On this page
Mydriacyl
tropicamide · Solution/ Drops
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Tropicamide | 10 mg/mL | 314238 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anticholinergic [EPC] | EPC | All 41 members |
| Cholinergic Antagonists [MoA] | MoA | All 41 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 084306-001 | MYDRIACYL | SOLUTION/DROPS | TROPICAMIDE | Prescription | AT | RLD RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 35 | Labeling | Approved | October 31, 2003 | — |
| Supplement | 34 | Manufacturing (CMC) | Approved | December 23, 2002 | — |
| Supplement | 32 | Manufacturing (CMC) | Approved | March 20, 2001 | — |
| Supplement | 31 | Manufacturing (CMC) | Approved | March 20, 2001 | — |
| Supplement | 27 | Manufacturing (CMC) | Approved | October 11, 2000 | — |
| Supplement | 30 | Manufacturing (CMC) | Approved | April 28, 2000 | — |
| Supplement | 33 | Manufacturing (CMC) | Approved | April 7, 2000 | — |
| Supplement | 25 | Manufacturing (CMC) | Approved | May 7, 1999 | — |
| Supplement | 28 | Manufacturing (CMC) | Approved | April 21, 1999 | — |
| Supplement | 26 | Manufacturing (CMC) | Approved | March 23, 1999 | — |
| Supplement | 24 | Manufacturing (CMC) | Approved | March 4, 1999 | — |
| Supplement | 23 | Manufacturing (CMC) | Approved | September 25, 1998 | — |
| Supplement | 16 | Labeling | Approved | February 7, 1997 | — |
| Supplement | 22 | Manufacturing (CMC) | Approved | January 22, 1997 | — |
| Supplement | 21 | Manufacturing (CMC) | Approved | October 5, 1995 | — |
| Supplement | 20 | Manufacturing (CMC) | Approved | August 4, 1995 | — |
| Supplement | 19 | Labeling | Approved | September 14, 1993 | — |
| Supplement | 17 | Manufacturing (CMC) | Approved | June 4, 1993 | — |
| Supplement | 15 | Manufacturing (CMC) | Approved | June 4, 1993 | — |
| Supplement | 18 | Manufacturing (CMC) | Approved | November 5, 1992 | — |
| Supplement | 14 | Labeling | Approved | May 9, 1989 | — |
| Supplement | 13 | Manufacturing (CMC) | Approved | April 26, 1989 | — |
| Supplement | 8 | Manufacturing (CMC) | Approved | May 3, 1985 | — |
| Supplement | 7 | Manufacturing (CMC) | Approved | May 3, 1985 | — |
| Supplement | 10 | Manufacturing (CMC) | Approved | January 13, 1984 | — |
| Original application | 1 | Approved | December 6, 1974 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230215). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any component of this preparation.
Warnings
openFDA Drug LabelingWARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered. Mydriatics may produce a transient elevation of intraocular pressure. Remove contact lenses before using.
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctuate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
Drug Interactions
openFDA Drug LabelingDrug Interactions Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Description
openFDA Drug LabelingDESCRIPTION MYDRIACYL ® (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure: Each mL of MYDRIACYL ® (tropicamide ophthalmic solution, USP) contains: Active: tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water; pH range 4.0-5.8. chemical
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED 3 mL and 15 mL in plastic DROP-TAINER® dispensers. 0.5% 15 mL: NDC 0998-0354-15 1% 3 mL: NDC 0065-0355-03 15 mL: NDC 0998-0355-15 STORAGE: Store at 8°C to 27°C (46°F-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. Rx Only
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TROPICAMIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 0065-0355-03 | 0065-0355 | Alcon Laboratories, Inc. | 1 BOTTLE in 1 CARTON (0065-0355-03) / 3 mL in 1 BOTTLE | April 1, 1959 |
| 0998-0355-15 | 0998-0355 | Alcon Laboratories, Inc. | 1 BOTTLE in 1 CARTON (0998-0355-15) / 15 mL in 1 BOTTLE | April 1, 1959 |
| 0065-0355 | 0065-0355 | Alcon Laboratories, Inc. | — | April 1, 1959 |
| 0998-0355 | 0998-0355 | Alcon Laboratories, Inc. | — | April 1, 1959 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.