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 2 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide Hydrochloride OphthalmicDORZOLAMIDE HYDROCHLORIDE OPHTHALMICFlorida Pharmaceutical Products, LLCe4e6a5a8-f7be-4424-83f2-d6bb4d57443e2026-06-24Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate and Timolol maleate Ophthalmic SolutionBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGland Pharma Limited038cf2ba-ad08-4981-a3cc-bff0e4ba5dfb2026-06-16Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: B22547B95K
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
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepack09dbed18-9076-4891-93a7-d14bb22179262026-06-12Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC02d89d37-cbca-4e06-83ef-2a10f988f1ea2026-06-12Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
BRIMONIDINE TARTRATE AND TIMOLOL MALEATEBRIMONIDINE TARTRATE AND TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC7011a203-46cf-434d-ba11-253f107ff80f2026-05-27Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: B22547B95K
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
COSOPT PFDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEThea Pharma Inc.535fc801-8c3f-4974-a120-3eff1d5a50622026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 1922783
unii: QZO5366EW7
unii: P8Y54F701R
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate/Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGlenmark Pharmaceuticals Inc., USAbf6a7f59-5a10-49fe-9e57-19e3ba2029182026-05-06Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepackff76c0cf-256c-4015-94f4-405f0c46205f2026-05-01Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R

Reported adverse events (FAERS/openFDA)#

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