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 30 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIBACTERIALBENZALKONIUM CHLORIDETopco Associates LLC463f3a53-921a-65cb-e063-6394a90ab4f22026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Tork Hand Washing Antibacterial FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC0f72f0cb-9e8e-43bb-862e-0024771ece1b2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Tork Hand Sanitizing Alcohol-Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCc9761e9d-21d5-4dcd-8e31-bb722c5178912026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand SanitizerBENZALKONIUM CHLORIDE 0.1%W/WGeorgia-Pacific Consumer Products LPd4575f18-d96c-465d-8580-650ee7df18f62026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Pacific Blue UltraBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LP7ea3f69f-e150-4beb-af1e-04ffc5a3b7952026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial with Moisturizers, Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LPb68252e4-ac4d-49e5-9f21-5f97c860e8f02026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial with Moisturizers, Tranquil AloeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LPb5a2429f-7a31-424d-8174-12dff6d87a7d2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Pacific Blue Ultra Antimicrobial Pacific CitrusBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LP4fc3122a-16c0-4e2c-aebb-b266857781172026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Terramed Just Think Comfort Armor Antibacterial Cleansing BarBENZALKONIUM CHLORIDERida LLC68e59a77-6a0c-42e2-a6a9-1353470d2e082026-02-04WarningsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEPermatexcfd3279e-9584-49d7-bf4b-6ef00d501d9b2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
TobramycinTOBRAMYCINNuCare Pharmaceuticals,Inc.b119bfa5-33b0-84eb-e053-2995a90a2cad2026-02-04Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
RoyceDerm Antibacterial Body WashBENZALKONIUM CHLORIDE 0.13%RoyceDerm LLC4a0c66b1-5a6f-b9b9-e063-6294a90a3d772026-02-04WarningsExact identifier
unii: F5UM2KM3W7
0.9 percentsalineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd487cb4fc-2e0b-020f-e063-6294a90a45262026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
Hand WashBENZALKONIUM CHLORIDEDemoulas Super Markets, Inc3fe61130-9ec2-4e71-b147-320a81c4344c2026-02-03Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Escudo Ultra-Protect OriginalBENZALKONIUM CHLORIDEIndelpa, Inc1cd4c38f-8156-bd74-e063-6394a90a9f562026-02-03WarningsExact identifier
unii: F5UM2KM3W7
Escudo Ultra-Protect Soft CareBENZALKONIUM CHLORIDEIndelpa, Inc.1cc4b68b-dceb-3fab-e063-6294a90ab1122026-02-03WarningsExact identifier
unii: F5UM2KM3W7
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
unii: F5UM2KM3W7
Mold, Yeast and DustACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEANaturalCaree0f53f47-acd9-43e2-a7a2-2a500bc9dc1b2026-02-03WarningsExact identifier
unii: 0YPR65R21J

Reported adverse events (FAERS/openFDA)#

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