FDA.reportPublic FDA data

NDC 0859-2412 - Claro Otic Solution

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
0859-2412
Package NDCs from labels
0859-2412-01, 0859-2412-02, 0859-2412-03
Manufacturer
Bayer HealthCare, LLC Animal Health Division
Effective date
2021-01-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Claro Otic Solution - Bayer HealthCare, LLC Animal Health DivisionBayer HealthCare, LLC Animal Health Division2021-01-21PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLORFENICOLACTIVE INGREDIENT9J97307Y1HCLARO OTIC SOLUTION ((FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)) SOLUTION [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]1
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RCLARO OTIC SOLUTION ((FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)) SOLUTION [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]1
TERBINAFINEACTIVE INGREDIENTG7RIW8S0XPCLARO OTIC SOLUTION ((FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)) SOLUTION [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]1
FLORFENICOLACTIVE MOIETY9J97307Y1HCLARO OTIC SOLUTION ((FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)) SOLUTION [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]1
MOMETASONEACTIVE MOIETY8HR4QJ6DW8CLARO OTIC SOLUTION ((FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)) SOLUTION [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]1
TERBINAFINEACTIVE MOIETYG7RIW8S0XPCLARO OTIC SOLUTION ((FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)) SOLUTION [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]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 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.