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 39 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wipex Sanitizing WipesBENZALKONIUM CHLORIDEUnico476d7085-82d8-5e84-e063-6394a90a64482026-01-02WarningsExact identifier
unii: F5UM2KM3W7
Max OUTBENZALKONIUM CHLORIDEUnico475903d2-a0b0-5d29-e063-6394a90a528f2026-01-01WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic wipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.fc4fc127-3130-4891-b390-6dc823cb30d42026-01-01WarningsExact identifier
unii: F5UM2KM3W7
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Ecolab Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.7bc85519-64cb-48a3-bbd6-73e03b1d06112025-12-31WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD470fca9f-a819-2290-e063-6294a90abad82025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze ScentBENZALKONIUM CHLORIDEQuest USA Corpf6130f88-a274-4068-9d8e-5f898b3b074f2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Anti-bacterial Hand Wipes Honey Wildflower ScentBENZALKONIUM CHLORIDEQuest USA Corpd5db76a3-871e-4110-afc3-80f84a77eb2b2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 WipesBENZALKONIUM CHLORIDEQUEST USA CORP.ae2fdb32-05c6-6d16-e053-2995a90a552d2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
unii: F5UM2KM3W7
Immune BoostCHERRY PLUM, FERR PHOS, HORNBEAM, KALI SULPH, NAT MUR, OAK, OLIVE, THYMUS (CALF), ZINC MURSiddha Flower Essences LLCe8d44b65-47ef-ebc7-e053-2995a90a85832025-12-31WarningsExact identifier
unii: 451W47IQ8X
Biopure Pocket Size Singles Fresh Breeze ScentBENZALKONIUM CHLORIDEQuest USA Corpd618e4fc-a37d-417f-8b4d-90bb31280cff2025-12-31WarningsExact identifier
unii: F5UM2KM3W7
emotional detoxCALC PHOS, CALC SULPH, CASTANEA SATIVA, FLOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPAEA, FLOS, ORNITHOGALUM UMBELLATUM, FLOSSiddha Flower Essences LLC385fb878-dd8f-40ae-82a3-874d6a6cceb22025-12-31WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
happy heartBROMUS RAMOSUS, FLOS, CALC FLUOR, CENTAURIUM UMBELLATUM, FLOS, FER PHOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, MAG PHOS, NAT MURSiddha Flower Essences LLCadb25966-b49a-48a9-a4ce-3ad7a2d7a7122025-12-31WarningsExact identifier
unii: 451W47IQ8X
digestAESCULUS HIPPOCASTANUM, BUD, CAL PHOS, CARPINUS BETULUS, FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPH, ULMUS PROCERA, FLOSSiddha Flower Essences LLC99886d33-d8e0-4f58-89fa-e5071b30a98e2025-12-31WarningsExact identifier
unii: 451W47IQ8X
blood sugarCALC PHOS, CARPINUS BETULUS, FLOS, FERRUM PHOS, KALI PHOS, NAT MUR, NAT SULPH, OLEA EUROPAEA, FLOS, SILICEA, SINAPIS ARVENSIS, FLOSSiddha Flower Essences, LLC90ecd62b-c4bc-4bc4-a409-219929a49edb2025-12-31WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
mood and patienceCALC PHOS, CALC SULPH, CARPINUS BETULUS FLOS, FER PHOS, ILEX AQUIFOLIUM FLOS, IMPATIENS GLANDULIFERA FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPHSiddha Flower Essences LLC03f55295-94f9-44f6-9386-ea2741a0f8be2025-12-31WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
sleepAESCULUS HIPPOCASTANUM, FLOS, FERRUM PHOS, KALI CARB, KALI PHOS, MAG PHOS, NAT MUR, POPULUS TERMULA, FLOS, PRUNUS CERASIFERA, FLOSSiddha Flower Essences LLCdc353895-3a58-475c-8afd-ab08b27b96c32025-12-31WarningsExact identifier
unii: 451W47IQ8X
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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