Prescription and over-the-counter medicine
Tetracaine
Tetracaine is a prescription and over-the-counter medicine with an FDA approval on record since 2016. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $4.33 per mL (Tetracaine 0.5% eye drop) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tetracaine FDA label on DailyMed (effective January 19, 2024, Alcon Laboratories, Inc.); the NDA 208135 record on Drugs@FDA; every tetracaine label on DailyMed.
Highlights of the record
FDA label of January 19, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
Forms and strengths
- 5 mg/ml
Solution; solution/ drops.
On the market
- Earliest approval on file
- February 29, 2016 Tetracaine Hydrochloride, Alcon Labs; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first December 20, 2024; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 2 under generic applications, 6 under brand applications, repackagers included; 5 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $4.33 per mL Tetracaine 0.5% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest April 13, 2022; 2 more by firms not listed as its makers
- FAERS reports
- 123 through July 30, 2026
What is tetracaine used for?
From the label: indications and usageTetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
Conditions named in the indications of tetracaine's FDA labels, with every medicine labeled for each:
From other tetracaine labelsPain: Uses For temporary relief of pain and itching due to minor skin irritation.
FDA pharmacologic class: Ester Local Anesthetic.
Source: FDA drug label (Tetracaine Hydrochloride), Alcon Laboratories, Inc., effective January 19, 2024 (SPL set 5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79), via openFDA; the full label on DailyMed
Is there a generic for tetracaine?
The FDA approved the first generic tetracaine on December 20, 2024. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tetracaine from 2 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2016 earliest approval on file
- 2024 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tetracaine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.33 per mL (Tetracaine 0.5% eye drop), down 9% from $4.76 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tetracaine 0.5% eye drop (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tetracaine 0.5% eye drop | Generic | $4.33 per mL | n/a | -9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tetracaine been recalled?
The FDA's Enforcement Report lists 3 recalls naming tetracaine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of tetracaine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| November 14, 2014 | Class II | Attix Pharmaceuticals not a listed maker | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were … |
| March 20, 2013 | Class II | Clinical Specialties Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tetracaine label say about other medicines?
The tetracaine label names no other medicine on this site. The labels of 11 other medicines name tetracaine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Tetracaine Hydrochloride), Alcon Laboratories, Inc., effective January 19, 2024 (SPL set 5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79), via openFDA; the full label on DailyMed
What do FAERS reports show for tetracaine?
The FDA Adverse Event Reporting System holds 123 reports that list tetracaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17 are coded as a death and 29 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?
- Other ester local anesthetics
- the pharmacologic class, with prices and generics
- Tetracaine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other