NDC 0062-5437-01 - MONISTAT 3

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: 0062-5437
Requested NDC: 0062-5437-01
Package NDCs from labels: 0062-5437-01
Manufacturer: ORTHO PHARMACEUTICAL CORPORATION
Effective date: 2006-12-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
MONISTAT 3 - ORTHO PHARMACEUTICAL CORPORATION	ORTHO PHARMACEUTICAL CORPORATION	2006-12-31	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0062-5437-01	MONISTAT 3	3 in 1 PACKAGE	SUPPOSITORY	3		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0062-5437	MONISTAT 3 (MICONAZOLE NITRATE) SUPPOSITORY [ORTHO PHARMACEUTICAL CORPORATION]	1	1 package rows	20070111_A1CD682A-FA73-491D-B276-8C96D801B083.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
miconazole nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	MONISTAT 3 (MICONAZOLE NITRATE) SUPPOSITORY [ORTHO PHARMACEUTICAL CORPORATION]	1
miconazole	ACTIVE MOIETY	7NNO0D7S5M	MONISTAT 3 (MICONAZOLE NITRATE) SUPPOSITORY [ORTHO PHARMACEUTICAL CORPORATION]	1
hydrogenated vegetable oil	INACTIVE INGREDIENT		MONISTAT 3 (MICONAZOLE NITRATE) SUPPOSITORY [ORTHO PHARMACEUTICAL CORPORATION]	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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Miconazole 3	MICONAZOLE NITRATE	Safeway	191e448b-0410-4102-82ae-a3387b27b227	2021-02-04	Warnings	Exact identifier rxcui: 992765
Miconazole Nitrate	MICONAZOLE NITRATE	Actavis Pharma, Inc.	aa9e250b-f317-42cb-b8d2-e85de56f4ef7	2020-10-21	Adverse reactions	Exact identifier rxcui: 992765
A1CD682A-FA73-491D-B276-8C96D801B083			A1CD682A-FA73-491D-B276-8C96D801B083	2006-12-31	Adverse reactions	Exact identifier spl id: A1CD682A-FA73-491D-B276-8C96D801B083 spl set id: A1CD682A-FA73-491D-B276-8C96D801B083

Reported adverse events (FAERS/openFDA)#

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