FDA.reportPublic FDA data

NDC 70121-1574-01 - Dyural 80 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
70121-1574
Requested NDC
70121-1574-01
Package NDCs from labels
70121-1574-1, 70121-1574-5, 70121-1574-01
Manufacturer
Asclemed USA, Inc.
Effective date
2026-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dyural 80 Kit - Asclemed USA, Inc.Asclemed USA, Inc.2026-01-08HUMAN PRESCRIPTION DRUG LABEL
Methylprednisolone acetate - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2025-12-15HUMAN PRESCRIPTION DRUG LABEL
Dyural 80 Kit - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
Dyural 80-LM - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
Dyural 80-LM - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-10-05HUMAN PRESCRIPTION DRUG LABEL
Dyural 80 LM-C - Asclemed USA, Inc.Asclemed USA, Inc.2024-07-01HUMAN PRESCRIPTION DRUG LABEL
Methylprednisolone acetate - A-S Medication SolutionsA-S Medication Solutions2024-06-03HUMAN PRESCRIPTION DRUG LABEL
Methylprednisolone acetate - REMEDYREPACK INC.REMEDYREPACK INC.2021-04-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1574-1Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION116
70121-1574-1Methylprednisolone acetate1 in 1 CARTONINJECTION, SUSPENSION116
70121-1574-5Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION116
70121-1574-5Methylprednisolone acetate25 in 1 CARTONINJECTION, SUSPENSION2516
70121-1574-1Dyural 80 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL11
70121-1574-1Dyural 80 Kit1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL11
70121-1574-1Dyural 80-LM1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL5
70121-1574-1Dyural 80-LM1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL5
70121-1574-1Dyural 80-LM1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL2
70121-1574-1Dyural 80 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL2
70121-1574-1Dyural 80-LM1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL2
70121-1574-1Dyural 80 Kit1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1574METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 4 package rows20250108_d944240d-2c19-46ba-ad4f-3fbee7b8629c.zip
70121-1574DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC20241008_e9f7f923-e7f9-4c52-b56d-914d800c1acf.zip
70121-1574DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]5Current NDC, Legacy NDC20241008_c4071146-7d89-4c3a-9278-389d801cf66d.zip
70121-1574DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, Legacy NDC20250102_01ca2f07-9c84-e418-e063-6294a90ac760.zip
70121-1574DYURAL 80-LM (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, Legacy NDC20250102_01ca7a2d-e8cb-c063-e063-6294a90ae7f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1574-1ML - Milliliter70121-157468b0e5e7-e814-4c98-a6e5-02085339b85812020-08-06
70121-1574-5ML - Milliliter70121-157458ac78fc-2bd4-458a-8aa3-f905f328b61812020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ADYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Methylprednisolone AcetateACTIVE INGREDIENT43502P7F0PDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
BupivacaineACTIVE MOIETYY8335394RODYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
IodineACTIVE MOIETY9679TC07X4DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
LidocaineACTIVE MOIETY98PI200987DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RDYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]1

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 1 of 255 · 5,086 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Chlorhexidine Gluconate Oral RinseCHLORHEXIDINE GLUCONATE ORAL RINSEAtlantic Biologicals Corp.583986f1-1cce-21c3-e063-6394a90aed1f2026-09-10Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242026-09-10Warnings, Adverse reactionsExact identifier
application number: ANDA203082
rxcui: 1737761
unii: V13007Z41A
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
unii: V13007Z41A
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
unii: V13007Z41A
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsExact identifier
application number: M003
rxcui: 797730
unii: 85H0HZU99M
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
application number: M003
unii: ND2M416302
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
application number: M003
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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