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
- f6d70b01-941b-b796-ceee-7f24b6038e7d
- SPL ID
- e9018310-14d0-1f1e-7bc1-c5ba9d88696b
- Version
- 3
- Effective date
- 2025-12-12
- Source export date
- 2026-10-12
- 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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:27:37
| 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 | 209752 | derived:openfda.application_number |
| application number | ANDA209752 | 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 | 63868-821-25 | openfda.package_ndc |
| ndc | product | 63868-821 | openfda.product_ndc |
| ndc11 | package | 63868082125 | derived:openfda.package_ndc |
| rxcui | 1111343 | openfda.rxcui | |
| spl id | e9018310-14d0-1f1e-7bc1-c5ba9d88696b | id | |
| spl set id | f6d70b01-941b-b796-ceee-7f24b6038e7d | 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.