FDA.reportPublic FDA data

NDC 0517-0761 - Ofloxacin

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
0517-0761
Package NDCs from labels
0517-0761-01
Manufacturer
American Regent, Inc. | PharmaForce, Inc.
Effective date
2010-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)American Regent, Inc. | PharmaForce, Inc.2010-07-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0517-0761-012019-10-21C16284748780-1956f9ecf-c04e-621f-e053-dbdaa90a74adOFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0761-01Ofloxacin10 mL in 1 BOTTLESOLUTION/ DROPS101
0517-0761-01Ofloxacin1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0761OFLOXACIN SOLUTION/ DROPS [AMERICAN REGENT, INC.]12 package rows20180616_227e11ab-4e07-4e34-b21d-ef965bae6272.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 35 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: 451W47IQ8X
WOUND WIPESBENZALKONIUM CHLORIDEHART Health4942195e-2941-4111-8ab7-2891c316bd272025-12-31WarningsExact identifier
unii: F5UM2KM3W7
MYSTIC FOAMING ANTI-BACTERIAL HANDSOAPBENZALKONIUM CHLORIDEEcolab Inc.5fe2b669-6a7a-49a5-8374-ad6298944e5c2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Advanced Antibacterial Foaming Hand SoapBENZALKONIUM CHLORIDEEcolab Inc.ea6d45ee-7713-4a90-81a8-6963c7f5c2302025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Clean ForceBENZALKONIUM CHLORIDEEcolab Inc.3f1ccba5-fc68-4e9b-8122-71b45dfa12822025-12-30WarningsExact identifier
unii: F5UM2KM3W7
PureForceBENZALKONIUM CHLORIDEEcolab Inc.4c2bcf98-a2c8-48ee-a3e0-e49cb667b27e2025-12-30WarningsExact identifier
unii: F5UM2KM3W7
EXP Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.468acf2d-97ff-4cac-91b1-067a1ea382f32025-12-30WarningsExact identifier
unii: F5UM2KM3W7
OfloxacinOFLOXACINRedpharm Drug2fbd51a5-462c-4741-e063-6394a90a0d872025-12-30Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
FIRST MARK ULTRA FOAMING ANTIBACTERIALBENZALKONIUM CHLORIDEPerformance Food Group968c0f18-d0b6-4f29-b001-00ac314a3bdd2025-12-30WarningsExact identifier
unii: F5UM2KM3W7
EcolabBENZALKONIUM CHLORIDEEcolab Inc.5b0701df-130b-49c4-8df6-101202e655ab2025-12-30WarningsExact identifier
unii: F5UM2KM3W7
tazza JIM WIPESBENZALKONIUM CHLORIDETazza Brands East, Inc.47008b6a-4882-d4a0-e063-6394a90ab85f2025-12-29WarningsExact identifier
unii: F5UM2KM3W7
MG FoamSanBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.c5311836-674a-400b-a0d3-92f959d926822025-12-29WarningsExact identifier
unii: F5UM2KM3W7
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
ANTIBACTERIAL LAVENDER BOUQUETBENZALKONIUM CHLORIDEUniversal Distribution Center LLC37dde4b1-872e-4079-9936-66f33b9320d92025-12-29WarningsExact identifier
unii: F5UM2KM3W7
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Zep FS Antimicrobial Hand CleanerBENZALKONIUM CHLORIDEZep Inc.a5ee28cb-edd6-0a58-e053-2a95a90a87892025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Fuzion Antimicrobial Hand CleanerBENZALKONIUM CHLORIDEZep Inc.a5ff51d4-2735-993b-e053-2a95a90a85952025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Antibacterial HSBENZALKONIUM CHLORIDEZep Inc.b43c3dea-b8f9-a384-e053-2995a90abe8c2025-12-26WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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