FDA.reportPublic FDA data

NDC 0363-0653-01 - Azelastine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0363-0653
Requested NDC
0363-0653-01
Package NDCs from labels
0363-0653-01, 0363-0653-03, 0363-0653-02, 0363-0653-04, 0363-0653-05
Manufacturer
Walgreens
Effective date
2026-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azelastine Hydrochloride - WalgreensWalgreens2026-04-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0653-01Azelastine Hydrochloride60 in 1 BOTTLE, SPRAYSPRAY, METERED606
0363-0653-02Azelastine Hydrochloride120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
0363-0653-03Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED16
0363-0653-04Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED16
0363-0653-05Azelastine Hydrochloride120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
0363-0653-05Azelastine Hydrochloride2 in 1 CARTONSPRAY, METERED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0653AZELASTINE HYDROCHLORIDE SPRAY, METERED [WALGREENS]2Current NDC, 6 package rows20250330_ec268981-433f-b26b-4ff0-3a121e0a0d08.zip

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 4 of 71 · 1,420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoono Hand SanitizerBENZALKONIUM CHLORIDEZoono Holdings USAb48c9a16-5027-1fdb-e053-2a95a90a54892026-07-31WarningsExact identifier
unii: F5UM2KM3W7
Zoono Wound CleanserBENZALKONIUM CHLORIDEZoono Holdings USA LLC41fae81e-a2f5-1c07-e054-00144ff8d46c2026-07-31WarningsExact identifier
unii: F5UM2KM3W7
Zoono Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEZoono Holdings USA LLCb4dcfd0f-e3b6-a7e9-e053-2a95a90a56c82026-07-31WarningsExact identifier
unii: F5UM2KM3W7
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BIOPURE50CT ANTI BACTERIAL HAND WIPESBIOPURE50CT ANTI BACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd57d3e290-1343-4075-e063-6394a90a41a62026-07-30WarningsExact identifier
unii: F5UM2KM3W7
Jelly SmackBENZALKONIUM CHLORIDEVULCAN MICROBIAL CORPORATIONeb79e11a-6c29-556b-e053-2a95a90a728a2026-07-29WarningsExact identifier
unii: F5UM2KM3W7
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: F5UM2KM3W7
AEROAIDBENZALKONIUM CHLORIDEAero Healthcare US LLCc9d55d86-0a4e-4c44-96e8-8d13fd16c54d2026-07-24WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
unii: F5UM2KM3W7
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEYYBA Corp52f67910-11a7-6e7d-e063-6394a90ac9e82026-07-22WarningsExact identifier
rxcui: 1797883
unii: 0L591QR10I
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Germfree24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfb43545b-6ddc-49fb-86dd-17cd1a925a782026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Pharma-Care Skin Preparation ClothsBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc324ec648-59f9-46c2-ab7a-7ec6ba42dd422026-07-22WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc0c73f042-47e5-4eba-ba59-52aabf8f45312026-07-22WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc91655320-7d8e-4024-b8f3-511d33d059f92026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Germ-Free 24 SanitizingBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc1ef9c150-f885-4b0e-8b69-82c4832fab912026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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