Home NDC 49348-689 SUNMARK MICONAZOLE NITRATE
Product NDC 49348-689
11-digit product format 493480689
Labeler code 49348
Product ID 49348-689_3b276d84-5847-1694-e063-6294a90a4609
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Strategic Sourcing Services LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 1991-10-01
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SUNMARK MICONAZOLE NITRATE
Brand name suffix antifungal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998483 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49348-689-72 SUNMARK MICONAZOLE NITRATEantifungal 30 g in 1 TUBE CREAM 30 5 49348-689-72 SUNMARK MICONAZOLE NITRATEantifungal 1 in 1 CARTON CREAM 1 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-689 SUNMARK MICONAZOLE NITRATE ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [STRATEGIC SOURCING SERVICES LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241211_7c15d95a-5b89-4789-8c91-3f61d7ec7707.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 36 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49348-689-72 49348068972 1 TUBE in 1 CARTON (49348-689-72) / 30 g in 1 TUBE 1 tube 1991-10-01 0000-00-00 No No Current