2026-01-12
- TETRACAINE HCL INJECTION [BPI LABS LLC] · version 9 · 2025-12-29
- TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH HEALTH US LLC] · version 2 · 2025-12-08
- NEUROMED TOPICAL ANALGESIC LA (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.] · version 11 · 2025-11-17
- PAINLESS TATTOO 3 (TETRACAINE) CREAM [SAMBRIA PHARMACEUTICALS, LLC] · version 5 · 2025-11-17
- TETRACAINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS] · version 9 · 2025-02-13
- TETRACAINE HYDROCHLORIDE SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 2 · 2024-12-23
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.