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 46 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
unii: F5UM2KM3W7
Jade Antibacterial HandBENZALKONIUM CHLORIDEWhisk Products, Inc.6386cc10-3699-47c8-aea7-01adbff826222025-01-15WarningsExact identifier
unii: F5UM2KM3W7
FOAM-BAC Antibacterial HandBENZALKONIUM CHLORIDEWhisk Products, Inc.f7ab10b8-1750-436f-a762-6d4d2ca522422025-01-15WarningsExact identifier
unii: F5UM2KM3W7
Natural Extensions Antibacterial Foaming HandBENZALKONIUM CHLORIDEBenco Dentalc51f4430-6877-4f46-a5c7-d61b30b908222025-01-15WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic TowelettesBENZALKONIUM CHLORIDECMC Group Inc.d7470f98-4278-415b-92e7-9eca2036bc092025-01-13WarningsExact identifier
unii: F5UM2KM3W7
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
unii: F5UM2KM3W7
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
unii: F5UM2KM3W7
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
unii: F5UM2KM3W7
Chemstation Q E2BENZALKONIUM CHLORIDEChemstation4a3e3617-56c3-6b64-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Chemstation HACCP Q E2BENZALKONIUM CHLORIDEChemStation4a39ce0a-5a26-6f30-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial 2X Ultra cleansingBENZALKONIUM CHLORIDESante Manufacturing Incca1899bb-126c-6bd6-e053-2995a90a14312025-01-09WarningsExact identifier
unii: F5UM2KM3W7
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: 1Q73Q2JULR
KleenLine NRG10 No-Touch Antimicrobial Foam Handwash Fragrance FreeBENZALKONIUM CHLORIDEEnvoy Solutions, LLCe49a7192-1a07-4c7e-9bf0-3402c69ad65f2025-01-09WarningsExact identifier
unii: F5UM2KM3W7
Victoria Bay Antimicrobial Foam Handwash 1200 mLBENZALKONIUM CHLORIDEDade Paper & Bag, LLCe3940912-48c1-4316-8ec3-02476df6c1c92025-01-09WarningsExact identifier
unii: F5UM2KM3W7
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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