warnings
Warnings For external use only Do Not Use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation
Zaditor
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
- Zaditor
- Generic name
- KETOTIFEN FUMARATE
- Manufacturer
- Alcon Laboratories, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
- SPL ID
- bed738a0-2943-46e7-a65e-2440dac7971b
- Version
- 13
- Effective date
- 2023-12-15
- Source export date
- 2026-11-06
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:43:14
| 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 | 077200 | derived:openfda.application_number |
| application number | ANDA077200 | openfda.application_number | |
| brand name | Zaditor | openfda.brand_name | |
| generic name | KETOTIFEN FUMARATE | openfda.generic_name | |
| manufacturer name | Alcon Laboratories, Inc. | openfda.manufacturer_name | |
| ndc | package | 0065-4011-06 | openfda.package_ndc |
| ndc | package | 0065-4011-11 | openfda.package_ndc |
| ndc | package | 0065-4011-05 | openfda.package_ndc |
| ndc | product | 0065-4011 | openfda.product_ndc |
| ndc11 | package | 00065401111 | derived:openfda.package_ndc |
| ndc11 | package | 00065401106 | derived:openfda.package_ndc |
| ndc11 | package | 00065401105 | derived:openfda.package_ndc |
| rxcui | 284380 | openfda.rxcui | |
| rxcui | 311237 | openfda.rxcui | |
| spl id | bed738a0-2943-46e7-a65e-2440dac7971b | id | |
| spl set id | ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f | set_id | |
| unii | HBD503WORO | 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.