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 121 of 237 · 4,728 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece368e-1c98-6275-e063-6294a90a1dec2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece74d3-fec4-55cc-e063-6394a90afda92025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece4de7-4c1c-5dde-e063-6294a90ae56e2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Jasmine ShadeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf17c6-3a97-7dc5-e063-6294a90a85c62025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Dragon FruitETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf0c05-15f2-cf9e-e063-6294a90ab8462025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Cherry BerryETHYL ALCOHOL 70%MY IMPORTS USA LLC3eced383-2f0b-3c0d-e063-6394a90afce42025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Mango PapayaETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf2280-56e6-4770-e063-6394a90a3e3c2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Ocean BreezeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf411b-2748-7296-e063-6394a90a3bec2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Petal CascadeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC3ecf4668-3ece-a665-e063-6394a90afe122025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Salted CaramelETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf534b-c865-1e80-e063-6394a90a245b2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Salted CaramelETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e93d14e-38a1-af85-e063-6394a90af14c2025-09-12WarningsExact identifier
application number: M003
JO for Him Prolonger with LidocaineLIDOCAINECC Wellness LLCb12dc6a3-142d-3219-e053-2995a90aead02025-09-12WarningsExact identifier
unii: V13007Z41A
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
unii: PDC6A3C0OX
AshleyBelle Moisturizing Hand Sanitizer Ocean BreezeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e927c78-3295-9484-e063-6294a90a2ed42025-09-11WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Petal CascadeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.3e92fc21-e96c-a6ac-e063-6294a90a88052025-09-11WarningsExact identifier
application number: M003
RYONCILREMESTEMCEL-L-RKNDMesoblasta4e0918f-7444-4694-adeb-d38d983456592025-09-11Warnings, Adverse reactionsExact identifier
rxcui: 797544
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: G2M7P15E5P
AshleyBelle Moisturizing Hand Sanitizer Cherry BerryETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6c959e-62cf-ec7c-e063-6294a90a0b122025-09-10WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer TransformersALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6debb9-8eeb-c82f-e063-6394a90a89f52025-09-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6e665b-78d8-bf9c-e063-6394a90a4acc2025-09-10WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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