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 21 of 26 · 503 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEThe Kroger Co.318dea21-2656-36a3-e063-6294a90ac9c42024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Equaline Redness Relief Lubricant Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc31a30b00-9f4b-717a-e063-6394a90a8a872024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Harris Teeter Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLC.31a3d575-10f1-5feb-e063-6294a90ac4782024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Discount Drug Mart Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.31a98e6c-42df-6b56-e063-6294a90a35642024-01-01WarningsExact identifier
unii: PDC6A3C0OX
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
unii: PDC6A3C0OX
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
unii: PDC6A3C0OX
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: PDC6A3C0OX
Meijer Maximum Redness Relief and LubricantGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9feb1818-c79b-23bf-e053-2995a90a10842023-12-22WarningsExact identifier
unii: PDC6A3C0OX
Meijer Redness ReliefGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9fea4e43-7525-bb66-e053-2a95a90acee92023-12-22WarningsExact identifier
unii: PDC6A3C0OX
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Eye Drops Maximum Redness Relief 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company949d4a4d-b0f8-81f8-e053-2995a90a818d2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Redness Relief Eye Drops 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company94a0d08a-a6db-1088-e053-2995a90ab4fd2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Target Eye Drops Maximum Redness Relief EyeGLYCERIN, NAPHAZOLINE HYDROCHLORIDETarget Corporation1b26cd3b-4a05-4623-b320-01f22b3106ff2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Cleareyes Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINLil' Drug Store Products, Inc.39e4ab2b-ae12-4339-b219-109cf0f7f06a2023-12-15WarningsExact identifier
unii: PDC6A3C0OX
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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