Prescription medicine
Cyclopentolate Brand names: Cyclogyl
Cyclopentolate (Cyclogyl) is a prescription medicine. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $2.65 per mL (Cyclopentolate 1% eye drops) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $18.36 per mL (Cyclogyl 2% eye drops).
- Generic listed
Check it at the source: the cyclopentolate FDA label on DailyMed (effective June 25, 2024, Alcon Laboratories, Inc.); every cyclopentolate label on DailyMed.
Highlights of the record
FDA label of June 25, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Forms and strengths
- 5 mg/ml
- 10 mg/ml
- 20 mg/ml
Solution/ drops; solution.
On the market
- Generic approvals
- 10 first July 31, 1974; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.65 per mL Cyclopentolate 1% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest January 18, 2016; 1 more by firms not listed as its makers
- FAERS reports
- 645 through July 30, 2026
What is cyclopentolate used for?
From the label: indications and usageCyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Source: FDA drug label (Cyclogyl), Alcon Laboratories, Inc., effective June 25, 2024 (SPL set 1d008c76-7210-4ace-90fa-7cd22762e12e), via openFDA; the full label on DailyMed
Is there a generic for cyclopentolate (Cyclogyl)?
The FDA approved the first generic cyclopentolate on July 31, 1974. 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 cyclopentolate from 3 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.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cyclopentolate (Cyclogyl)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.65 per mL (Cyclopentolate 1% eye drops), up 10% from $2.42 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Cyclopentolate 1% eye drops (generic)
- Cyclogyl 2% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cyclopentolate 1% eye drop | Generic | $0.870 per mL | n/a | -2% |
| Cyclopentolate 1% eye drops | Generic | $2.65 per mL | n/a | +10% |
| Cyclogyl 0.5% eye drops | Brand | $6.40 per mL | n/a | -0.6% |
| Cyclogyl 2% eye drops | Brand | $18.36 per mL | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cyclopentolate been recalled?
The FDA's Enforcement Report lists 2 recalls naming cyclopentolate since 2013: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of cyclopentolate 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 |
|---|---|---|---|
| January 18, 2016 | Class III | Bausch & Lomb, Inc. | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cyclopentolate label say about other medicines?
The cyclopentolate label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbachol | drug interactions | Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. |
| Pilocarpine | drug interactions | Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. |
Source: FDA drug label (Cyclogyl), Alcon Laboratories, Inc., effective June 25, 2024 (SPL set 1d008c76-7210-4ace-90fa-7cd22762e12e), via openFDA; the full label on DailyMed
What do FAERS reports show for cyclopentolate?
The FDA Adverse Event Reporting System holds 645 reports that list cyclopentolate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 148 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?
- Cyclopentolate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other