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 57 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol MaleateTIMOLOL MALEATE OPHTHALMICMicro Labs Limited6c9f3971-8c07-4d3a-915d-76438baa2a0b2024-10-03Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
DiaSincBENZALKONIUM CHLORIDEPureTek Corporationd9ba1ca8-8883-11bb-e053-2995a90a58462024-10-02WarningsExact identifier
unii: F5UM2KM3W7
GenRx Hand SanitizingBENZALKONIUM CHLORIDEPureTek Corporationa12715c0-77f2-7716-e053-2995a90a06d32024-10-02WarningsExact identifier
unii: F5UM2KM3W7
Wet Ones Antibacterial Non Plastic Hand WipesBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLCe9abef25-773e-b67f-e053-2995a90a36402024-10-01WarningsExact identifier
unii: F5UM2KM3W7
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEMicro Labs Limitedf45cce05-fb47-4607-b68e-5a3d47e7235a2024-09-26Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
unii: F5UM2KM3W7
Dial antibacterial and sensitive hypoallergenic barBENZALKONIUM CHLORIDEHenkel Corporation2269bac8-b724-feb8-e063-6394a90a52ff2024-09-18WarningsExact identifier
unii: F5UM2KM3W7
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATESomerset Therapeutics, LLC17f04726-725f-4839-911d-47fc5e02baae2024-09-18Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
WhiskCare 377BENZALKONIUM CHLORIDEWhisk Products, Inc.124b403f-d12e-6e5c-e063-6394a90a63f82024-09-13WarningsExact identifier
unii: F5UM2KM3W7
Sani-Sure AFBENZALKONIUM CHLORIDEWhisk Products, Inc.215edd45-6266-0bfe-e063-6294a90ae9ea2024-09-05WarningsExact identifier
unii: F5UM2KM3W7
Thompson AntisepticBENZALKONIUM CHLORIDEThompson0c009ed0-23b8-e4b3-e063-6394a90a723d2024-09-04WarningsExact identifier
unii: F5UM2KM3W7
Bravo Sierra - Antibacterial Body WipesBENZALKONIUM CHLORIDE WIPESUnderscore USA20ed5566-9014-e35b-e063-6294a90a003a2024-08-30WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 377 FreeBENZALKONIUM CHLORIDEWhisk Products, Inc.0bf163a6-0239-932c-e063-6394a90a12ab2024-08-28WarningsExact identifier
unii: F5UM2KM3W7
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Inc.5ad43fd4-19f0-448f-97a8-625ada4cb1472024-08-27Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Limitedfb2e0729-b0bc-4c3f-9961-8bb38f84a0322024-08-27Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEBryant Ranch Prepackcfdc5577-fe7a-4b51-b2f5-95806e1dee2d2024-08-20Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATECaplin Steriles Limited4847f180-45e6-40f0-ae8c-6cc500cb0add2024-08-19Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
unii: F5UM2KM3W7
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unileverb9f65122-4037-de0b-e053-2995a90ae5102024-08-16WarningsExact identifier
unii: F5UM2KM3W7
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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