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 60 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
unii: F5UM2KM3W7
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions1ffd9ed1-8ab4-4036-bbc6-dcf58e6592482024-06-03Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.7873638a-afd7-4b55-bcc5-0e893a437fb32024-05-31WarningsExact identifier
unii: F5UM2KM3W7
Timolol GFSTIMOLOL MALEATESandoz Inc72b0d0ec-832a-4c25-b845-2537ab5063542024-05-28Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide and TimololDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTIONLeading Pharma, LLCc9ae08c5-275d-44b3-9d1e-5d8fedc21b962024-05-25Warnings, Adverse reactionsExact identifier
application number: ANDA205295
unii: QZO5366EW7
unii: P8Y54F701R
Dorzolamide hydrochlorideDORZOLAMIDE HYDROCHLORIDELeading Pharma, LLC7d4cb6cd-86d0-41d9-baa9-bca0fa7b06942024-05-24Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
unii: F5UM2KM3W7
TIMOLOL MALEATETIMOLOL MALEATEAurobindo Pharma Limitede6c74f66-ee84-4bcc-b1da-b8e6ff240dd22024-05-16Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
unii: F5UM2KM3W7
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGland Pharma Limitedefab039e-a69d-4306-8305-b1d27781cfe02024-05-14Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
unii: F5UM2KM3W7
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
unii: F5UM2KM3W7
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
unii: F5UM2KM3W7
Tork Hand Sanitizer Alcohol Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCd2e6d469-ddcc-4cad-829f-245dc1ec83682024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Tork Foam AntibacterialBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC45416b88-3703-4934-9439-9f23233427442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial Foam with Moisturizers Tranquil AloeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe0bded7-a268-db59-e053-6294a90aee442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
GP enMotion Antimicrobial FoamBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsc846eb52-3db4-1a74-e053-2a95a90aa84d2024-05-02WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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