warnings
WARNINGS For external use only
Olopatadine Hydrochloride Ophthalmic Solution Twice Daily
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 Twice Daily
- Generic name
- OLOPATADINE HYDROCHLORIDE OPHTHALMIC
- Manufacturer
- DOLGENCORP, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- a9f03242-b5fa-5762-f9a6-b7c0c5ee46c3
- SPL ID
- fb7ff287-49de-f4ae-11fd-1b7726814156
- Version
- 2
- Effective date
- 2021-06-29
- 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 03:07:47
| 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 Twice Daily | openfda.brand_name | |
| generic name | OLOPATADINE HYDROCHLORIDE OPHTHALMIC | openfda.generic_name | |
| manufacturer name | DOLGENCORP, LLC | openfda.manufacturer_name | |
| ndc | package | 55910-109-05 | openfda.package_ndc |
| ndc | product | 55910-109 | openfda.product_ndc |
| ndc11 | package | 55910010905 | derived:openfda.package_ndc |
| rxcui | 1111339 | openfda.rxcui | |
| spl id | fb7ff287-49de-f4ae-11fd-1b7726814156 | id | |
| spl set id | a9f03242-b5fa-5762-f9a6-b7c0c5ee46c3 | 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.