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 25 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Wakefern Food Corp.d4e823bc-527b-4815-a7e0-47ee8d004e632026-02-13Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Your Military Exchanges8dd3bb4d-9cb5-4994-9c77-fa5b8e69ec2b2026-02-12Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Cucumber Mint BlissBENZALKONIUM CHLORIDER & R Lotion, Inc458dec24-b5bb-240a-e063-6294a90a81f32026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Vanilla Sugar BlissBENZALKONIUM CHLORIDER & R Lotion, Inc4a6b89dc-1c0a-61e2-e063-6294a90aeca82026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Island TranquilityBENZALKONIUM CHLORIDER & R Lotion, Inc4a7c2d9a-4bf1-d4a8-e063-6394a90ae1722026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand SanitizerBENZALKONIUM CHLORIDER & R Lotion, Inc3ba7408c-7165-448c-b31c-9890807c0cb92026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Eucalyptus TranquilityBENZALKONIUM CHLORIDER & R Lotion, Inc4a8243c4-969b-a123-e063-6394a90a342a2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
CleanseBENZALKONIUM CHLORIDE 0.13%Medline Industries, LP3c56b4c2-42f5-66d7-e054-00144ff8d46c2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
CleanseBENZALKONIUM CHLORIDEMedline Industries, LP428644dd-b2e5-1675-e054-00144ff88e882026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Incc4328104-5a17-4673-925b-3d3206994e6e2026-02-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Whispering RoseBENZALKONIUM CHLORIDER & R Lotion, Inc4a93b67c-7edc-28ad-e063-6394a90a1ac22026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Wet wipesBENZALKONIUM CHLORIDEZhejiang Easyclean Daily Chemical Co., Ltd.a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Walgreens ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTWALGREEN COMPANY48fef521-1b1d-d0d5-e063-6394a90ac7b12026-02-10WarningsExact identifier
unii: 451W47IQ8X
Walgreens SALINE MISTNASAL MISTWALGREEN COMPANY44815675-cc1d-a582-e063-6394a90ae8f62026-02-10WarningsExact identifier
unii: 451W47IQ8X
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.49e31509-d489-44be-e063-6394a90a97ef2026-02-10WarningsExact identifier
unii: F5UM2KM3W7
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VMY IMPORTS USA LLC4a849c4f-9b96-6b20-e063-6394a90a34862026-02-10WarningsExact identifier
unii: F5UM2KM3W7
Everlit Care Products Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3331e2f1-c3d0-41fc-a792-be5dcdf4e24a2026-02-09WarningsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDESalado Sales Inc.3803d8d6-ed43-4dcf-ba04-92914bfa5e9a2026-02-06Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Foaming Hand WashBENZALKONIUM CHLORIDESalado Sales Inc.b56aefb5-7134-44dd-b341-b9a3515db35e2026-02-06Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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