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
Label	Manufacturer	Effective date	Type
OTOVEL - Arbor Pharmaceuticals \| Laboratorios Salvat \| The Ritedose Corporation	Arbor Pharmaceuticals \| Laboratorios Salvat \| The Ritedose Corporation	2019-09-12	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24338-080-14	2022-01-28	C162847	48780-1	d6a99b39-ec5a-a426-e053-dadaa90af4c2	These 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 NDC	Product	Description	Form	Quantity	SPL version
24338-080-14	OTOVEL	14 in 1 POUCH	SOLUTION	14	3
24338-080-14	OTOVEL	1 in 1 CARTON	SOLUTION	1	3
24338-080-25	OTOVEL	0.25 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	0.25	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24338-080	OTOVEL ((CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE)) SOLUTION [ARBOR PHARMACEUTICALS]	3	Legacy NDC, 3 package rows	20191018_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 26 of 26 · 503 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Fluocinolone Acetonide Topical	FLUOCINOLONE ACETONIDE TOPICAL	Actavis Pharma, Inc.	98dfd7a4-2208-4637-acf5-080a5813a433	2016-08-01	Adverse reactions	Exact identifier unii: 0CD5FD6S2M
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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