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 67 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
X3 Clean Foaming Hand SanitizerBENZALKONIUM CHLORIDEHK Kolmar Canada, Inc3c636145-03fe-47c7-81fc-279fef69b1c32023-10-27WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lilac Garden Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70ed1c-83db-5eaa-e053-2a95a90a92cc2023-10-27WarningsExact identifier
unii: F5UM2KM3W7
Pine and Honey Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC95b0c8b2-901b-40f8-ae75-732c3821ee472023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Vanilla Coconut Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC1932ccc6-6b8c-4dc4-bf74-1a155b596f3b2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Mountain Air Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INCc80fc58e-e2a5-4c8e-a211-abe81fc1231d2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Simply Lavender Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC8a75bcab-5a4b-4e3b-a838-2f2ce0224b8d2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Timolol MaleateTIMOLOL MALEATEIngenus Pharmaceuticals, LLC4c4318b3-9865-4172-a7bd-9e68913eca1e2023-10-25Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
g and h Protect HandBENZALKONIUM CHLORIDEAccess Business Group LLC1103a4af-10d6-478f-85cd-c364569569e52023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
unii: F5UM2KM3W7
WIPE OUT Antibacterial Wipes, Lemon ScentBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdafd72ac9-d6e8-75ec-e053-2a95a90a141d2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
WIPE OUT Antibacterial Wipes, Fresh ScentBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdafd76301-e165-7098-e053-2995a90a29262023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic Towelette SterileBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdf787ff2f-0cdf-46ee-b401-603e34a767702023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic Towelette Non-SterileBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd481dd61c-7691-44dc-83b4-c1ee6898c3be2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Cleansing ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd13c23da8-51d7-480c-b8ae-5bf91043d0a32023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic BZK ToweletteBENZALKONIUM CHLORIDECardinal Health 200, Inc.8dd79ffe-f742-438c-9814-612f900ad6a92023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizing WipesBENZALKONIUM CHLORIDEEz Products Of South Florida, LLC89dab85e-4888-442a-b8a1-4f23d356f5952023-10-23WarningsExact identifier
unii: F5UM2KM3W7
New Wave Cleaning Solutions Foaming Hand SanitizerBENZALKONIUM CHLORIDENEW WAVE CLEANING SOLUTIONS,LLCb79b2f50-4d87-5b75-e053-2995a90a40d42023-10-23WarningsExact identifier
unii: F5UM2KM3W7
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
unii: F5UM2KM3W7
Decon7 Antiseptic Foaming Hand SanitizerBENZALKONIUM CHLORIDEDecon7 Systems, LLCd167abde-6cfe-e61a-e053-2995a90accf92023-10-16WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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