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 14 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzalkonium ChlorideLIQUID HAND SOAPAMAZON.COM SERVICES LLC1bf99b68-c8a7-d88c-e063-6294a90ad2d22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS Pharmacy Inc.e582bdcf-0d8b-39f1-e053-2995a90a01f22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f58da5-9b8b-a0f4-e063-6294a90a77d72026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Giant EagleBENZALKONIUM CHLORIDEGIANT EAGLEd2cbfc4e-d118-5202-e053-2995a90aac6c2026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care423f5f82-8521-65aa-e063-6294a90a11802026-05-20WarningsExact identifier
unii: F5UM2KM3W7
LIDLBENZALKONIUM CHLORIDELIDL US LLCca13681e-4cdd-30c7-e053-2a95a90ad05a2026-05-20WarningsExact identifier
unii: F5UM2KM3W7
WINCO CITRUS LHSBENZALKONIUM CHLORIDEWINCO FOODS, LLC261d768c-8ec7-4b16-e063-6294a90a23a02026-05-20WarningsExact identifier
unii: F5UM2KM3W7
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Caring Mill BZK TowelettesBENZALKONIUM CHLORIDEFSA Store Inc.51f20e04-3efb-9dbf-e063-6394a90a4aca2026-05-18WarningsExact identifier
unii: F5UM2KM3W7
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
unii: F5UM2KM3W7
Lightning X BZK WIPEBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.5182df99-d825-376e-e063-6394a90a54352026-05-11WarningsExact identifier
unii: F5UM2KM3W7
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
tazza ECOFIT WIPESBENZALKONIUM CHLORIDETazza Brands East Inc50a83324-cc13-3668-e063-6394a90a44ed2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
unii: F5UM2KM3W7
crisp pearBENZALKONIUM CHLORIDELIDL US LLCca58d78e-a85a-da96-e053-2995a90a60a92026-05-08WarningsExact identifier
unii: F5UM2KM3W7
HIMarkBENZALKONIUM CHLORIDEApollo Health and Beauty Caref96022c6-268b-9085-e053-6294a90a0e3f2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Better Living BrandsBENZALKONIUM CHLORIDEBetter Living Brands LLCee53ceaf-8709-459b-e053-2995a90a05e02026-05-08WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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