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 28 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dial Antibacterial and Sensitive AloeDIAL ANTIBACTERIAL AND SENSITIVE DEODORANT BAR SOAP HYPOALLERGENIC ALOE SCENTHenkel Corporation27c4d6fe-7562-073f-e063-6394a90afe9f2025-12-16WarningsExact identifier
unii: F5UM2KM3W7
Dial Professional Original Gold AntibacterialDIAL PROFESSIONAL ORIGINAL GOLD ANTIBACTERIAL HAND SOAPHenkel Corporation287965b6-5194-9d5c-e063-6394a90a4b682025-12-16WarningsExact identifier
unii: F5UM2KM3W7
I.C. Hand SanitizerBENZALKONIUM CHLORIDER&R Lotion, Inc.5361bb71-cc84-4a76-a0cf-2259a615baa42025-12-16WarningsExact identifier
unii: F5UM2KM3W7
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
unii: F5UM2KM3W7
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
unii: F5UM2KM3W7
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
unii: F5UM2KM3W7
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
unii: F5UM2KM3W7
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e11238b-e5f2-075f-e063-6394a90aa8252025-12-15WarningsExact identifier
unii: F5UM2KM3W7
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact identifier
unii: F5UM2KM3W7
TIMOLOL MALEATETIMOLOL MALEATERising Pharma Holdings, Inc.2ed21930-1e05-46de-8acd-cb6f4798a7fa2025-12-15Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
unii: F5UM2KM3W7
BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry BerryBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics75ae3b5e-b583-4b80-b4ab-5cc40978ca302025-12-12WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial Vitamin BarDIAL ANTIBACTERIAL VITAMIN BAR SOAPHenkel Corporation292bf620-5cde-388d-e063-6394a90a307c2025-12-11WarningsExact identifier
unii: F5UM2KM3W7
Bright Amber AntibacterialBENZALKONIUM CHLORIDEColgate-Palmolive Company44f9cf18-dd2d-4637-a5e1-3db82a1904ff2025-12-11WarningsExact identifier
unii: F5UM2KM3W7
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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