warnings
WARNINGS For external use only
Olopatadine Hydrochloride Ophthalmic Solution
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
- Olopatadine Hydrochloride Ophthalmic Solution
- Generic name
- OLOPATADINE HYDROCHLORIDE OPHTHALMIC
- Manufacturer
- Chain Drug Marketing Association INC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 5fa34b50-ffa3-4090-86f9-436f32f45cea
- SPL ID
- 8a32aa43-e0cf-f950-04b1-2a30384d2674
- Version
- 3
- Effective date
- 2025-12-10
- Source export date
- 2026-11-06
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/9d5577a314a25811fefbde4767c9b37f3913d9a65fdc458c6336b5aed532339e/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
- Import run
- 20261106T075659Z
- Imported at
- 2026-11-06 08:50:27
| 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 | 209619 | derived:openfda.application_number |
| application number | ANDA209619 | openfda.application_number | |
| brand name | Olopatadine Hydrochloride Ophthalmic Solution | openfda.brand_name | |
| generic name | OLOPATADINE HYDROCHLORIDE OPHTHALMIC | openfda.generic_name | |
| manufacturer name | Chain Drug Marketing Association INC | openfda.manufacturer_name | |
| ndc | package | 63868-822-05 | openfda.package_ndc |
| ndc | product | 63868-822 | openfda.product_ndc |
| ndc11 | package | 63868082205 | derived:openfda.package_ndc |
| rxcui | 1111339 | openfda.rxcui | |
| spl id | 8a32aa43-e0cf-f950-04b1-2a30384d2674 | id | |
| spl set id | 5fa34b50-ffa3-4090-86f9-436f32f45cea | set_id | |
| unii | 2XG66W44KF | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.