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 43 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bolor sanitizing hand wipesBOLOR SANITIZING HAND WIPESGuangzhou Baihua Co., Ltd33dbe9e3-4335-ada1-e063-6294a90ad2f52025-05-04WarningsExact identifier
unii: F5UM2KM3W7
WIPESPLUS HAND SANITIZING ALCOHOL FREE WIPESBENZALKONIUM CHLORIDECFS Brands3400d7c2-b72b-c602-e063-6294a90a12302025-04-30WarningsExact identifier
unii: F5UM2KM3W7
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%Alembic Pharmaceuticals Inc.b909ecf0-c90a-4719-a144-9e74f457cb872025-04-25Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%Alembic Pharmaceuticals Limited9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e2025-04-25Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: 1Q73Q2JULR
FaciliproBENZALKONIUM CHLORIDEEcolab Inc.59580c40-ca37-4ac9-a2c3-ea86197cf68c2025-04-21WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
unii: F5UM2KM3W7
Aire-Master Antibacterial FoamBENZALKONIUM CHLORIDEWhisk Products, Inc.d3efefdd-46d1-48dc-899c-e85b9eee08822025-04-15WarningsExact identifier
unii: F5UM2KM3W7
Be Smart Get Prepared Antiseptic WipeBENZALKONIUM CHLORIDETotal Resources International, Incf2151af3-d76a-490f-90ff-728c350fe1682025-04-11WarningsExact identifier
unii: F5UM2KM3W7
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDEKenvue Brands LLCd3190050-d646-5957-e053-2995a90ad5212025-04-08WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRST First Aid AntisepticBENZALKONIUM CHLORIDEUltra Distributors Incb6efaca5-49d0-b000-e053-2995a90ab9aa2025-04-07WarningsExact identifier
unii: F5UM2KM3W7
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
unii: F5UM2KM3W7
EcolabBENZALKONIUM CHLORIDEEcolab Inc.f646187a-6f78-436c-a397-7541a2c691b82025-04-04WarningsExact identifier
unii: F5UM2KM3W7
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Nurture ANTISEPTIC WIPESBENZALKONIUM CHLORIDEDevon Products, LLCff2c761f-1a82-467b-9a5f-a2cdbd2be9352025-04-02WarningsExact identifier
unii: F5UM2KM3W7
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 387BENZALKONIUM CHLORIDEWhisk Products, Inc.35bb7d59-111e-fa47-e063-6394a90aaf1e2025-03-31WarningsExact identifier
unii: F5UM2KM3W7
MeijerBENZALKONIUM CHLORIDEMeijer1e69a1b6-1b2b-8db7-e063-6294a90a78e92025-03-28WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.da241df2-6153-05e4-e053-2a95a90a09842025-03-26WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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