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
- 56d4b17c-bc5d-0734-32c9-bb10ec77f7b4
- SPL ID
- 69a4a96f-dad6-28a7-1dc2-985ccdc80e36
- Version
- 2
- Effective date
- 2025-12-12
- Source export date
- 2026-10-27
- 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/2026-10-27/2eee27992d1f29d82f827fd5be42f1314ed39ce4c497af5d81435ac6656a0957/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:23:39
| 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 | 83324-120-25 | openfda.package_ndc |
| ndc | product | 83324-120 | openfda.product_ndc |
| ndc11 | package | 83324012025 | derived:openfda.package_ndc |
| rxcui | 1111343 | openfda.rxcui | |
| spl id | 69a4a96f-dad6-28a7-1dc2-985ccdc80e36 | id | |
| spl set id | 56d4b17c-bc5d-0734-32c9-bb10ec77f7b4 | 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.