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 36 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zep FS Antimicrobial Foaming Hand CleanerBENZALKONIUM CHLORIDEZep Inc.b43e7d79-8de3-b151-e053-2a95a90afc7b2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Fuzion AB FoamBENZALKONIUM CHLORIDEZep Inc.b43ea64e-f7db-2250-e053-2995a90a43b32025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Mild AntibacterialBENZALKONIUM CHLORIDEZep Inc.b43c3030-2ef1-23a0-e053-2995a90a36a62025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Acclaim ABBENZALKONIUM CHLORIDEZep Inc.b43c0b5b-b476-fdc3-e053-2a95a90a70b32025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Blue Sky ABBENZALKONIUM CHLORIDEZep Inc.b4643941-bb50-a3bb-e053-2995a90a5c162025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Handstand AntimicrobialBENZALKONIUM CHLORIDEZep Inc.b4645d99-d956-3f67-e053-2995a90a82bf2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Mango ABBENZALKONIUM CHLORIDEZep Inc.b43ffcbe-d47a-5883-e053-2a95a90acf9a2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Acclaim ABBENZALKONIUM CHLORIDEZep Inc.b43bc291-bf12-fea6-e053-2a95a90aa74a2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Professional Mild ABBENZALKONIUM CHLORIDEZep Inc.b43b2607-a546-5109-e053-2a95a90a889e2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Fuzion FS Antimicrobial Foaming Hand CleanerBENZALKONIUM CHLORIDEZep Inc.b43e9dff-4260-26a5-e053-2995a90a85702025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Tranq Mdw AB FoamBENZALKONIUM CHLORIDEZep Inc.5c3c1ab7-96a7-6ca5-e053-2991aa0af2b92025-12-26WarningsExact identifier
unii: F5UM2KM3W7
ZEP PEAR AB HSBENZALKONIUM CHLORIDEZep Inc.5bc1cc32-5d18-00a8-e053-2991aa0a0c812025-12-26WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL BERRY MEDLEYBENZALKONIUM CHLORIDEUniversal Distribution Center LLC0619a051-3f7d-4037-962c-e2e855a123422025-12-26WarningsExact identifier
unii: F5UM2KM3W7
YELLOW ESSENTIALS SANITIZING WIPES87039-001Gritt Commercial Inc.3d403feb-0d15-d6cd-e063-6394a90a15e62025-12-25WarningsExact identifier
unii: F5UM2KM3W7
Triple Allergy DefenseALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, LEMNA MINOR, LUFFA OPERCULATA, NATRUM MURIATICUM, POLYPORUS PINICOLA, SABADILLANenningers Naturals, LLCe1459ef4-6980-4b2b-94c1-6c896a9cb6bd2025-12-25WarningsExact identifier
unii: 451W47IQ8X
Dr. Nenninger Cold and Sinus SolutionALLIUM CEPA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLANenningers Naturals, LLC1e26b25c-5d93-4f69-aa9e-a187abd6d0352025-12-25WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
unii: 451W47IQ8X
GoodEarth Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution LLC1c4ec3cb-b7a4-73c9-e063-6394a90afeda2025-12-24WarningsExact identifier
unii: F5UM2KM3W7
tazza HAND SANITIZERBENZALKONIUM CHLORIDETazza Brands East Inc.327b9971-808d-ff93-e063-6394a90adce42025-12-24WarningsExact identifier
unii: F5UM2KM3W7
CLEANZ ECO BAMBOO WIPESWIPESMcF Holdings LLCeb85292a-41a3-67b0-e053-2a95a90ab4612025-12-24WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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