Quick answers
- What is Proparacaine hydrochloride used for?
- The FDA-approved label (Alcaine, Alcon Laboratories, Inc., June 10, 2026) says: “ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Proparacaine hydrochloride have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Proparacaine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Proparacaine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 11, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Proparacaine hydrochloride?
- 10 companies list prescription products of Proparacaine hydrochloride in the FDA NDC Directory, including Sportpharm LLC, NuCare Pharmaceuticals, Inc. and Bausch & Lomb Incorporated.
What Proparacaine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
— FDA label: Alcaine, Alcon Laboratories, Inc., effective June 10, 2026. Read the full label on DailyMed →
The FDA has 13 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 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Alcaine |
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 |
|---|---|---|
| proparacaine hydrochloride 5 mg/mL solution/ drops | Generic | $1.42 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 LLC3 products
- NuCare Pharmaceuticals, Inc.2 products
- Bausch & Lomb Incorporated1 product
- Micro Labs Limited1 product
- Sandoz Inc1 product
- Alcon Laboratories, Inc.1 product
- Remedyrepack Inc.1 product
- Lifestar Pharma LLC1 product
- A-S Medication Solutions1 product
- Somerset Therapeutics, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA080027Alcon Labs Inc · December 22, 1971
- ANDA040074Bausch and Lomb Inc · September 29, 1995
- ANDA215816Somerset Theraps LLC · August 9, 2024
- ANDA219136Mankind Pharma · May 21, 2025
- ANDA219294Micro Labs · October 20, 2025
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.
-
September 11, 2024 · Class II · Terminated · D-0661-2024
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06 — 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) | 1191013, 1191026 |
|---|---|
| SPL set ID of the quoted label | 0c0fa0bf-977d-4539-b8dc-54c187c5b094 |
| FDA labels (SPL) | 13 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | PROPARACAINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Alcaine, Alcon Laboratories, Inc., effective June 10, 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 →