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 47 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dial Professional Antibacterial Defense Spring WaterBENZALKONIUM CHLORIDEHenkel Corporation29644a9d-3954-a6e5-e063-6394a90a82c72025-12-09WarningsExact identifier
unii: F5UM2KM3W7
Dial Professional Antibacterial Foaming Hand Wash Spring WaterDIAL PROFESSIONAL ANTIBACTERIAL FOAMING HAND SOAP SPRING WATER SCENTHenkel Corporation28dc867c-ca9b-4631-e063-6394a90a9a352025-12-09WarningsExact identifier
unii: F5UM2KM3W7
DEXAMETHASONEDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.a8d6792e-757e-4dc6-adf5-0d92110754282025-12-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDESOLA Pharmaceuticals, LLC4d0bfd28-460a-48ba-bd17-cf75e56d62f42025-12-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DANDI HPMILK THISTLE, DYSPHANIA AMBROSIOIDES, BOS TAURUS BILE, GOLDEN SEAL, POTASSIUM TARTRATE HEMIHYDRATE, TARAXACUM OFFICINALE, IODINE, ARSENIC TRIOXIDE, OSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CHLORIDE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUSNatural Creations, Inc.44c7d388-6c40-47e2-9760-4e5075fc0e7b2025-12-08WarningsExact identifier
unii: 0YPR65R21J
BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry BerryBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics56b559c6-db10-47dd-9316-cc2d04cbef982025-12-08WarningsExact identifier
unii: F5UM2KM3W7
Babyganics Alcohol-Free Hand Sanitizer Wipes MandarinBENZALKONIUM CHLORIDEKAS Direct, LLCd93300b3-2c9b-4623-ae4b-907e857ce5ae2025-12-08WarningsExact identifier
unii: F5UM2KM3W7
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
unii: F5UM2KM3W7
BabyGanics Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics16d83c80-a1a6-490b-b065-35a10a36592f2025-12-05WarningsExact identifier
unii: F5UM2KM3W7
BabyGanics Alcohol-Free Foaming Hand Sanitizer MandarinBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics19304d65-aee9-42dd-aea8-61a7b8c9beb62025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial WipesBENZALKONIUM CHLORIDEERC Acquisition, Incdc6c39af-447c-481a-98b5-33b8f09b83bc2025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Sanitex Antibacterial Hand Wipes Fresh ScentBENZALKONIUM CHLORIDEPrecare Corp48907146-ca66-46e1-928b-a8f968a6bff82025-12-05WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESQuest USA Corpd9ab219d-07e3-2019-e053-2a95a90a16682025-12-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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