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 (canonical bytes are SHA-256 checked before publication)

Brand name: Tropicamide
Generic name: TROPICAMIDE
Manufacturer: Bausch & Lomb Incorporated
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 892b78c8-36bc-47d3-850e-502899b48fb9
SPL ID: f7ca9591-4d7b-4c5e-b54e-e08fd8cf6755
Version: 9
Effective date: 2023-09-01
Source export date: 2026-10-27
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/29a1aba6a935d72bab5474118c2ccf25cb52dfe8488fe1593c734ea6c04e3722/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:44:44

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 20 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	040067	derived:openfda.application_number
application applno	ANDA	040064	derived:openfda.application_number
application number		ANDA040064	openfda.application_number
application number		ANDA040067	openfda.application_number
brand name		Tropicamide	openfda.brand_name
generic name		TROPICAMIDE	openfda.generic_name
manufacturer name		Bausch & Lomb Incorporated	openfda.manufacturer_name
ndc	package	24208-585-59	openfda.package_ndc
ndc	package	24208-585-64	openfda.package_ndc
ndc	package	24208-590-64	openfda.package_ndc
ndc	product	24208-590	openfda.product_ndc
ndc	product	24208-585	openfda.product_ndc
ndc11	package	24208058559	derived:openfda.package_ndc
ndc11	package	24208059064	derived:openfda.package_ndc
ndc11	package	24208058564	derived:openfda.package_ndc
rxcui		314238	openfda.rxcui
rxcui		313521	openfda.rxcui
spl id		f7ca9591-4d7b-4c5e-b54e-e08fd8cf6755	id
spl set id		892b78c8-36bc-47d3-850e-502899b48fb9	set_id
unii		N0A3Z5XTC6	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 reaction and behavioral disturbance 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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Ocular Transient stinging, blurred vision, photophobia and superficial punctate 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.