FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2026-01-26
Label type
Indexing - product concept
Version
3
Source
full-release
Hydrated at
2026-06-05 00:26:41

Label at a glance#

ProductAZELASTINE HYDROCHLORIDE
Active ingredientAZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
AZELASTINE HYDROCHLORIDE0L591QR10IACTIB
FLUTICASONE PROPIONATEO2GMZ0LF5WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEApotex Corp.4f58c203-f649-a18e-aaf3-70b0797652f42026-09-08Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEApotex Corp.77a33738-ffcf-221c-1562-780418882e5d2026-09-08Warnings, Adverse reactionsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAurohealth LLC7281c597-651e-4425-8208-7637cd9d35002026-08-20WarningsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEYYBA Corp52f67910-11a7-6e7d-e063-6394a90ac9e82026-07-22WarningsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEWalgreensec268981-433f-b26b-4ff0-3a121e0a0d082026-04-16WarningsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.37c40f8d-269c-4df8-8ac7-cbe78f4ca5c42026-03-11Warnings, Adverse reactionsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINEAvKAREbca75501-4140-4d77-e053-2a95a90a019f2026-01-14Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEFosun Pharma USA Inc8ae2aec7-329b-41bf-89d5-f189afb782ee2025-12-16Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDESandoz Inc6945fb86-27fb-4bab-8908-98772c6269c52025-12-11Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a2ba9c1d-b21f-4816-bbe6-949a49e385722025-11-17Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEA-S Medication Solutions02257284-4bb1-4fe6-8134-e5a67a6451142025-11-06Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEGland Pharma Limitedf358cecd-284f-4d0b-806c-039465220bd22025-10-22Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDESomerset Therapeutics, LLC72406ded-7886-41fb-b5c8-2d27a149aa342025-09-26Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAllegiant Healthcc7ddac6-95fa-4bc0-824d-f80e404e8d322025-05-02WarningsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAllegiant Health3e2fdb0d-c2f5-41ab-b1cd-4fae806481122025-05-02WarningsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDENorthStar Rx LLCcb0aca6d-ff9c-4239-8681-d212a6764ba92025-04-08Warnings, Adverse reactionsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAlembic Pharmaceuticals Limited753d7a69-b0da-4350-9dc5-97f26ebe5cc02025-01-02Warnings, Adverse reactionsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEA-S Medication Solutionsfc9d031d-428d-4d53-8e63-feb96d5ab01a2024-11-20Warnings, Adverse reactionsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAurobindo Pharma Limited97c91a09-98d0-4666-8448-0bd50c02bb142024-05-16Warnings, Adverse reactionsName fallback
brand name: AZELASTINE HYDROCHLORIDE
generic name: AZELASTINE HYDROCHLORIDE
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEProficient Rx LP11a74cae-a15b-4a6b-a8c0-1e6a234ee2582023-10-01Warnings, Adverse reactionsName fallback
brand name: Azelastine Hydrochloride
generic name: AZELASTINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.