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 21 of 243 · 4,850 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ed5f-ed98-ebeb-e063-6294a90a2e8d2026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry CremeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5598c831-3986-00a5-e063-6394a90a1e662026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple SplashETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55982f73-7baa-26a7-e063-6394a90ab74b2026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry CrumbleETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC55981d2a-d4de-af08-e063-6294a90a4b7c2026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti CupcakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5597ff1f-b134-0beb-e063-6394a90a39a12026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread CakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5598d6ca-39f6-ca2a-e063-6394a90abc0e2026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha MistETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559832ca-df92-0c2d-e063-6294a90ab66f2026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5599605b-28f0-a534-e063-6394a90a72132026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin CreamETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559987c0-7abd-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
application number: M003
MISTIFY STRAWBERRE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5740a2ed-e77d-3f41-e063-6394a90aec032026-07-01WarningsExact identifier
application number: M003
MISTIFY VANILLA HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574ba9b9-b44d-b014-e063-6394a90af7682026-07-01WarningsExact identifier
application number: M003
MISTIFY COTTON CANDY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bcf4f-ad36-5ede-e063-6294a90a0eab2026-07-01WarningsExact identifier
application number: M003
MISTIFY COCONUT HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd57539bdd-641d-3c27-e063-6394a90af84a2026-07-01WarningsExact identifier
application number: M003
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.562f4499-f3b7-4d9e-b022-61172176c8832026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
unii: 7TQO7W3VT8
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEHudson Health LLC42789576-0ab4-1afb-e063-6294a90a1d272026-06-30WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared PlumETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5572d336-f953-90ac-e063-6394a90a2d4d2026-06-30WarningsExact identifier
application number: M003
McKesson Alcohol Prep PadISOPROPYL ALCOHOLMcKesson Medical-Surgicala8e759f3-91b1-44ae-960a-3a6cd4f746ce2026-06-30WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
Tinted Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationf3c1c8a3-6b34-46cf-845e-c89db8f096f12026-06-30WarningsExact identifier
application number: M003
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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