FDA.reportPublic FDA data

NDC 80425-0366-01 - Tobramycin and Dexamethasone

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
80425-0366
Requested NDC
80425-0366-01
Package NDCs from labels
80425-0366-1, 80425-0366-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin and Dexamethasone - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0366-1Tobramycin and Dexamethasone5 mL in 1 BOTTLESUSPENSION/ DROPS52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0366TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 1 package rows20250101_09315f0b-f15a-30d5-e063-6394a90ac8dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0366-1ML - Milliliter80425-0366dda8d509-96d2-4b7a-8923-64f4cf3c30e712023-12-05

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 31 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foaming HandBENZALKONIUM CHLORIDECintas Corporation17fb34e7-c9e6-41aa-991f-bb54c84ed79c2026-02-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
RELEEV Cold Sore TreatmentBENZALKONIUM CHLORIDEMerix Pharmaceutical Corp.fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf2026-02-02WarningsExact identifier
unii: F5UM2KM3W7
CLUB WIPES USA SANITIZING WIPESBENZALKONIUM CHLORIDEBubble Marketing LLCa0e4b04c-2227-49d2-8ccc-c7647b07cb022026-02-02WarningsExact identifier
unii: F5UM2KM3W7
SUPREP Bowel PrepSODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATEAzurity Pharmaceuticals, Inc.50f23abd-6a66-44cb-960e-d43c16a5ae5f2026-01-31Warnings, Adverse reactionsExact identifier
unii: 0YPR65R21J
SUTABSODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.c020e973-dccf-4862-999e-17db6209a48a2026-01-31Warnings, Adverse reactionsExact identifier
unii: 0YPR65R21J
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Aldi, LLCbcde5681-5bc6-41a7-890e-27ba6f4e4be62026-01-29Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutionscdd9086d-821f-4ac8-bc49-f1869dffb1502026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
My-Shield Sanitizing BodyBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd4ed5da9-cc32-447d-994e-6242c3fb5f782026-01-29WarningsExact identifier
unii: F5UM2KM3W7
germfree24 Sanitizing Body-SprayBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc9099b7d6-b3af-43ad-922f-e6586c89addc2026-01-29WarningsExact identifier
unii: F5UM2KM3W7
ProBliva Antibacterial and Acne Body WashANTIBACTERIAL AND ACNE BODY WASHCAVTECH HOLDING LLC496f7a1e-05b6-d434-e063-6394a90afe542026-01-28WarningsExact identifier
unii: F5UM2KM3W7
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation1409c437-ff17-481d-94be-87dd6d463ba92026-01-28WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4906f079-8c9f-e3b0-e063-6294a90ad0f82026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4912b681-e21a-1ddf-e063-6294a90aa9f42026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491a6d77-8a84-c76d-e063-6394a90ac61f2026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491b55ca-2c7a-0eb7-e063-6394a90a9cb72026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491c4af8-c699-7128-e063-6294a90ae0f92026-01-26WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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