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 8 of 26 · 503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
unii: PDC6A3C0OX
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
unii: PDC6A3C0OX
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
unii: PDC6A3C0OX
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
unii: PDC6A3C0OX
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Gaezoa CreamPOTERIUM OFFICINALE ROOT EXTRACT, CAMELLIA SINENSIS LEAF, ELAEAGNUS GLABRA EXTRACTBIOHERB Co., Ltd.4731b85c-bbd5-fd26-e063-6394a90a6a732025-12-30WarningsExact identifier
unii: PDC6A3C0OX
GoodSense Redness Relief PlusGLLYCERIN, NAPHAZOLINE HYDROCHLORIDEGeiss, Destin & Dunn, Inc.9b37250f-9bdf-574e-e053-2a95a90a013e2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
CVS Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HCICVS Pharmacy, Inc.f70f9fc4-4022-336e-e053-6394a90a4d072025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: PDC6A3C0OX
DG Maximum Strength Redness ReliefGLYCERIN, NAPHAZOLINE HCLDolgencorp, Inc9cb261ed-b708-1189-e053-2a95a90a547d2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Winco Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWinCo Foods, LLCff3651d4-42ce-4db1-a318-15f7592baf862025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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