warnings
WARNINGS Azelastine hydrochloride ophthalmic solution is for topical ophthalmic use only and not for injection or oral use.
Azelastine 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
- Azelastine Hydrochloride
- Generic name
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Fosun Pharma USA Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 8ae2aec7-329b-41bf-89d5-f189afb782ee
- SPL ID
- 4613d423-9c03-f7d0-e063-6394a90a6a9c
- Version
- 6
- Effective date
- 2025-12-16
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:43:55
| Harmonized routes |
|---|
| INTRAOCULAR |
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 | 210092 | derived:openfda.application_number |
| application number | ANDA210092 | openfda.application_number | |
| brand name | Azelastine Hydrochloride | openfda.brand_name | |
| generic name | AZELASTINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Fosun Pharma USA Inc | openfda.manufacturer_name | |
| ndc | package | 72266-141-01 | openfda.package_ndc |
| ndc | product | 72266-141 | openfda.product_ndc |
| ndc11 | package | 72266014101 | derived:openfda.package_ndc |
| rxcui | 860805 | openfda.rxcui | |
| spl id | 4613d423-9c03-f7d0-e063-6394a90a6a9c | id | |
| spl set id | 8ae2aec7-329b-41bf-89d5-f189afb782ee | set_id | |
| unii | 0L591QR10I | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild. The following events were reported in 1% to 10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied. To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.