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 42 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZEP PEAR AB HSBENZALKONIUM CHLORIDEZep Inc.5bc1cc32-5d18-00a8-e053-2991aa0a0c812025-12-26WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL BERRY MEDLEYBENZALKONIUM CHLORIDEUniversal Distribution Center LLC0619a051-3f7d-4037-962c-e2e855a123422025-12-26WarningsExact identifier
unii: F5UM2KM3W7
YELLOW ESSENTIALS SANITIZING WIPES87039-001Gritt Commercial Inc.3d403feb-0d15-d6cd-e063-6394a90a15e62025-12-25WarningsExact identifier
unii: F5UM2KM3W7
Triple Allergy DefenseALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, LEMNA MINOR, LUFFA OPERCULATA, NATRUM MURIATICUM, POLYPORUS PINICOLA, SABADILLANenningers Naturals, LLCe1459ef4-6980-4b2b-94c1-6c896a9cb6bd2025-12-25WarningsExact identifier
unii: 451W47IQ8X
Dr. Nenninger Cold and Sinus SolutionALLIUM CEPA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLANenningers Naturals, LLC1e26b25c-5d93-4f69-aa9e-a187abd6d0352025-12-25WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
unii: 451W47IQ8X
GoodEarth Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution LLC1c4ec3cb-b7a4-73c9-e063-6394a90afeda2025-12-24WarningsExact identifier
unii: F5UM2KM3W7
tazza HAND SANITIZERBENZALKONIUM CHLORIDETazza Brands East Inc.327b9971-808d-ff93-e063-6394a90adce42025-12-24WarningsExact identifier
unii: F5UM2KM3W7
CLEANZ ECO BAMBOO WIPESWIPESMcF Holdings LLCeb85292a-41a3-67b0-e053-2a95a90ab4612025-12-24WarningsExact identifier
unii: F5UM2KM3W7
ZEHN ANTISEPTIC SANITIZING WIPESBENZALKONIUM CHLORIDEZehn Wipes39771493-978e-18b6-e063-6294a90a42662025-12-24WarningsExact identifier
unii: F5UM2KM3W7
MG DermaFoamBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.4a43a605-f333-4c76-a476-476a9cc2e13a2025-12-23WarningsExact identifier
unii: F5UM2KM3W7
Sipa HAND SANITIZING WIPESBENZALKONIUM CHLORIDESipa Holdings USA, Inc.2c47f1a8-4416-fd21-e063-6394a90ae1672025-12-23WarningsExact identifier
unii: F5UM2KM3W7
tazza HAND SANITIZER KING WIPESBENZALKONIUM CHLORIDETazza Brands East, Inc.1c7d3d7b-64ca-4f91-e063-6294a90a04a72025-12-23WarningsExact identifier
unii: F5UM2KM3W7
ActivMendARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS, NATRUM MURATICUMCearna, Inc.baefc5d4-a7e4-4ba2-e053-2995a90a4b862025-12-23WarningsExact identifier
unii: 451W47IQ8X
Hand Sanitizer Solution 101BENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.81fa10d3-6dbb-4a72-bfff-2dd795f949682025-12-23WarningsExact identifier
unii: F5UM2KM3W7
MG DermaWashBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.0bb37363-418f-46c7-8c39-9ef9aa5023f72025-12-23WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial FoamBENZALKONIUM CHLORIDESC Johnson Professional USA Inc.df36ccda-b9cb-41ba-8d4d-56ec447e63df2025-12-23WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Liquid HandBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.ea0a5970-e95f-4090-bbe3-7df9e04393b52025-12-23WarningsExact identifier
unii: F5UM2KM3W7
MG DermaCleanN/AMorgan Gallacher Inc.ed3d983e-0a6e-4de4-832a-0020f77110112025-12-23WarningsExact identifier
unii: F5UM2KM3W7
MG DermaSanN/AMorgan Gallacher Inc.d4c0de39-8570-4a05-a5e3-3752545ed95f2025-12-23WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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