Home FDA labels 8b448d2e-0bf3-1a1a-fa2e-808a020c2692 FDA label 8b448d2e-0bf3-1a1a-fa2e-808a020c2692 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)
SPL set ID 3537dd95-954c-459f-97a9-54a861bed265
SPL ID 8b448d2e-0bf3-1a1a-fa2e-808a020c2692
Version 2
Effective date 2006-08-28
Source export date 2026-10-12
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 03:00:40
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 · 2 matching rows.
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Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Acute ocular irritation including burning, corneal stippling, vascularization, and clouding has been reported. Following prolonged use of idoxuridine, ocular irritation characterized by follicular conjunctivitis, blepharitis with punctal swelling, bulbar conjunctival hyperemia, and corneal epithelial staining has also been reported. In either case, the drug should be discontinued.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.