FDA.reportPublic FDA data

NDC 55545-1007-2 - Dorzolamide and Timolol

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
55545-1007
Requested NDC
55545-1007-2
Package NDCs from labels
55545-1007-1, 55545-1007-2
Manufacturer
FDC Limited
Effective date
2019-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dorzolamide and Timolol - FDC LimitedFDC Limited2019-11-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1007-1Dorzolamide and Timolol1 in 1 CARTONSOLUTION11
55545-1007-1Dorzolamide and Timolol5 mL in 1 BOTTLE, PLASTICSOLUTION51
55545-1007-2Dorzolamide and Timolol10 mL in 1 BOTTLE, PLASTICSOLUTION101
55545-1007-2Dorzolamide and Timolol1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1007DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [FDC LIMITED]1Legacy NDC, 4 package rows20191116_3189b866-d8ba-4ffc-a51b-20a46ce9c361.zip

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 44 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.581f80f7-4419-49e2-867d-40443c75409f2025-03-26Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC0b41ff48-a0da-2bc6-e063-6294a90a7e982025-03-26WarningsExact identifier
unii: F5UM2KM3W7
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC0b567ef2-a782-3daa-e063-6294a90a064e2025-03-26WarningsExact identifier
unii: F5UM2KM3W7
Forticept HP Antiseptic Wound CleanserBENZALKONIUM CHLORIDE, ALLANTOINLidan, inc.41bb46ee-edce-4e1b-bcfd-5c5729e1eb152025-03-25WarningsExact identifier
unii: F5UM2KM3W7
Klean-Them Hand Sanitizing TowelsBENZALKONIUM CHLORIDERite-Kem, Inc.30dedeee-aadd-6436-e063-6394a90a0cde2025-03-21WarningsExact identifier
unii: F5UM2KM3W7
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEMY IMPORTS USA LLC304ab556-36d8-5fba-e063-6394a90a234a2025-03-19WarningsExact identifier
unii: F5UM2KM3W7
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.2f03b094-c470-d0f4-e063-6394a90a47fc2025-03-19WarningsExact identifier
unii: F5UM2KM3W7
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
unii: F5UM2KM3W7
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: F5UM2KM3W7
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
Antimicrobial Foaming HandBENZALKONIUM CHLORIDEHealth Technology Professional Products, Incdbca0970-88ca-04a4-e053-2995a90a68f22025-03-07WarningsExact identifier
unii: F5UM2KM3W7
Moxie Hand WipesBENZALKONIUM CHLORIDESkaffles Group17cd6c1a-7b31-3975-e063-6294a90a41c52025-03-07WarningsExact identifier
unii: F5UM2KM3W7
XTRABENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.27df3fce-3958-d4ea-e063-6394a90a17852025-03-06WarningsExact identifier
unii: F5UM2KM3W7
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
unii: F5UM2KM3W7
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.036dc753-1698-4c69-9bcf-752c7061203c2025-03-05Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
unii: F5UM2KM3W7
Timolol MaleateTIMOLOL MALEATEBausch & Lomb Americas Inc.9c14ca2d-80f3-48ef-b99a-beafaa728a242025-03-04Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Ben E. Keith FIHSBENZALKONIUM CHLORIDEBen E. Keith Foods4ca21370-1ecf-42c6-9c32-79cf994c336b2025-03-03WarningsExact identifier
unii: F5UM2KM3W7
Algonquin HanClean FoamBENZALKONIUM CHLORIDEWhisk Products, Inc.2f73c3a7-426e-51f4-e063-6394a90aad4f2025-03-03WarningsExact identifier
unii: F5UM2KM3W7
DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEAdvagen Pharma Ltd.ed9d1658-43cc-4c78-b3d8-e7d980a6b6732025-02-28Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7

Reported adverse events (FAERS/openFDA)#

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