FDA.reportPublic FDA data

NDC 58198-0013 - T8 Keto Flush

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
58198-0013
Package NDCs from labels
58198-0013-1, 58198-0013-2
Manufacturer
Elanco US Inc.
Effective date
2025-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Elanco ™ T8 Keto™ FLUSHElanco US Inc.2025-10-28PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0013-1T8 Keto Flush1 in 1 BOTTLE, PLASTICSOLUTION13
58198-0013-1T8 Keto Flush118 mL in 1 BOTTLE, PLASTICSOLUTION1183
58198-0013-2T8 Keto Flush1 in 1 BOTTLE, PLASTICSOLUTION13
58198-0013-2T8 Keto Flush355 mL in 1 BOTTLE, PLASTICSOLUTION3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0013T8 KETO FLUSH (KETOCONAZOLE) SOLUTION [ELANCO US INC.]24 package rows20230420_2fff06d2-c883-4d8a-af7a-958b5fe9746f.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 2 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetoconazoleKETOCONAZOLE CREAM, 2%Sportpharm LLCd68f090d-82ea-413f-ab76-9254a88887362026-01-19Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.482c0243-1073-f578-e063-6294a90adf5c2026-01-15WarningsExact identifier
unii: R9400W927I
KETOCONAZOLEKETOCONAZOLEStrides Pharma Science Limited6d4be760-c723-4f54-a854-12c61cf917032025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals,Inc.4578c84a-d438-6740-e063-6294a90a01512025-12-08Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLENorthstar Rx LLCc4f711dc-d0ea-4beb-9a78-b7e3594ee4be2025-12-01Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEBryant Ranch Prepack4baebcab-a237-42c0-9183-6f447a44e3712025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEGolden State Medical Supply, Inc.a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b72025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEBryant Ranch Prepacka878a39d-6d26-4ede-9667-b3e201ffc3372025-10-24Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEBryant Ranch Prepack6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf2025-10-24Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEBryant Ranch Prepack65dd4435-99f2-4383-b307-ba5bce9f1ca92025-10-24Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%Encube Ethicals, Inc.59188ef7-5bc9-4acc-bbff-8712c41e5f772025-09-09Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLESun Pharmaceutical Industries, Inc.8ca815a8-bccb-4ee2-a042-922373329cae2025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
NizoralKETOCONAZOLEKramer Laboratoriesf5c8c5b4-49bd-4dc7-8c29-8f1317c6ef882025-08-21WarningsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%A-S Medication Solutions750bcfc3-b0e4-407e-ad12-e81b183f3b002025-07-23Warnings, Adverse reactionsExact identifier
unii: R9400W927I
NizoralKETOCONAZOLEKramer Laboratories8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb62025-07-11WarningsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEGolden State Medical Supply, Inc.3e3cde4b-939f-4837-9920-bb6bb8416bd62025-07-10Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLESun Pharmaceutical Industries, Inc.39b85d6a-9133-42e6-b7f8-58f045e9b9f02025-07-07Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEAmici Pharma Inc.369f31da-d3c3-49b8-956f-f705987601642025-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.39d31bed-9caa-41bb-afdb-25fc18609c142025-04-24Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEA-S Medication Solutionsa884bad7-df8c-45de-8c4f-42034b40e4252025-04-23Adverse reactionsExact identifier
unii: R9400W927I

Reported adverse events (FAERS/openFDA)#

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