FDA label c9a92c4b-a806-481f-9809-8acd50f41363
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
- SPL set ID
- 8b0fde24-9549-11cf-e053-2a95a90a9338
- SPL ID
- c9a92c4b-a806-481f-9809-8acd50f41363
- Version
- 3
- Effective date
- 2024-01-09
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:57:17
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 |
|---|---|---|---|
| spl id | c9a92c4b-a806-481f-9809-8acd50f41363 | id | |
| spl set id | 8b0fde24-9549-11cf-e053-2a95a90a9338 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING: For Topical Ophthalmic Use Only. NOT FOR INJECTION. Do not touch the dropper up to lids or any surface, as this may contaminate the solution. Dapiprazole hydrochloride ophthalmic solution should not be used in the same patient more frequently than once a week.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: In controlled studies the most frequent reaction to dapiprazole was conjunctival injection lasting 20 minutes in over 80% of patients. Burning on instillation of dapiprazole hydrochloride ophthalmic solution was reported in approximately half of all patients. Reactions occurring in 10% to 40% of patients included ptosis, lid erythema, lid edema, chemosis, itching, punctate keratitis, corneal edema, browache, photophobia and headaches. Other reactions reported less frequently included dryness of eyes, tearing and blurring of vision.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.