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 14 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Nat SulphNATRUM SULPHURICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb2502-509c-ddce-e063-6394a90a04cc2026-06-08WarningsExact identifier
unii: 0YPR65R21J
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc79b65fd4-16a5-42e0-b041-61d7bda0a5ff2026-06-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepackdf4a7747-8dfa-4933-b4d2-a3d85c5f74f82026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
Antibacterial Hand WashBENZALKONIUM CHLORIDERubbermaid Commercial Products LLCb71ba5ce-096e-4d56-831f-a2d208157ab72026-06-08WarningsExact identifier
unii: F5UM2KM3W7
Enriched Foam Alcohol-Free Hand SanitizerBENZALKONIUM CHLORIDERubbermaid Commercial Products LLC0a6456aa-69f7-476b-afbb-3dd69377e8b22026-06-05WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Foaming HandBENZALKONIUM CHLORIDECintas765ae77c-e48b-4996-82d1-cec8ed7c846f2026-06-05WarningsExact identifier
unii: F5UM2KM3W7
Diamond Wipes Antibacterial Hand WipesBENZALKONIUM CHLORIDEDiamond Wipes International Inc.1809b3cf-db76-83db-e063-6294a90a36812026-06-04WarningsExact identifier
unii: F5UM2KM3W7
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
BM Nat Sulph Icing SugarNATRUM SULPHURICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535b59d8-284d-1537-e063-6394a90a245e2026-06-03WarningsExact identifier
unii: 0YPR65R21J
GO HOME AND HAVEN ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEGrocery Outlet Inc.4a5ffc48-abdd-c7bb-e063-6394a90afe3a2026-06-01WarningsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8deaaaf7-3efd-4065-b29f-e5ef038030f82026-06-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
WILD CHERRY HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54f8dca9-65d0-8cac-e063-6394a90a58132026-06-01WarningsExact identifier
unii: F5UM2KM3W7
SHREK WAFFLE AND SSYRUP HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd552d95ec-f61f-0a7c-e063-6394a90a929b2026-06-01WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY SWEET STRAWBERRY HAND SANITIZING WIPESHAND SANITIZING WIPESKING KEY MBC LIFE TECHNOLOGY GROUP CO., LTD55a00eb2-af6e-0ce9-e063-6394a90aa6f52026-06-01WarningsExact identifier
unii: F5UM2KM3W7
SHREK GREEN APPLE HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd567cbd30-c709-5f64-e063-6394a90adb922026-06-01WarningsExact identifier
unii: F5UM2KM3W7
SHERK WATERMELON HAND SANITIZER WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd567dbd8c-3af6-34b4-e063-6394a90a0e232026-06-01WarningsExact identifier
unii: F5UM2KM3W7
BM BM115 DROPSBORAX, CAPSICUM, CONDURANGO, HYDRASTIS CAN, KALI PERM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBM Private Limited532302ff-e18c-de15-e063-6394a90a2b1c2026-05-31WarningsExact identifier
unii: O40UQP6WCF
Antiseptic WipeBENZALKONIUM CHLORIDEHubei Fanjian Medical Product Co.,Ltdf278cdbc-ab0a-6d6a-e053-2995a90a74af2026-05-28WarningsExact identifier
unii: F5UM2KM3W7
First Aid Antiseptic Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Fanjian Medical Product Co.,Ltdf44aa5a9-45e2-b890-e053-2a95a90a421b2026-05-28WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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