Prescription medicine
Acetylcholine Brand names: Miochol
Acetylcholine (Miochol) is a prescription medicine with an FDA approval on record since 1973. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the acetylcholine FDA label on DailyMed (effective March 17, 2023, Bausch & Lomb Incorporated); the NDA 16211 record on Drugs@FDA; every acetylcholine label on DailyMed.
Highlights of the record
FDA label of March 17, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTo obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- October 9, 1973 Miochol, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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)
- 1 since 2022 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 92 through July 30, 2026
What is acetylcholine used for?
From the label: indications and usageTo obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required.
Source: FDA drug label (Miochol E), Bausch & Lomb Incorporated, effective March 17, 2023 (SPL set e701ef07-9499-4b56-931f-f4eb3eedbe24), via openFDA; the full label on DailyMed
Is there a generic for acetylcholine (Miochol)?
No generic acetylcholine is approved (Drugs@FDA, October 8, 2026).
- 1973 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has acetylcholine been recalled?
The FDA's Enforcement Report lists 1 recall naming acetylcholine since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for acetylcholine?
The FDA Adverse Event Reporting System holds 92 reports that list acetylcholine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 44 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?
- Acetylcholine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other