Quick answers
- What is Tetracaine hydrochloride used for?
- The FDA-approved label (Tetracaine Hydrochloride, Sportpharm LLC, July 3, 2026) says: “Tetracaine 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Tetracaine hydrochloride?
- The “Adverse Reactions” section of the FDA label (Tetracaine Hydrochloride, Sportpharm LLC, July 3, 2026) begins: “The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal Injury with Intracameral Use [see Warnings and Precautions (5.1)] Corneal Toxicity [see Warnings and Precautions (5.2)] Corneal Injury Due to Insensitivity [see Warnings and Precautions (5.3)] The following adverse reactions have been identified following use of tetracaine hydrochloride ophthalmic solution, 0.5%.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tetracaine hydrochloride have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tetracaine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tetracaine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tetracaine hydrochloride?
- 9 companies list prescription products of Tetracaine hydrochloride in the FDA NDC Directory, including Sportpharm LLC, Somerset Therapeutics, LLC and Bausch Health US, LLC.
What Tetracaine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tetracaine 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.
— FDA label: Tetracaine Hydrochloride, Sportpharm LLC, effective July 3, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (solution, ophthalmic), Tetracaine Hydrochloride, Sportpharm LLC; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 9 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.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Tetracaine hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal Injury with Intracameral Use [see Warnings and Precautions (5.1)] Corneal Toxicity [see Warnings and Precautions (5.2)] Corneal Injury Due to Insensitivity [see Warnings and Precautions (5.3)] The following adverse reactions have been identified following use of tetracaine hydrochloride ophthalmic solution, 0.5%.
Read more of this section
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. (6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Tetracaine Hydrochloride, Sportpharm LLC, effective July 3, 2026. Read the full label on DailyMed →
Tetracaine hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
One drop topically in the eye(s) as needed. One drop topically in the eye(s) as needed. (2)
— FDA label: Tetracaine Hydrochloride, Sportpharm LLC, effective July 3, 2026. Read the full label on DailyMed →
Tetracaine hydrochloride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary There are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution, 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.
— FDA label: Tetracaine Hydrochloride, Sportpharm LLC, effective July 3, 2026. Read the full label on DailyMed →
When Tetracaine hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. (4)
— FDA label: Tetracaine Hydrochloride, Sportpharm LLC, effective July 3, 2026. Read the full label on DailyMed →
Tetracaine hydrochloride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Prolonged use of a topical ocular anesthetic including tetracaine hydrochloride ophthalmic solution, 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.
— FDA label: Tetracaine Hydrochloride, Sportpharm LLC, effective July 3, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution · Solution/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 11 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tetracaine hydrochloride 5 mg/mL solution | Generic | $4.68 per mL |
| tetracaine hydrochloride 5 mg/mL solution/ drops | Generic | $4.68 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Sportpharm LLC2 products
- Somerset Therapeutics, LLC2 products
- Bausch Health US, LLC1 product
- Alcon Laboratories, Inc.1 product
- Bausch & Lomb Incorporated1 product
- Remedyrepack Inc.1 product
- Oceanside Pharmaceuticals1 product
- Bausch & Lomb Americas Inc.1 product
- A-S Medication Solutions1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208135 TETRACAINE HYDROCHLORIDE | Alcon Labs | February 29, 2016 | 1, latest February 28, 2022 2022: Labeling |
| NDA210821 TETRACAINE HYDROCHLORIDE | Bausch Lomb Ireland | March 12, 2019 | 1, latest February 22, 2022 2022: Labeling |
Generic approvals (1)
- ANDA217227Somerset Theraps LLC · December 20, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1113-2022
cGMP deviations: Temperature abuse
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1547771 |
|---|---|
| SPL set ID of the quoted label | 90ffa320-652b-442f-97fa-6d618439db79 |
| FDA labels (SPL) | 9 |
| FDA applications | NDA208135, NDA210821, 1 ANDA |
| Active ingredients (FDA) | TETRACAINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Tetracaine sold over the counterDrug Facts label and store brands
- Sportpharm LLCMaker or distributor
- Somerset Therapeutics, LLCMaker or distributor
- Bausch Health US, LLCMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tetracaine Hydrochloride, Sportpharm LLC, effective July 3, 2026; 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 →