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 60 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
MOONIES Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEHangzhou Chunchi Touring Commodity Co., Ltd.3eee1a5c-e926-5251-e063-6294a90a5d2e2025-09-17WarningsExact identifier
unii: F5UM2KM3W7
MyTerra Hand Sanitizer Foam NABENZALKONIUM CHLORIDEPortionPac Chemical Corporation207ed8a6-b8db-43c9-9335-b313b16af9d52025-09-17WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEGertex Hosierya182eafa-0ce0-4b99-bcb0-23f9a8de9e1f2025-09-17WarningsExact identifier
unii: F5UM2KM3W7
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC190d7d61-5ea9-6670-e063-6294a90a45352025-09-17WarningsExact identifier
unii: F5UM2KM3W7
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC231ba8dd-e827-bc79-e063-6394a90a75382025-09-17WarningsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONEApotex Corp.bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf22025-09-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
I.C. Waterless Hand Cleaner with Micro ScrubbersBENZALKONIUM CHLORIDER & R Lotion, Inca0bcc8a1-8bc6-4a42-b12d-ea1f3d9977a62025-09-15WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideANTIBACTERIAL WET WIPESDiamond Wipes International9296f7ad-eab9-4336-b0fa-8297a070fd182025-09-11WarningsExact identifier
unii: F5UM2KM3W7
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
I.C. Antibacterial Hand CleanerBENZALKONIUM CHLORIDER & R Lotion, Incafd59808-4ab7-4752-b358-6b21b5d4ad302025-09-10WarningsExact identifier
unii: F5UM2KM3W7
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
I.C. Sanitizer and Re-Moisturizer with Benzalkonium ChlorideBENZALKONIUM CHLORIDER & R Lotion, Inccc5f24c8-fb85-49bd-8f55-4ec72fc0ffff2025-09-10WarningsExact identifier
unii: F5UM2KM3W7
Medi-First Plus Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation57ea7f8a-26e2-367e-e053-2a91aa0a93e12025-09-09WarningsExact identifier
unii: F5UM2KM3W7
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationf2b7e1c4-6369-9efa-e053-2a95a90a82122025-09-09WarningsExact identifier
unii: F5UM2KM3W7
ECOLAB AntisepticBENZALKONIUM CHLORIDEEcolab Food Safety Specialties, Inc.933860e7-5a1f-453a-e053-2995a90a49022025-09-09WarningsExact identifier
unii: F5UM2KM3W7
ECOLAB Burn CreamBENZAALKONIUM CHLORIDE, LIDOCAINE HCLECOLAB Food Safety Specialties, Inc.4b2a7da9-c0e9-61c5-e054-00144ff8d46c2025-09-09WarningsExact identifier
unii: F5UM2KM3W7
ECOLAB AntisepticBENZALKONIUM CHLORIDE 0.13%ECOLAB Food Safety and Specialties, Inc.4c982e7b-2489-151f-e054-00144ff88e882025-09-09WarningsExact identifier
unii: F5UM2KM3W7
Thompson AntisepticBENZALKONIUM CHLORIDEThompsonf537c81d-1fdc-3e0f-e053-2a95a90a6c2b2025-09-09WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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