Prescription medicine
Proparacaine Brand names: Alcaine; first approved as Ophthaine
Proparacaine (Alcaine) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $1.47 per mL (Proparacaine 0.5% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the proparacaine FDA label on DailyMed (effective June 10, 2026, Alcon Laboratories, Inc.); the NDA 8883 record on Drugs@FDA; every proparacaine label on DailyMed.
Highlights of the record
FDA label of June 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g.
Forms and strengths
- 5 mg/ml
Solution/ drops.
On the market
- Earliest approval on file
- July 1, 1953 Ophthaine, Apothecon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first December 22, 1971; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.47 per mL Proparacaine 0.5% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2019 0 Class I among all firms' recalls; latest September 11, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 527 through July 30, 2026
What is proparacaine used for?
From the label: indications and usageALCAINE™ 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 pharmacologic class: Local Anesthetic.
Source: FDA drug label (Alcaine), Alcon Laboratories, Inc., effective June 10, 2026 (SPL set 0c0fa0bf-977d-4539-b8dc-54c187c5b094), via openFDA; the full label on DailyMed
Is there a generic for proparacaine (Alcaine)?
The FDA approved the first generic proparacaine on December 22, 1971. 10 generic applications are approved; 6 of them carry 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 proparacaine from 10 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1953 earliest approval on file
- 1971 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 proparacaine (Alcaine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.47 per mL (Proparacaine 0.5% eye drops), down 14% from $1.70 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.
- Proparacaine 0.5% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Proparacaine 0.5% eye drops | Generic | $1.47 per mL | n/a | -14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has proparacaine been recalled?
The FDA's Enforcement Report lists 5 recalls naming proparacaine since 2019: 0 Class I (the most serious), 4 Class II, 1 Class III; 3 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of proparacaine and that holds 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 |
|---|---|---|---|
| September 11, 2024 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | Temperature abuse: Products exposed to improper temperature above drug label specifications. |
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
| December 26, 2019 | Class III | Akorn, Inc. | Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for proparacaine?
The FDA Adverse Event Reporting System holds 527 reports that list proparacaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 35 are coded as a death and 132 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Proparacaine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other