warnings
WARNINGS Olopatadine hydrochloride ophthalmic solution USP, 0.1% is for topical use only and not for injection or oral use.
OLOPATADINE HYDROCHLORIDE
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
- Generic name
- OLOPATADINE HYDROCHLORIDE
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 7b36e554-d68a-47e0-bf3c-f4cfdc3746b6
- SPL ID
- fc73fdb0-aa8b-4b81-998e-b1739c93047e
- Version
- 3
- Effective date
- 2019-02-21
- Source export date
- 2026-09-28
- 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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:35:36
| 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 | 209919 | derived:openfda.application_number |
| application number | ANDA209919 | openfda.application_number | |
| brand name | OLOPATADINE HYDROCHLORIDE | openfda.brand_name | |
| generic name | OLOPATADINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Alembic Pharmaceuticals Inc. | openfda.manufacturer_name | |
| ndc | package | 62332-501-05 | openfda.package_ndc |
| ndc | product | 62332-501 | openfda.product_ndc |
| ndc11 | package | 62332050105 | derived:openfda.package_ndc |
| rxcui | 1111339 | openfda.rxcui | |
| spl id | fc73fdb0-aa8b-4b81-998e-b1739c93047e | id | |
| spl set id | 7b36e554-d68a-47e0-bf3c-f4cfdc3746b6 | set_id | |
| unii | 2XG66W44KF | openfda.unii |
Warnings cross-check#
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Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritis, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.