FDA.reportPublic FDA data

NDC 55545-1007-1 - 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
55545-1007-1
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 47 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
unii: F5UM2KM3W7
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
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc00179db3-5a76-4724-a848-28e71eb580a62025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc3e65e67d-c7d0-2fcb-e054-00144ff8d46c2025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Aqua Clear 2X UltraBENZALKONIUM CHLORIDESante Manufacturing Incd5d15729-1dc1-2b44-e053-2a95a90a26c52025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Sipa hand sanitizer S.pray with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbc3c5d-c231-9024-e053-6294a90a9c592025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Ormadus Foodservice Antibacterial FoamBENZALKONIUM CHLORIDESC Johnson Professional USA Inc71cd4be3-1cdf-4e49-be7b-405fe12288d22025-01-07WarningsExact identifier
unii: F5UM2KM3W7
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial BathingBENZALKONIUM CHLORIDECardinal Health, Inc.586463f3-d117-47ae-bbab-f7caff1f5fa82025-01-06WarningsExact identifier
unii: F5UM2KM3W7
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
unii: F5UM2KM3W7
Anti-Bacterial WipesBENZALKONIUM CHLORIDETongling Jieya Biological Technology Co., Ltd.d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d2025-01-04WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufcaturing Inc205eb8f9-55fd-266e-e063-6294a90a4b3e2025-01-03WarningsExact identifier
unii: F5UM2KM3W7
Sipa Foam hand sanitizer with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcb9fe65-837c-011b-e053-6294a90a46052025-01-02WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufacturing Inc3e64d344-8883-0235-e054-00144ff8d46c2025-01-02WarningsExact identifier
unii: F5UM2KM3W7
Dial refresh and renew Antibacterial whiteBENZALKONIUM CHLORIDEHenkel Corporationf7f5ed83-1b9b-230a-e053-6394a90ad2ae2025-01-01WarningsExact identifier
unii: F5UM2KM3W7
Total Solutions Alcohol-Free Hand Sanitizing WipesBENZALKONIUMAthea Laboratories, Inc.2ce0d8ad-2734-33df-e063-6394a90ab7282025-01-01WarningsExact identifier
unii: F5UM2KM3W7
Total Solutions Alcohol-Free Hand Sanitizing FoamBENZALKONIUMAthea Laboratories, Inc.2f37a2a1-5252-4052-e063-6294a90aef7f2025-01-01WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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