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 76 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Antibacterial Clean and SmoothBENZALKONIUM CHLORIDEEcolab Inc.881a94a1-68b8-4152-bdaa-e736812e889a2024-12-10WarningsExact identifier
unii: F5UM2KM3W7
SoftSoap Antibacterial Kitchen Fresh HandsBENZALKONIUM CHLORIDEColgate-Palmolive Company65155ce6-5551-491b-a3df-e8ac2cc90ef12024-12-10WarningsExact identifier
unii: F5UM2KM3W7
DermaCen Non-Alcohol Foaming Hand SanitizerBENZALKONIUM CHLORIDECentral Solutions Incc7aa7ea9-7937-45bb-b32e-dd644dbf764e2024-12-09WarningsExact identifier
unii: F5UM2KM3W7
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
unii: F5UM2KM3W7
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global47276148-08e5-400e-94ac-d2d9db423b512024-12-06WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH CUCUMBER and TEA TREEBENZALKONIUM CHLORIDEUniversal Distribution Center LLC585ee68f-14fc-4b1f-b078-d31251bbc3f32024-12-06WarningsExact identifier
unii: F5UM2KM3W7
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH PEACH DREAMBENZALKONIUM CHLORIDEUniversal Distribution Center LLC7479686e-10f1-49e0-e053-2a91aa0ae8822024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH LAVENDER BOUQUETBENZALKONIUM CHLORIDEUniversal Distribution Center LLC747a47d8-e5bc-1233-e053-2a91aa0a40932024-12-05WarningsExact identifier
unii: F5UM2KM3W7
Alpet Q E2BENZALKONIUM CHLORIDEBest Sanitizers, Incb5701ea7-60a8-4dcd-8a32-42029960c5592024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ALPET QE2 SANITIZING FOAMBENZALKONIUM CHLORIDEBest Sanitizers, Inc.0aa71f9d-f660-4a32-b54a-1968aea9d0ee2024-12-05WarningsExact identifier
unii: F5UM2KM3W7
HACCP Q E2 SanitizingBENZALKONIUM CHLORIDEBest Sanitizers, Inc.b5f48d59-8062-4b72-b87d-5825a519f5f92024-12-05WarningsExact identifier
unii: F5UM2KM3W7
HACCP QE2BENZALKONIUM CHLORIDEBest Sanitizers, Inc0b861f72-f93e-40d6-9967-43e5f6b7c1282024-12-05WarningsExact identifier
unii: F5UM2KM3W7
OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.615921dd-46e5-403c-9ed3-f30beb0c0bb92024-12-05WarningsExact identifier
unii: F5UM2KM3W7
BLACK OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d3366750-18b8-1194-e053-2995a90a43592024-12-05WarningsExact identifier
unii: F5UM2KM3W7
BLACK OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d335bf6d-dc75-bd80-e053-2a95a90abb562024-12-05WarningsExact identifier
unii: F5UM2KM3W7
OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d4c65a93-832a-6a8b-e053-2a95a90a77b82024-12-05WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH BERRY MEDLEYBENZALKONIUM CHLORIDEUniversal Distribution Center LLC747b366d-4854-52e8-e053-2a91aa0a67592024-12-05WarningsExact identifier
unii: F5UM2KM3W7
antiseptic towelette 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.e9f2a1f1-ceb6-2f20-e053-2a95a90a18db2024-12-04WarningsExact identifier
unii: F5UM2KM3W7
PURELL HEALTHY SP BAK E2 Antimicrobial Foam SpBENZALKONIUM CHLORIDEGOJO Industries, Inc.4ea02d8a-cb03-4e9e-b63d-72b83fa816f82024-12-03WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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