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 5 of 71 · 1,420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCTOR INKS HAND SANITIZERBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Ince174f231-73df-464b-bd92-23222659df242026-07-21WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Sanitizing Hand WipesBENZALKONIUM CHLORIDEENVIRO SPECIALTY CHEMICALS INCea99c72e-1881-498a-a653-29bac1dab97b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Softsoap Antibacterial with Moisturizers Crisp Clean LHSBENZALKONIUM CHLORIDEColgate-Palmolive Company7e978e04-9b1a-44ef-b082-429a6a7520282026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Germ Free Topical AntisepticBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc5e004412-1797-4cbf-83e3-7001286ad1572026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers White Tea and Berry FusionBENZALKONIUM CHLORIDEColgate-Palmolive Company804d6674-bd6c-4533-89c2-8c82de92a0772026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers Fresh CitrusBENZALKONIUM CHLORIDEColgate-Palmolive Companyb1352731-9050-4e1b-a292-ab921c22160f2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Germ Free 24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfa0cb8a1-d58a-4c7a-928e-2b071d9dd3ee2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial with moisturizers Crisp CleanBENZALKONIUM CHLORIDEColgate-Palmolive Company65d4de78-fa6f-4838-8217-0e3599cc09a02026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd56dc7a8-bee3-4eca-95cf-f1b0a6e2aad22026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DrugStore Antibacterial Hand WipesBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.56b621f2-eeaf-6ff1-e063-6394a90a88292026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
unii: F5UM2KM3W7
ALTA ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAlta Sales Inc9064a1b1-dd4a-4f74-99c4-5ea93b4be2102026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Meijer Antibacterial Spring Rain HandBENZALKONIUM CHLORIDEMeijer, Inc.35bbdd67-6d15-26b6-e063-6394a90a3f962026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDENANTONG HAIYIWEI TEXTILE CO., LTD.56cd55ee-b8ba-ddb9-e063-6394a90a1edc2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
FoamyiQ Non-Alcohol Hand SanitizerFOAMYIQ NON-ALCOHOL HAND SANITIZERSpartan Chemical Companyee8a2af2-0572-19b1-e053-2995a90a23ae2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Biodegradable Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Incd4e03834-d487-9f5d-e053-2a95a90a5e282026-07-17WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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