FDA.reportPublic FDA data

NDC 63629-8612-01 - AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

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
63629-8612
Requested NDC
63629-8612-01
Package NDCs from labels
63629-8612-1, 63629-8612-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE - Bryant Ranch PrepackBryant Ranch Prepack2025-03-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8612-1AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE120 in 1 BOTTLESPRAY, METERED120104
63629-8612-1AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED1104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8612AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE) SPRAY, METERED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20250330_1a930a09-db26-40aa-bb05-123a0d7182bc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8612-1GM - Gram63629-8612fa5ca6a6-b02a-4aec-b4b9-53cce0e6eee512023-08-08

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 94 · 1,875 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
North Woods Derma Foam Hand SanitizerBENZALKONIUM CHLORIDESuperior Chemical Corporationad51a175-2b91-fd14-e053-2995a90ad54d2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDEApotex Corp.4f58c203-f649-a18e-aaf3-70b0797652f42026-09-08Warnings, Adverse reactionsExact identifier
unii: 0L591QR10I
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEApotex Corp.77a33738-ffcf-221c-1562-780418882e5d2026-09-08Warnings, Adverse reactionsExact identifier
unii: 0L591QR10I
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.1ce604aa-2535-4a3c-a64d-092f5d4f81942026-09-08Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.197b7628-71aa-4fa2-94df-d617c0f2c9862026-09-08Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Azelastine hydrochloride and Fluticasone propionateAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEApotex Corp.7bbc6514-bea3-0be0-e673-a8f6069025ff2026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 1797847
unii: O2GMZ0LF5W
unii: 0L591QR10I
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cd664e-f232-bd50-e063-6394a90ac1392026-09-07WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: F5UM2KM3W7
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
unii: F5UM2KM3W7
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
unii: F5UM2KM3W7
FluticasoneFLUTICASONE PROPIONATEYYBA CORP535b2575-8af8-d951-e063-6394a90ac72d2026-09-01WarningsExact identifier
unii: O2GMZ0LF5W

Reported adverse events (FAERS/openFDA)#

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