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 75 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAN X E2BENZALKONIUM CHLORIDEAmerisan, LLCd6e2f275-4609-24e6-e053-2995a90a8dd32024-12-16WarningsExact identifier
unii: F5UM2KM3W7
KleenLine Essentials E2 Free and Clear Antibacterial HandSoapBENZALKONIUM CHLORIDEBrady Industries29681aee-d7a3-17e8-e063-6294a90a5ae92024-12-16WarningsExact identifier
unii: F5UM2KM3W7
KleenLine Essentials Antibacterial Foaming HandSoapBENZALKONIUM CHLORIDEBrady Industries2968ddad-598b-163b-e063-6294a90a57222024-12-16WarningsExact identifier
unii: F5UM2KM3W7
Soft Care Instant Hand Sanitizer AFBENZALKONIUM CHLORIDEDiversey, Inc.16846c69-b7e6-4ebe-b142-f1bf9b62c3282024-12-16WarningsExact identifier
unii: F5UM2KM3W7
OfloxacinOFLOXACIN OTICCaplin Steriles Limited2bb61a24-87a6-4e74-a319-fc5e7c483bbb2024-12-16Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
Appeal Antibacterial Hand WashBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.357a4349-76f5-47b8-ae72-b1dbe19938862024-12-16WarningsExact identifier
unii: F5UM2KM3W7
SoftenSure Antimicrobial FoamBENZALKONIUM CHLORIDEBest Sanitizers, Inc29286676-a07f-78e3-e063-6294a90a4ac52024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Primory Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.3459ed2b-9440-4139-9262-f055d3980af72024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Mentholatum Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEThe Mentholatum Company365c93bc-2299-4e69-ba3a-69414bfe78d72024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Signatry Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.ab87b641-fdcd-4a64-8c38-f2def849a4312024-12-13WarningsExact identifier
unii: F5UM2KM3W7
PURELL Foodservice HEALTHY SP 0.5pct BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, Inc.a3061ef3-e4d7-49dd-b4cf-f71bf20dbfd22024-12-13WarningsExact identifier
unii: F5UM2KM3W7
PURELL Healthcare HEALTHY SP 0.5 BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, Inc.6f1b969e-77b9-46fd-8642-ffce87a73ecb2024-12-13WarningsExact identifier
unii: F5UM2KM3W7
GOJO Antibacterial Plum Foam Handwash with Biobased contentBENZALKONIUM CHLORIDEGOJO Industries, Inc.38abc40e-2f61-4436-9814-8586bf7d1acb2024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Excelon Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.2e2883e2-dc0d-4b35-93be-514b85339c632024-12-12WarningsExact identifier
unii: F5UM2KM3W7
PURELL Hand Sanitizing Wipes Clean Refreshing ScentBENZALKONIUM CHLORIDE WIPEGOJO Industries, Inc.4a8862cd-682f-4419-8f0c-794bae243e652024-12-12WarningsExact identifier
unii: F5UM2KM3W7
PURELL Hand Sanitizing WipesBENZALKONIUM CHLORIDEGOJO Industries, Inc.70e0e729-4203-4258-97d3-2ad2eabf41e62024-12-12WarningsExact identifier
unii: F5UM2KM3W7
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 451W47IQ8X
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Dial refresh and renew Antibacterial Mountain FreshBENZALKONIUM CHLORIDEHenkel Corporationf9a347aa-808c-2095-e053-6394a90a58b12024-12-10WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial with VitaminsBENZALKONIUM CHLORIDEHenkel Corporationefd567c3-d75e-cf05-e053-2995a90af6912024-12-10WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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