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 8 of 71 · 1,420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
unii: F5UM2KM3W7
Foaming Antibacterial HandBENZALKONIUM CHLORIDEIntercon Chemical Company556b74d3-d37d-9508-e063-6294a90ae89f2026-06-29WarningsExact identifier
unii: F5UM2KM3W7
PURELL SF607 Instant Hand SanitizingBENZALKONIUM CHLORIDEGOJO Industries, Inc.f29dcf99-9b5d-46f5-ac15-fd9c2f2318f42026-06-25WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)BENZALKONIUM CHLORIDEEleeo Brands LLC551baf59-39b9-e994-e063-6294a90a65e62026-06-25WarningsExact identifier
unii: F5UM2KM3W7
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 506T60A25R
MOUTAIN DEW HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fbbdde-ef7b-0a8b-e063-6294a90ad9e42026-06-24WarningsExact identifier
unii: F5UM2KM3W7
BAJA BLAST HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fc7e91-53f7-70b4-e063-6294a90ac0852026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY SEA SALT CARAMEL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fce390-6b53-f9f7-e063-6294a90aa44f2026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY CHERRY CRUSH HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0c49-bf20-c2e3-e063-6294a90a56402026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY VANILLA CUPCAKE HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0885-0d8c-614d-e063-6394a90acef92026-06-24WarningsExact identifier
unii: F5UM2KM3W7
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 1Q73Q2JULR
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MISTIFY SWEET STRAWBERRY HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd55042fdb-ce19-2396-e063-6394a90a99862026-06-24WarningsExact identifier
unii: F5UM2KM3W7
VANILL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54e9d23b-45e5-5e53-e063-6394a90a60662026-06-23WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.3ca0168d-8945-907a-e063-6294a90a9deb2026-06-23WarningsExact identifier
unii: F5UM2KM3W7
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.54def395-2f22-20a4-e063-6294a90a61962026-06-22WarningsExact identifier
unii: F5UM2KM3W7
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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