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 72 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Relax Sanitizing Towlette Organic Lavender CalmBENZALKONIUM CHLORIDEGIOVANNI COSMETICS INC70914fc3-1ada-450d-a4eb-7db283030d5f2018-01-29WarningsExact identifier
unii: F5UM2KM3W7
Byotrol Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC09edbc17-c443-4b0d-9c28-c4b8233c4d1a2017-12-14WarningsExact identifier
unii: F5UM2KM3W7
First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies25ebf112-8ac3-4402-9a87-00e454ab7efa2017-11-30WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC1b225968-aff7-4959-89e1-a8edabb4d6702017-05-22WarningsExact identifier
unii: F5UM2KM3W7
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
CVS Pain Relieving First Aid AntisepticLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy454b1773-eda8-5610-e054-00144ff88e882017-01-04WarningsExact identifier
unii: F5UM2KM3W7
CVS Pharmacy Sensitive Medicated CreamBENZOCAINE, BENZALKONIUM CHLORIDECVS Pharmacy454c3458-7e40-0e5e-e054-00144ff8d46c2017-01-04WarningsExact identifier
unii: F5UM2KM3W7
Sit CleanBENZALKONIUM CHLORIDESit Cleanef2b12f8-89b3-47c4-88bd-8712a84cfc452016-08-18WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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