FDA.reportPublic FDA data

NDC 58198-0027-3 - Claro

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
58198-0027
Requested NDC
58198-0027-3
Package NDCs from labels
58198-0027-1, 58198-0027-2, 58198-0027-3, 58198-0027-4
Manufacturer
Elanco US Inc.
Effective date
2025-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CLARO™ Elanco TM (florfenicol, terbinafine, mometasone furoate)Elanco US Inc.2025-07-22PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0027-1Claro1 mL in 1 TUBE, WITH APPLICATORSOLUTION16
58198-0027-2Claro2 in 1 CARTONSOLUTION26
58198-0027-2Claro1 in 1 BLISTER PACKSOLUTION16
58198-0027-3Claro1 in 1 BLISTER PACKSOLUTION16
58198-0027-3Claro10 in 1 CARTONSOLUTION106
58198-0027-4Claro1 in 1 BLISTER PACKSOLUTION16
58198-0027-4Claro20 in 1 CARTONSOLUTION206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0027CLARO (FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE) SOLUTION [ELANCO US INC.]57 package rows20231115_9bd1d059-68a6-459f-9f79-2fcd97c952d6.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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltdd986282f-da3c-43b6-a3f6-40886d4a19152026-08-27Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATETorrent Pharmaceuticals Limited18ef90de-f74d-492f-a125-49da1875bd292026-08-06Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.831f7694-8153-4a79-a453-48020b26f0352026-07-17Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.bfe3d098-a5f8-4e5d-9fa6-eac167bad3e92026-07-17Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Kimtara Nail Fungus TreatmentKIMTARA NAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5678e260-10c4-f203-e063-6294a90a62232026-07-13WarningsExact identifier
unii: G7RIW8S0XP
DuleraMOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATEOrganon LLC8f399784-f257-4f31-b3dc-368bf2a1864d2026-07-10Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
ASMANEXMOMETASONE FUROATEOrganon LLC10b36fb2-6b0d-4f20-b197-3564d6f594b92026-07-07Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
ASMANEX HFAMOMETASONE FUROATEOrganon LLC0c6d63da-41bc-4894-bead-198e66c848ac2026-07-07Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack5eda1256-001a-4f40-b3ca-15349d5320332026-05-21Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone furoateMOMETASONE FUROATEEncube Ethicals, Inc.dae3eaea-fc17-48a2-ae30-2a68f7811bce2026-04-06Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Toenail Fungus TreatmentTERBINAFINEShenzhen Wankelai E-commerce Co., Ltd.4dc1d7f7-e4ae-c54b-e063-6394a90aa4202026-03-24WarningsExact identifier
unii: G7RIW8S0XP
Mometasone FuroateMOMETASONE FUROATESportpharm LLCf02dea3f-9e4f-4c5a-bea3-f428afca803b2026-03-19Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.ad47cceb-e471-48d6-85d6-e4a3f10e2ac62026-01-27Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEA-S Medication Solutions16e134c7-39fb-4d16-9c24-a6df438967bf2026-01-23Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepackc953bd40-8a52-4812-837a-baaf1b17b3aa2025-10-29Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack88f5622d-64da-42b7-8aa9-62a5da5ebfbb2025-10-24Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
MOMETASONE FUROATEMOMETASONE FUROATEEncube Ethicals, Inc.1ebaac16-432e-4e92-9d58-718bd76ae3682025-09-15Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack79e13e15-5bd3-48b1-877a-1cd92abbc7c52025-09-08Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack2f79063c-f7da-4e71-b054-d24b86dd386a2025-09-05Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltda12fef6b-681e-4f80-8bcd-3f01733f1a672025-07-07Warnings, Adverse reactionsExact identifier
unii: 04201GDN4R

Reported adverse events (FAERS/openFDA)#

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