FDA.reportPublic FDA data

NDC 80425-0348-01 - Dyural 40 Kit

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
80425-0348
Requested NDC
80425-0348-01
Package NDCs from labels
80425-0348-1, 80425-0348-01
Manufacturer
Advanced Rx Pharmacy 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
Dyural 40 Kit - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4887-17Dyural 40 Kit10 mL in 1 VIAL, PLASTICINJECTION10 mL1 mL in 1mL2
0409-4888-02Dyural 40 Kit10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION10 mL9 mg in 1mL2
70121-1573-5Dyural 40 Kit25 in 1 CARTONINJECTION, SUSPENSION40 mg in 1mL2
70121-1573-5Dyural 40 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL40 mg in 1mL2
80425-0348-1Dyural 40 Kit1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0348DYURAL 40 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 5 package rows20250102_01ca16de-ab2e-4e19-e063-6394a90a0510.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0348-1EA - Each80425-0348ba076026-5416-442a-a3ad-ed31cc18be7012023-09-05

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 96 of 239 · 4,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
safeHands Hand Sanitizer Fragrance FreeBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC0e7af9f7-80a1-4347-89c4-7d9c8b55d65d2025-11-29WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC5376a031-b657-47d4-bf41-c393fdec040b2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC2298e131-3b0c-4104-bf48-5c366d763d452025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCbe8b96a2-c4a2-41f8-959b-0fe349cff37e2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCb35cb3d0-1a2d-4ffc-a32e-faa2ca1312ee2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCcef2d3d4-bd5f-4f2a-bb2d-5292b78501c12025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC90d6fe21-7b41-4429-8c03-4d35e66a3b292025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC87aaabb6-d121-464f-993d-5182de13d49e2025-11-28WarningsExact identifier
application number: M003
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED5c10e3a1-7806-40c7-afd2-4c420e1418232025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
rxcui: 1724884
rxcui: 1724787
rxcui: 1725078
rxcui: 1725082
rxcui: 1724786
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED02d0e5f1-5fab-4420-b673-785fd81d7ae22025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1012404
rxcui: 1012396
unii: 7TQO7W3VT8
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
application number: M003
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEBrookfield Pharmaceuticals, LLC.e824ba5b-3289-5ad4-e053-2995a90acc202025-11-27Warnings, Adverse reactionsExact identifier
rxcui: 1737761
rxcui: 1737566
unii: V13007Z41A
Walgreen Maximum strength pain relieving cleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWALGREENS CO.9a0443a2-f1a9-482d-b5ee-abe983e4ae322025-11-26WarningsExact identifier
application number: M003
unii: V13007Z41A
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
unii: V13007Z41A
WalgreensFIRST AID ANTISEPTICWalgreensae731d28-8530-4dd0-aef7-b25f784b47772025-11-26WarningsExact identifier
application number: M003
unii: V13007Z41A
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEA-S Medication Solutions82b377ee-0e3e-4cb9-a644-f45434c21cca2025-11-26Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: 1Q73Q2JULR
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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