Prescription medicine
Cyclopentolate and phenylephrine Brand names: Cyclomydril
Cyclopentolate and phenylephrine (Cyclomydril) is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the cyclopentolate and phenylephrine FDA label on DailyMed (effective May 15, 2025, Alcon Laboratories, Inc.); every cyclopentolate and phenylephrine label on DailyMed.
Highlights of the record
FDA label of May 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFor the production of mydriasis.
Forms and strengths
- 2 mg/ml / 10 mg/ml
Solution/ drops.
On the market
- Generic approvals
- 1 first September 12, 1975; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 68 through July 30, 2026
What is cyclopentolate and phenylephrine used for?
From the label: indications and usageFor the production of mydriasis.
FDA pharmacologic class: alpha-1 Adrenergic Agonist.
Source: FDA drug label (Cyclomydril), Alcon Laboratories, Inc., effective May 15, 2025 (SPL set 8268b70f-3f10-48dd-bb24-baaeb27a1325), via openFDA; the full label on DailyMed
Is there a generic for cyclopentolate and phenylephrine (Cyclomydril)?
The FDA approved the first generic cyclopentolate and phenylephrine on September 12, 1975. 1 generic application is approved; 1 of it carries 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 and phenylephrine from 1 labeler 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 FAERS reports show for cyclopentolate and phenylephrine?
The FDA Adverse Event Reporting System holds 68 reports that list cyclopentolate and phenylephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 7 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other alpha-1 adrenergic agonists
- the pharmacologic class, with prices and generics
- Cyclopentolate and phenylephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other