FDA.reportPublic FDA data

NDC 42571-382-71 - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

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
42571-382
Requested NDC
42571-382-71
Package NDCs from labels
42571-382-71, 42571-382-73, 42571-382-27
Manufacturer
Micro Labs Limited
Effective date
2026-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - Micro Labs LimitedMicro Labs Limited2026-04-30HUMAN PRESCRIPTION DRUG LABEL
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-382-27DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE12 in 1 CARTONSOLUTION/ DROPS126
42571-382-27DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE15 in 1 POUCHSOLUTION/ DROPS156
42571-382-71DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.26
42571-382-71DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE15 in 1 POUCHSOLUTION/ DROPS156
42571-382-73DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE4 in 1 CARTONSOLUTION/ DROPS46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-382DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE) SOLUTION/ DROPS [MICRO LABS LIMITED]5Current NDC, Legacy NDC, 5 package rows20241207_b0a1d984-efee-4751-9797-c09adc2d307d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-382-71EA - Each42571-3826e6978e1-9957-48ed-9189-ab5ec85a972c12022-04-06
42571-382-73EA - Each42571-3821effc12b-e81b-4521-b3b2-ae21f346ac1912022-04-06

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 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dorzolamide Hydrochloride Ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDEMicro Labs Limited4698e4e1-c5f6-4db1-9328-74464a85afea2025-01-08Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Emetrol Powder Non-DrowsySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation9d8d2ee7-9db7-4be7-8c73-511eb2e324592025-01-08WarningsExact identifier
unii: B22547B95K
Timolol MaleateTIMOLOL MALEATEA-S Medication Solutions5305a38e-d9c8-4f9e-bf67-b246abc82cb12024-12-20Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Timolol MaleateTIMOLOL MALEATEMicro Labs Limited79b223e4-d929-4667-8149-e79bfab13fdf2024-12-05Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide HClDORZOLAMIDE HCLA-S Medication Solutions91df460c-b896-4600-9d33-e499b49ba1b62024-11-11Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTIONAlembic Pharmaceuticals Limited2b1fa44a-3890-4634-bcfc-c7310b51128e2024-11-06Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTIONAlembic Pharmaceuticals Inc.6b9c446e-7068-479b-8611-aead7a8d2f502024-11-06Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.b686bbad-1ef7-4b94-a316-4d182a40b89a2024-11-04Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEA-S Medication Solutions8cdf22c8-75ca-404e-b354-9e254690d0e72024-11-01Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATESomerset Therapeutics, LLCe797f7c7-0588-4627-b060-8df6bcfe3f7b2024-10-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R

Reported adverse events (FAERS/openFDA)#

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