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 27 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Inc485bf58b-bd97-d068-e063-6394a90ab3e72026-02-24Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Inc485b4296-bb2a-ceac-e063-6394a90a5bba2026-02-24Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
American Red Cross Antibacterial BarBENZALKONIUM CHLORIDEMy Imports Usa, LLCeab6bee4-e780-4f0d-aa9c-a0111f033b322026-02-23WarningsExact identifier
unii: F5UM2KM3W7
Mold PlusAGARICUS MUSCARIUS, ALLIUM CEPA, AMMONIUM CARBONICUM, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.372ad9cc-70eb-4f3f-b611-69e2d157c0582026-02-23WarningsExact identifier
unii: 0YPR65R21J
unii: O40UQP6WCF
AntibacterialBENZALKONIUM CHLORIDEMeijer, Inc.d450c423-00fa-4bb7-a0be-c14412a45e282026-02-20Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Meijer, Inc.64c7d808-aaa0-4b8b-8fef-6285059939782026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEMeijer, Inc.8fbbc798-ac00-4755-a2c2-5cd5b5c01ae42026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEMeijer, Inc.df4dbf38-669a-441a-bd6e-f5cc490d17d22026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Meijer, Inc.fbfb9940-0c17-4fdf-81f5-406d614da8722026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antiseptic Foaming Hand SanitizerBENZALKONIUM CHLORIDETarget Corporation93d6e4df-9428-4557-b251-c7aa9bda34122026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDES. P. Richards Company9223a236-9e9e-42eb-a945-dfe629e4ae3f2026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEWalmart Inc.25d227f8-2238-4f6f-aa40-b314d0179d882026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Light Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%United Natural Foods, Inc. dba UNFI36738761-293e-4864-bc08-87a5075e1ccf2026-02-17WarningsExact identifier
unii: F5UM2KM3W7
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: 0YPR65R21J
Hand WashBENZALKONIUM CHLORIDEUnited Natural Foods, Inc. dba UNFI2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd902026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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