Prescription medicine
Tropicamide Brand names: Mydriacyl
Tropicamide (Mydriacyl) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.552 per mL (Tropicamide 1% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tropicamide FDA label on DailyMed (effective September 1, 2023, Bausch & Lomb Incorporated); the NDA 12111 record on Drugs@FDA; every tropicamide label on DailyMed.
Highlights of the record
FDA label of September 1, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFor mydriasis and cycloplegia for diagnostic procedures.
Forms and strengths
- 5 mg/ml
- 10 mg/ml
Solution/ drops.
On the market
- Earliest approval on file
- February 23, 1960 Mydriacyl, Alcon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first December 6, 1974; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.552 per mL Tropicamide 1% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2016 0 Class I among all firms' recalls; latest January 18, 2016; 3 more by firms not listed as its makers
- FAERS reports
- 1,619 through July 30, 2026
What is tropicamide used for?
From the label: indications and usageFor mydriasis and cycloplegia for diagnostic procedures.
FDA pharmacologic class: Anticholinergic.
Source: FDA drug label (Tropicamide), Bausch & Lomb Incorporated, effective September 1, 2023 (SPL set 892b78c8-36bc-47d3-850e-502899b48fb9), via openFDA; the full label on DailyMed
Is there a generic for tropicamide (Mydriacyl)?
The FDA approved the first generic tropicamide on December 6, 1974. 11 generic applications are approved; 7 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 tropicamide from 5 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.
- 1960 earliest approval on file
- 1974 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 tropicamide (Mydriacyl)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.552 per mL (Tropicamide 1% eye drops), up 15% from $0.478 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.
- Tropicamide 1% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tropicamide 1% eye drop | Generic | $0.552 per mL | n/a | +15% |
| Tropicamide 1% eye drops | Generic | $0.552 per mL | n/a | +15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tropicamide been recalled?
The FDA's Enforcement Report lists 5 recalls naming tropicamide since 2016: 0 Class I (the most serious), 3 Class II, 2 Class III; 2 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of tropicamide 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 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office not a listed maker | cGMP deviations: Temperature abuse |
| January 18, 2016 | Class III | Bausch & Lomb, Inc. | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tropicamide label say about other medicines?
The tropicamide 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 Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. |
| Pilocarpine | drug interactions | Drug Interactions Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. |
Source: FDA drug label (Tropicamide), Bausch & Lomb Incorporated, effective September 1, 2023 (SPL set 892b78c8-36bc-47d3-850e-502899b48fb9), via openFDA; the full label on DailyMed
What do FAERS reports show for tropicamide?
The FDA Adverse Event Reporting System holds 1,619 reports that list tropicamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 71 are coded as a death and 410 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?
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Tropicamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other