FDA.reportPublic FDA data

NDC 60505-0589-03 - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution

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
60505-0589
Requested NDC
60505-0589-03
Package NDCs from labels
60505-0589-1, 60505-0589-2, 60505-0589-3, 60505-0589-03
Manufacturer
Apotex Corp.
Effective date
2026-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution - Apotex Corp.Apotex Corp.2026-04-23HUMAN PRESCRIPTION DRUG LABEL
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution - Bryant Ranch PrepackBryant Ranch Prepack2024-10-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0589-1Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution1 in 1 CARTONSOLUTION17
60505-0589-1Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution5 mL in 1 BOTTLE, DROPPERSOLUTION57
60505-0589-2Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution10 mL in 1 BOTTLE, DROPPERSOLUTION107
60505-0589-2Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution1 in 1 CARTONSOLUTION17
60505-0589-3Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution15 mL in 1 BOTTLE, DROPPERSOLUTION157
60505-0589-3Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution1 in 1 CARTONSOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0589BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION [APOTEX CORP.]5Current NDC, Legacy NDC, 6 package rows20240921_268c3f6b-8798-7987-3b8c-7b7f560af5d7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0589-1ML - Milliliter60505-05899186b46b-74f8-4d62-adce-8c5351d6a1ad12022-11-07
60505-0589-2ML - Milliliter60505-058950a3e78d-b768-4cac-934a-2655860aa29912022-11-07
60505-0589-3ML - Milliliter60505-058978a3ab8b-9451-407f-841a-8170ae99e24112022-11-07

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 82 · 1,636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Brimonidine TartrateBRIMONIDINE TARTRATEApotex Corp.e08a915a-77ca-4d16-d760-11b05848418d2026-09-09Warnings, Adverse reactionsExact identifier
unii: 4S9CL2DY2H
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
Brimonidine Tartrate Ophthalmic SolutionBRIMONIDINE TARTRATE OPHTHALMIC SOLUTIONLifestar Pharma LLCf6666d85-f810-4869-993d-e8ae35b4517f2026-09-03Warnings, Adverse reactionsExact identifier
unii: 4S9CL2DY2H
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions64561dfd-3704-4820-aef6-d0d26cef72552026-09-02Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
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
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
unii: F5UM2KM3W7
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Swisher Advanced Antibacterial Foam HandsoapBENZALKONIUM CHLORIDEEcolab Inc.38bd6680-db95-424c-8e84-2e12c2388a732026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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