FDA.reportPublic FDA data

NDC 82584-604-01 - COSOPT PF

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
82584-604
Requested NDC
82584-604-01
Package NDCs from labels
82584-604-01, 82584-604-30
Manufacturer
Thea Pharma Inc.
Effective date
2026-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COSOPT PF - Thea Pharma Inc.Thea Pharma Inc.2026-05-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82584-604-01COSOPT PF0.2 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.25
82584-604-01COSOPT PF15 in 1 POUCHSOLUTION/ DROPS155
82584-604-30COSOPT PF4 in 1 CARTONSOLUTION/ DROPS45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-604COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [THEA PHARMA INC.]4Current NDC, Legacy NDC, 3 package rows20240110_535fc801-8c3f-4974-a120-3eff1d5a5062.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82584-604-01EA - Each82584-6041022a67e-181f-42ea-998c-9d41a6c06e8312023-03-13
82584-604-30EA - Each82584-60496b6f821-1bdf-4dde-9814-b7b57e23220012023-01-09

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 7 of 15 · 293 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 1Q73Q2JULR
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEGland Pharma Limited2023e603-12bb-4502-9f93-0126e0cc24ed2025-05-10Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%Alembic Pharmaceuticals Inc.b909ecf0-c90a-4719-a144-9e74f457cb872025-04-25Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%Alembic Pharmaceuticals Limited9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e2025-04-25Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.581f80f7-4419-49e2-867d-40443c75409f2025-03-26Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 1Q73Q2JULR
Brimonidine Tartrate/Timolol Maleate Ophthalmic SolutionBRIMONIDINE TARTRATE AND TIMOLOL MALEATECaplin Steriles Limitedeac3cec2-b373-4936-89f0-c6d300e09f6e2025-03-10Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.036dc753-1698-4c69-9bcf-752c7061203c2025-03-05Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.9c14ca2d-80f3-48ef-b99a-beafaa728a242025-03-04Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEAdvagen Pharma Ltd.ed9d1658-43cc-4c78-b3d8-e7d980a6b6732025-02-28Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDESomerset Therapeutics, LLC0832960f-0a6f-4fd1-bf55-be9bebde53bd2025-02-12Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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