FDA.reportPublic FDA data

NDC 54771-1050-1 - Sileo

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
54771-1050
Requested NDC
54771-1050-1
Package NDCs from labels
54771-1050-1
Manufacturer
Zoetis Inc. | Orion Corporation
Effective date
2024-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sileo - Zoetis Inc. | Orion CorporationZoetis Inc. | Orion Corporation2024-07-18PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-1050-1Sileo3 mL in 1 SYRINGEGEL38
54771-1050-1Sileo1 in 1 CARTONGEL18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-1050SILEO (DEXMEDETOMIDINE) GEL [ZOETIS INC.]82 package rows20240814_8113cc85-cd1e-4edc-b933-51bdbd1d8b64.zip

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 1 ยท 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexmedetomidineDEXMEDETOMIDINEAvenacy Inc.eee6145b-d83f-4596-92d3-733934d8a3a42026-08-05Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DEXMEDETOMIDINEDEXMEDETOMIDINEMeitheal Pharmaceuticals Inc.8fa36783-b94d-4084-8c41-40ee641920742026-08-03Warnings, Adverse reactionsName fallback
brand name: DEXMEDETOMIDINE
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEEugia US LLC8c162541-986b-4b30-866c-b2631ba2c9752026-07-20Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEPiramal Critical Care Incc116d83f-35da-19ca-e053-2a95a90a017d2026-06-26Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEPiramal Critical Care Incb93a71ed-0f9e-1ff9-e053-2995a90a789d2026-06-03Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEWG Critical Care, LLC0d2710f2-ee47-4114-ab5c-8dca74cdcb8d2026-06-02Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEGland Pharma Limited714cc0d2-8a4c-40c0-8ef0-dcfde4c469892026-05-19Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEMylan Institutional LLCebdfe2e8-30ca-4f18-935a-41bcbbce49372026-05-18Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEProPharma Distribution42cbeadf-fea3-d2ae-e063-6394a90ad5492025-12-18Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DEXMEDETOMIDINEDEXMEDETOMIDINEProPharma Distribution42dab90e-68c1-bed1-e063-6294a90a4b0c2025-11-05Warnings, Adverse reactionsName fallback
brand name: DEXMEDETOMIDINE
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEAccord Healthcare Inc.2b9881f0-4a66-660f-e054-00144ff88e882025-02-11Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE
DexmedetomidineDEXMEDETOMIDINEMedical Purchasing Solutions, LLC12ef0602-bf07-6ddd-e063-6294a90a23c32024-03-05Warnings, Adverse reactionsName fallback
brand name: Dexmedetomidine
generic name: DEXMEDETOMIDINE

Reported adverse events (FAERS/openFDA)#

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