FDA.reportPublic FDA data

NDC 24338-080-25 - OTOVEL

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
24338-080
Requested NDC
24338-080-25
Package NDCs from labels
24338-080-25, 24338-080-14
Manufacturer
Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation
Effective date
2019-09-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OTOVEL - Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose CorporationArbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation2019-09-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24338-080-142022-01-28C16284748780-1d6a99b39-ec5a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OTOVEL safely and effectively. See full prescribing information for OTOVEL. OTOVEL (ciprofloxacin and fluocinolone acetonide) otic solution Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-080-14OTOVEL14 in 1 POUCHSOLUTION143
24338-080-14OTOVEL1 in 1 CARTONSOLUTION13
24338-080-25OTOVEL0.25 mL in 1 VIAL, SINGLE-DOSESOLUTION0.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-080OTOVEL ((CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE)) SOLUTION [ARBOR PHARMACEUTICALS]3Legacy NDC, 3 package rows20191018_1a7e4806-3138-4b7a-b798-a99e163ee846.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 11 of 26 · 503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDEBryant Ranch Prepackf7861aba-f199-4fe4-90cc-bebea55b3b5f2025-11-11Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack1539d6ac-b527-4ff0-afe4-083ceac655f32025-11-11Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b2025-11-10Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ciprofloxacin in DextroseCIPROFLOXACINProPharma Distribution42c758be-4d44-018a-e063-6294a90ae0412025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5E8K9I0O4U
Ciprofloxacin in DextroseCIPROFLOXACINHospira, Inc.cbbbf939-3219-4515-a48e-ca264daa4d072025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5E8K9I0O4U
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fluocinolone acetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepackf674a0c0-df04-47e8-8d3f-a370182a596a2025-10-29Adverse reactionsExact identifier
unii: 0CD5FD6S2M
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
unii: PDC6A3C0OX
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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