warnings
Warnings For external use only
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
- GLENMARK THERAPEUTICS INC., USA
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 07e8b359-d4ae-4b5b-81dc-c7e57e172c58
- SPL ID
- 5ce14b14-b893-4d56-a19e-b1788b17074f
- Version
- 3
- Effective date
- 2026-01-27
- Source export date
- 2026-10-12
- 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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:13:13
| 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 | 219557 | derived:openfda.application_number |
| application number | ANDA219557 | openfda.application_number | |
| brand name | OLOPATADINE HYDROCHLORIDE | openfda.brand_name | |
| generic name | OLOPATADINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | GLENMARK THERAPEUTICS INC., USA | openfda.manufacturer_name | |
| ndc | package | 72657-194-11 | openfda.package_ndc |
| ndc | package | 72657-194-25 | openfda.package_ndc |
| ndc | product | 72657-194 | openfda.product_ndc |
| ndc11 | package | 72657019411 | derived:openfda.package_ndc |
| ndc11 | package | 72657019425 | derived:openfda.package_ndc |
| rxcui | 1111343 | openfda.rxcui | |
| spl id | 5ce14b14-b893-4d56-a19e-b1788b17074f | id | |
| spl set id | 07e8b359-d4ae-4b5b-81dc-c7e57e172c58 | 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.