NDC 0062-5434 - MONISTAT-DERM

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: 0062-5434
Package NDCs from labels: 0062-5434-02, 0062-5434-01, 0062-5434-03
Manufacturer: Ortho Dermatological
Effective date: 2007-04-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
MONISTAT-DERM - Ortho Dermatological	Ortho Dermatological	2007-04-17	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0062-5434-01	MONISTAT-DERM	28 g in 1 TUBE	CREAM	28	2
0062-5434-02	MONISTAT-DERM	15 g in 1 TUBE	CREAM	15	2
0062-5434-03	MONISTAT-DERM	85 g in 1 TUBE	CREAM	85	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0062-5434	MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2	3 package rows	20070531_cb161d23-bc41-4cec-9e42-dfeef861d161.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2
Miconazole nitrate	ACTIVE MOIETY	VW4H1CYW1K	MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2
Benzioc acid	INACTIVE INGREDIENT		MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2
Butylated hydroxyanisole	INACTIVE INGREDIENT		MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2
Mineral oil	INACTIVE INGREDIENT		MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2
Peglicol 5 oleate	INACTIVE INGREDIENT		MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2
Pegoxol 7 stearate	INACTIVE INGREDIENT		MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]	2

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 6 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Micatin	MICONAZOLE NITRATE	WellSpring Pharmaceutical Corporation	96c56ba1-c3a8-48ce-ab58-550959485e3c	2016-04-07	Warnings	Exact identifier rxcui: 998483
F5990469-CB03-7E0C-6757-9DE067975C69			cb161d23-bc41-4cec-9e42-dfeef861d161	2007-04-17	Adverse reactions	Exact identifier spl id: F5990469-CB03-7E0C-6757-9DE067975C69 spl set id: cb161d23-bc41-4cec-9e42-dfeef861d161

Reported adverse events (FAERS/openFDA)#

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