warnings
WARNINGS: Azelastine hydrochloride ophthalmic solution, 0.05% is for ocular 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
- Somerset Therapeutics, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 72406ded-7886-41fb-b5c8-2d27a149aa34
- SPL ID
- 9d82b566-97da-4162-a649-b44f3e516d9a
- Version
- 7
- Effective date
- 2025-09-26
- Source export date
- 2026-10-12
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:38:24
| 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 | 207411 | derived:openfda.application_number |
| application number | ANDA207411 | openfda.application_number | |
| brand name | Azelastine Hydrochloride | openfda.brand_name | |
| generic name | AZELASTINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Somerset Therapeutics, LLC | openfda.manufacturer_name | |
| ndc | package | 70069-091-01 | openfda.package_ndc |
| ndc | product | 70069-091 | openfda.product_ndc |
| ndc11 | package | 70069009101 | derived:openfda.package_ndc |
| rxcui | 860805 | openfda.rxcui | |
| spl id | 9d82b566-97da-4162-a649-b44f3e516d9a | id | |
| spl set id | 72406ded-7886-41fb-b5c8-2d27a149aa34 | 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 1–10% 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.