NDC 58198-0013-1 - 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
Requested NDC
58198-0013-1
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 1 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%REMEDYREPACK INC.ea56cddf-94c9-46b6-8791-995b741cfbd72026-09-01Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
unii: R9400W927I
Gembooxt Ketoconazole 1% Medicated ShampoosKETOCONAZOLEGuangdong Quadrant Ecological Technology Co., Ltd.49965e91-43c3-65d7-e063-6294a90abaec2026-08-27WarningsExact identifier
unii: R9400W927I
1% ketoconazole anti dandruff1% KETOCONAZOLE ANTI DANDRUFF SHAMPOOFast Sold LLC7bb3598c-9597-4f3d-9a68-bd95657379282026-08-22WarningsExact identifier
unii: R9400W927I
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
unii: R9400W927I
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
unii: R9400W927I
KETOCONAZOLEKETOCONAZOLEAmerisyn LLC1d598696-c6f3-4b7c-ad73-949d2089df352026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Gemachlich ZuHause Ketoconazole 1% Anti-dandruff ShampoosKETOCONAZOLEGuangzhou Xinhongda Trading Service Co., Ltd.5792eff5-632e-3664-e063-6394a90a8ae32026-07-27WarningsExact identifier
unii: R9400W927I
KETOCONAZOLEKETOCONAZOLEPD-Rx Pharmaceuticals, Inc.f162e616-21b4-49b1-b437-15e21001a6f02026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Cysndra Ketoconazole 1% Medicated ShampoosKETOCONAZOLEGuangzhou Xinhongda Trading Service Co., Ltd.55ee7358-dfc1-b600-e063-6394a90a49d82026-07-06WarningsExact identifier
unii: R9400W927I
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals, Inc.53492ad1-baca-a7f6-e063-6294a90a29902026-06-02Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf82026-05-14Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%Preferred Pharmaceuticals Inc.abc2446c-cdc2-48fe-80f2-cf0038d2a85e2026-05-14Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Ketoconazole CreamKETOCONAZOLE CREAMDirect_Rxf422aaa8-3cce-5989-e053-2a95a90a52052026-03-17Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.4ca9a661-fa39-ab7f-e063-6294a90aed142026-03-10WarningsExact identifier
unii: R9400W927I
iShanCare Balanitis CleansingISHANCARE BALANITIS CLEANSINGShenzhen Ishan Technology Co., Ltd3ca20a09-0a55-6f38-e063-6294a90a44be2026-02-12WarningsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEANI Pharmaceuticals, Inc.00c1cac8-a865-4583-aaba-3a0f21fb31e62026-01-29Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCcad7c647-34a9-4e4e-83b3-8d78e58f588f2026-01-28Warnings, Adverse reactionsExact identifier
unii: R9400W927I

Reported adverse events (FAERS/openFDA)#

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