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 92 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gluten DetoxBARLEY (GRAIN), CARBO VEGETABILIS, CINCHONA OFFICINALIS, GLUTEN, GLYPHOSATE, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PANCREAS SUIS, PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN)Liddell Laboratories, Inc.706f2e33-8674-4911-ba0a-4efc935e77392024-11-04WarningsExact identifier
unii: 451W47IQ8X
Derma PainCALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)Liddell Laboratories, Inc.e02a5e99-aa27-4276-a785-7b5328d89fdc2024-11-04WarningsExact identifier
unii: 451W47IQ8X
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONENorthStar RxLLC130deaf4-ced5-abcb-2a01-205c640ddf962024-11-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONESandoz Inc7f2e3c46-9f39-45e7-99a9-64cc4f6f649d2024-10-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Sanar Naturals MercurochromeBENZALKONIUM CHLOLRIDESanvall Enterprises, Inc16c6c2f0-0f08-e640-e063-6394a90aa01d2024-10-31WarningsExact identifier
unii: F5UM2KM3W7
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.8c8d63b6-763a-44f8-87ef-e83a89ec37762024-10-31WarningsExact identifier
unii: 451W47IQ8X
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: 451W47IQ8X
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: F5UM2KM3W7
Weed Grass AntigensALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,Energique, Inc.0ec09d62-07ca-4bbe-9019-1025f57132112024-10-31WarningsExact identifier
unii: 451W47IQ8X
Thyroid TonicACACIA ARABICA, OLEUM OLEA EUROPAEA, SESAME OIL, FUCUS VESICULOSUS 3X, IODIUM, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAGE OIL, CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), HYDROFLUORICUM ACIDUMEnergique, Inc.aeca8e0e-12e6-44d0-a709-401d137f7cf32024-10-31WarningsExact identifier
unii: 451W47IQ8X
Softsoap Antibacterial with Moisturizers Fresh Citrus LHSBENZALKONIUM CHLORIDECOLGATE PALMOLIVE COMPANYd824aedc-dba7-4259-bbec-9e3c28c6d8fb2024-10-30WarningsExact identifier
unii: F5UM2KM3W7
Sycosis MiasmNITRICUM ACIDUM, LYCOPODIUM CLAVATUM, ARGENTUM NITRICUM, CAUSTICUM, NATRUM SULPHURICUM, THUJA OCCIDENTALISEnergique, Inc.36abaf19-c34c-41a7-9ff4-6989822e898e2024-10-30WarningsExact identifier
unii: 0YPR65R21J
SpleenparSPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUSEnergique, Inc.f89581c5-faab-42b2-b984-e369f6ff8b492024-10-30WarningsExact identifier
unii: 451W47IQ8X
Softsoap Antibacterial Sparkling PearBENZALKONIUM CHLORIDECOLGATE PALMOLIVE COMPANY7fe1c0a1-11d5-443c-924a-652d62db7a062024-10-30WarningsExact identifier
unii: F5UM2KM3W7
RITE AID Maximum strength pain relievingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDERITE AIDc87671cb-d736-4ec6-ab10-94dff54925b22024-10-30WarningsExact identifier
unii: F5UM2KM3W7
Muscle/Tendon Pain and Stress ReliefCALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)Energique, Inc.4a8f73ab-77af-4556-8bf2-96b5f5d3fb8f2024-10-29WarningsExact identifier
unii: 451W47IQ8X
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
unii: F5UM2KM3W7
Nat MurNATRUM MURIATICUMEnergique, Inc.39c4cb25-e70f-4d5a-b7b6-1b62527aa4f32024-10-29WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC68cc9c41-ed24-4f76-8efb-2936ae3ddd8d2024-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, FAGOPYRUM ESCULENTUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.d008a091-b7c6-41f1-a1cf-f8224ebe55e52024-10-29WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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