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 86 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ofloxacinOFLOXACIN OTICNuCare Pharmaceuticals,Inc.1e917318-cdc7-cd2c-e063-6294a90a0cc22024-08-02Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
Clean ForceBENZALKONIUM CHLORIDEEcolab Inc.dc7bad8c-2e29-4d5d-b87e-8d9eae7c2c1c2024-08-02WarningsExact identifier
unii: F5UM2KM3W7
SwisherBENZALKONIUM CHLORIDEEcolab Inc.9f89f162-9816-4d33-aa25-0a70477250762024-08-02WarningsExact identifier
unii: F5UM2KM3W7
Members MarkBENZALKONIUM CHLORIDEEcolab Inc.40342279-c73d-4644-8569-2b44982149e22024-08-02WarningsExact identifier
unii: F5UM2KM3W7
Equi-StatBENZALKONIUM CHLORIDEEcolab Inc.68e3174e-cb96-4739-a723-c36b2389f4f62024-08-02WarningsExact identifier
unii: F5UM2KM3W7
AVON footworks Maximum Strength Cracked HeelBENZALKONIUM CHLORIDE, LIDOCAINEThe Avon Company1f45752e-4a55-431e-e063-6294a90aa57a2024-08-01WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 377BENZALKONIUM CHLORIDEWhisk Products, Inc.2204c224-e12a-81c6-e063-6294a90a9fa42024-08-01WarningsExact identifier
unii: F5UM2KM3W7
FaciliproBENZALKONIUM CHLORIDEEcolab Inc.9948e401-6e5f-4d14-ad0b-f62735822c2a2024-08-01WarningsExact identifier
unii: F5UM2KM3W7
PureForceBENZALKONIUM CHLORIDEEcolab Inc.e624ea46-e502-4d2d-aaa1-59954f69be052024-08-01WarningsExact identifier
unii: F5UM2KM3W7
OfloxacinOFLOXACINProficient Rx LP5a9de529-6f85-467a-97b0-8ce124c311732024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 451W47IQ8X
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
EcolabBENZALKONIUM CHLORIDEEcolab Inc.70516b96-5394-4f67-92c4-c50601c259462024-07-30WarningsExact identifier
unii: F5UM2KM3W7
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.6860a80e-9a5f-40e4-bec3-e7386e541f5b2024-07-30WarningsExact identifier
unii: F5UM2KM3W7
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ofloxacin OticOFLOXACINA-S Medication Solutions9d4b1225-e20d-4ace-850a-506fd031cac72024-07-18Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
OfloxacinOFLOXACIN OTICAmneal Pharmaceuticals NY LLCba37e2a0-1bf7-41ca-bddd-35fcb77f87de2024-07-18Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
OfloxacinOFLOXACINNuCare Pharmaceuticals,Inc.af861f20-5ec8-2883-e053-2a95a90a23122024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H

Reported adverse events (FAERS/openFDA)#

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