FDA.reportPublic FDA data

NDC 69238-2147-03 - Azelastine HCl

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
69238-2147
Requested NDC
69238-2147-03
Package NDCs from labels
69238-2147-3, 69238-2147-03
Manufacturer
Amneal Pharmaceuticals NY LLC
Effective date
2025-11-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azelastine HCl - Amneal Pharmaceuticals NY LLCAmneal Pharmaceuticals NY LLC2025-11-03HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2147-3Azelastine HCl1 in 1 CARTONSPRAY, METERED110
69238-2147-3Azelastine HCl200 in 1 BOTTLESPRAY, METERED20010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2147AZELASTINE HCL (AZELASTINE) SPRAY, METERED [AMNEAL PHARMACEUTICALS NY LLC]9Current NDC, 2 package rows20240608_82610437-25f4-4ae0-9d6a-381e9932f87d.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 9 of 73 · 1,451 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
unii: F5UM2KM3W7
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
unii: F5UM2KM3W7
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEWildman Business Group1fd15b91-6b81-d0bd-e063-6294a90a4d272026-06-15WarningsExact identifier
unii: F5UM2KM3W7
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDENINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.540bde3c-5af2-456a-e063-6294a90aa7742026-06-12WarningsExact identifier
unii: F5UM2KM3W7
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
AntibacterialBENZALKONIUM CHLORIDERubbermaid Commercial Products LLC6023285c-6b02-410e-9492-df0543279f252026-06-11WarningsExact identifier
unii: F5UM2KM3W7
Walgreens Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEWalgreen Company43c66c66-4e5f-4d02-82ec-66260adbef042026-06-11WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.53ea8cec-bf36-4eec-e063-6394a90a559c2026-06-10WarningsExact identifier
unii: F5UM2KM3W7
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Antibacterial Hand WashBENZALKONIUM CHLORIDERubbermaid Commercial Products LLCb71ba5ce-096e-4d56-831f-a2d208157ab72026-06-08WarningsExact identifier
unii: F5UM2KM3W7
Enriched Foam Alcohol-Free Hand SanitizerBENZALKONIUM CHLORIDERubbermaid Commercial Products LLC0a6456aa-69f7-476b-afbb-3dd69377e8b22026-06-05WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Foaming HandBENZALKONIUM CHLORIDECintas765ae77c-e48b-4996-82d1-cec8ed7c846f2026-06-05WarningsExact identifier
unii: F5UM2KM3W7
Diamond Wipes Antibacterial Hand WipesBENZALKONIUM CHLORIDEDiamond Wipes International Inc.1809b3cf-db76-83db-e063-6294a90a36812026-06-04WarningsExact identifier
unii: F5UM2KM3W7
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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