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 85 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pro Formance Plum Perfection Antibacterial Foam S oapBENZALKONIUM CHLORIDEPro-Link, Inc.6bdc6f78-5ecd-4de7-9457-eda580c3a3e02024-12-19WarningsExact identifier
unii: F5UM2KM3W7
PRO-LINK Antibacterial Plum Perfection Foam So apBENZALKONIUM CHLORIDEPro-Link, Inc.f1d7ff55-2b95-44a7-86dd-8e6f39ed7cf52024-12-19WarningsExact identifier
unii: F5UM2KM3W7
SMART Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDESoutheastern Paper Group, Inc.9cb5d5df-9f41-4e19-b937-b983bfdf737c2024-12-19WarningsExact identifier
unii: F5UM2KM3W7
EXTENDED CARE Antimicrobial Plum Foam HandwashBENZALKONIUM CHLORIDETRIPLE A SUPPLIES, INC.8edc666c-1d7d-4f9e-8a30-2e9fbf43209a2024-12-19WarningsExact identifier
unii: F5UM2KM3W7
BRIGHTON PROFESSIONAL Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEStaples845f4281-408c-47b4-bbf0-4f248deadc352024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Elevate TF Foam Skin Care Advance Antibacterial Foam Hand CleanerBENZALKONIUM CHLORIDETriple S a.k.a Standardized Sanitation Systems, Inc7d031478-17b8-4cca-b04e-e63970c20bcc2024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Reliable Luxury Foam Antimicrobial Handwash Citrus Floral ScentBENZALKONIUM CHLORIDEVeritiv Operating Companyb5a5e487-dc83-4ae2-b508-346b4dc8ceb12024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEWaxie Sanitary Supply2b7b7d69-02e3-4d2e-a088-60189fe31b4c2024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Reliable Hand So ap Antibacterial PlumBENZALKONIUM CHLORIDEVeritiv Operating Company4f6bfbda-099f-4c8e-863f-e506357f940a2024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
Instant Foam Non-alcohol PURE Hand SanitizerBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.fc557f8d-7ebe-4434-a350-602efbbb9c6e2024-12-18WarningsExact identifier
unii: F5UM2KM3W7
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
unii: 451W47IQ8X
Foaming Sanitizing HandBENZALKONIUM CHLORIDEKutol Products Company95f0af0e-7889-4c2a-9573-4242acfd66842024-12-18WarningsExact identifier
unii: F5UM2KM3W7
Foaming Advanced Antibacterial HandBENZALKONIUM CHLORIDEKutol Products Company7abc56b5-4446-4464-9b94-6c55f8bb9b742024-12-18WarningsExact identifier
unii: F5UM2KM3W7
Foaming Antibacterial Hand Wash0.13% BENZALKONIUM CHLORIDERJ Schinner9cbbd5d5-02cb-7119-e053-2995a90a19052024-12-18WarningsExact identifier
unii: F5UM2KM3W7
E2 SANITIZING HANDE2 SANITIZING HANDKUTOL PRODUCTS COMPANY70357eaf-8cd8-4c5e-b7a8-ae2fbba0ca2e2024-12-18WarningsExact identifier
unii: F5UM2KM3W7
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
unii: F5UM2KM3W7
Walgreens Saline Mist Extra StrengthSODIUM CHLORIDEWalgreen's Corporation90cbe2dc-36b6-77fb-e053-2995a90a28972024-12-18WarningsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy6f1fe980-ca09-401d-aed6-d3d3387cc49a2024-12-18WarningsExact identifier
unii: 451W47IQ8X
DurashieldBENZALKONIUM CHLORIDEAdvanced Biomedical Incorporatedb0723781-225a-46c6-907c-5c5c48f383b82024-12-18WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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