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
- Gland Pharma Limited
- Product type
- HUMAN OTC DRUG
- SPL set ID
- a3475f8c-c780-43c0-b22f-08a0ce5608fd
- SPL ID
- e05ea1df-8db8-4261-be59-8f303da3b57e
- Version
- 2
- Effective date
- 2026-01-07
- Source export date
- 2026-09-28
- 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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:14:55
| 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 | 213514 | derived:openfda.application_number |
| application number | ANDA213514 | openfda.application_number | |
| brand name | Olopatadine Hydrochloride Ophthalmic Solution | openfda.brand_name | |
| generic name | OLOPATADINE HYDROCHLORIDE OPHTHALMIC | openfda.generic_name | |
| manufacturer name | Gland Pharma Limited | openfda.manufacturer_name | |
| ndc | package | 68083-398-01 | openfda.package_ndc |
| ndc | product | 68083-398 | openfda.product_ndc |
| ndc11 | package | 68083039801 | derived:openfda.package_ndc |
| rxcui | 1601086 | openfda.rxcui | |
| spl id | e05ea1df-8db8-4261-be59-8f303da3b57e | id | |
| spl set id | a3475f8c-c780-43c0-b22f-08a0ce5608fd | 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.