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 16 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HepaparCARDUUS MARIANUS, CHELIDONIUM MAJUS, LAPPA MAJOR, TARAXACUM OFFICINALE, BOLDO, CHOLINUM, HEPAR SUIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUERCUS GLANDIUM SPIRITUS, AURUM MURIATICUM NATRONATUM, CHENOPODIUM ANTHELMINTICUMEnergique, Inc.ddbcbad9-ddb0-4ffd-a769-4de02e6698452026-05-19WarningsExact identifier
unii: 0YPR65R21J
Caring Mill BZK TowelettesBENZALKONIUM CHLORIDEFSA Store Inc.51f20e04-3efb-9dbf-e063-6394a90a4aca2026-05-18WarningsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
unii: F5UM2KM3W7
Lightning X BZK WIPEBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.5182df99-d825-376e-e063-6394a90a54352026-05-11WarningsExact identifier
unii: F5UM2KM3W7
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
tazza ECOFIT WIPESBENZALKONIUM CHLORIDETazza Brands East Inc50a83324-cc13-3668-e063-6394a90a44ed2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
unii: F5UM2KM3W7
crisp pearBENZALKONIUM CHLORIDELIDL US LLCca58d78e-a85a-da96-e053-2995a90a60a92026-05-08WarningsExact identifier
unii: F5UM2KM3W7
HIMarkBENZALKONIUM CHLORIDEApollo Health and Beauty Caref96022c6-268b-9085-e053-6294a90a0e3f2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Better Living BrandsBENZALKONIUM CHLORIDEBetter Living Brands LLCee53ceaf-8709-459b-e053-2995a90a05e02026-05-08WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS Pharmacye56e908d-a372-5f3a-e053-2a95a90ac5f62026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Gold LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care1e1459c8-0c8a-0e40-e063-6294a90a53742026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify White Tea LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d72396-2aeb-f8f3-e063-6394a90a9ec82026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify Crisp Clean LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d75a2f-8b82-924c-e063-6294a90ae09c2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One RegularBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25a7fc33-4d6a-3a67-e063-6294a90a44652026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One Crisp CleanBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b33a18-0b14-5411-e063-6294a90a31ee2026-05-08WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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