Tropicamide
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Tropicamide
- Generic name
- TROPICAMIDE
- Manufacturer
- Sportpharm LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- fc62f539-6478-4740-98ed-5e27fcfa794e
- SPL ID
- 4a2ba794-da99-91aa-e063-6394a90a8370
- Version
- 2
- Effective date
- 2026-02-06
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:29:20
| Harmonized routes |
|---|
| OPHTHALMIC |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 207524 | derived:openfda.application_number |
| application number | ANDA207524 | openfda.application_number | |
| brand name | Tropicamide | openfda.brand_name | |
| generic name | TROPICAMIDE | openfda.generic_name | |
| manufacturer name | Sportpharm LLC | openfda.manufacturer_name | |
| ndc | package | 85766-040-15 | openfda.package_ndc |
| ndc | product | 85766-040 | openfda.product_ndc |
| ndc11 | package | 85766004015 | derived:openfda.package_ndc |
| rxcui | 314238 | openfda.rxcui | |
| spl id | 4a2ba794-da99-91aa-e063-6394a90a8370 | id | |
| spl set id | fc62f539-6478-4740-98ed-5e27fcfa794e | set_id | |
| unii | N0A3Z5XTC6 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS 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 cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.