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 86 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DG Health Maximum Strength Pain Relieving CleansingBENZALKONIUM CL, LIDOCAINE HCLDollar General Corporation64f69315-77a3-49dc-940d-efd7a29c66452024-12-17WarningsExact identifier
unii: F5UM2KM3W7
SAN X E2BENZALKONIUM CHLORIDEAmerisan, LLCd6e2f275-4609-24e6-e053-2995a90a8dd32024-12-16WarningsExact identifier
unii: F5UM2KM3W7
KleenLine Essentials E2 Free and Clear Antibacterial HandSoapBENZALKONIUM CHLORIDEBrady Industries29681aee-d7a3-17e8-e063-6294a90a5ae92024-12-16WarningsExact identifier
unii: F5UM2KM3W7
KleenLine Essentials Antibacterial Foaming HandSoapBENZALKONIUM CHLORIDEBrady Industries2968ddad-598b-163b-e063-6294a90a57222024-12-16WarningsExact identifier
unii: F5UM2KM3W7
Soft Care Instant Hand Sanitizer AFBENZALKONIUM CHLORIDEDiversey, Inc.16846c69-b7e6-4ebe-b142-f1bf9b62c3282024-12-16WarningsExact identifier
unii: F5UM2KM3W7
Appeal Antibacterial Hand WashBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.357a4349-76f5-47b8-ae72-b1dbe19938862024-12-16WarningsExact identifier
unii: F5UM2KM3W7
SoftenSure Antimicrobial FoamBENZALKONIUM CHLORIDEBest Sanitizers, Inc29286676-a07f-78e3-e063-6294a90a4ac52024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Primory Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.3459ed2b-9440-4139-9262-f055d3980af72024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Mentholatum Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEThe Mentholatum Company365c93bc-2299-4e69-ba3a-69414bfe78d72024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Signatry Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.ab87b641-fdcd-4a64-8c38-f2def849a4312024-12-13WarningsExact identifier
unii: F5UM2KM3W7
PURELL Foodservice HEALTHY SP 0.5pct BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, Inc.a3061ef3-e4d7-49dd-b4cf-f71bf20dbfd22024-12-13WarningsExact identifier
unii: F5UM2KM3W7
PURELL Healthcare HEALTHY SP 0.5 BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, Inc.6f1b969e-77b9-46fd-8642-ffce87a73ecb2024-12-13WarningsExact identifier
unii: F5UM2KM3W7
GOJO Antibacterial Plum Foam Handwash with Biobased contentBENZALKONIUM CHLORIDEGOJO Industries, Inc.38abc40e-2f61-4436-9814-8586bf7d1acb2024-12-13WarningsExact identifier
unii: F5UM2KM3W7
Tobramycin Inhalation Solution PakTOBRAMYCINGenericus, Inc.dad13445-f591-4829-96f9-1598ba03dff82024-12-13Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Excelon Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, Inc.2e2883e2-dc0d-4b35-93be-514b85339c632024-12-12WarningsExact identifier
unii: F5UM2KM3W7
PURELL Hand Sanitizing Wipes Clean Refreshing ScentBENZALKONIUM CHLORIDE WIPEGOJO Industries, Inc.4a8862cd-682f-4419-8f0c-794bae243e652024-12-12WarningsExact identifier
unii: F5UM2KM3W7
PURELL Hand Sanitizing WipesBENZALKONIUM CHLORIDEGOJO Industries, Inc.70e0e729-4203-4258-97d3-2ad2eabf41e62024-12-12WarningsExact identifier
unii: F5UM2KM3W7
Gyne-ChordHOMEOPATHIC LIQUIDEnergetix Corporation2e9fda67-6bda-4bac-aec8-065f0bf582702024-12-11WarningsExact identifier
unii: 0YPR65R21J
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 451W47IQ8X
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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