Home NDC 73581-449 WELMATE Clotrimazole Topical Solution
Product NDC 73581-449
11-digit product format 735810449
Labeler code 73581
Product ID 73581-449_44fa6931-24c0-42a7-e063-6394a90aa50f
Type HUMAN OTC DRUG
Nonproprietary name CLOTRIMAZOLE
Dosage form LIQUID
Route TOPICAL
Labeler YYBA CORP
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-19
Substance CLOTRIMAZOLE
Active strength 10 mg/mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 WELMATE Clotrimazole Topical Solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309370 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73581-449-00 WELMATE Clotrimazole Topical Solution 1 in 1 BOX LIQUID 1 3 73581-449-00 WELMATE Clotrimazole Topical Solution 10 mL in 1 BOTTLE, DROPPER LIQUID 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73581-449 WELMATE CLOTRIMAZOLE TOPICAL SOLUTION (CLOTRIMAZOLE) LIQUID [YYBA CORP] 1 Current NDC, 2 package rows 20240222_dc5bac4a-938c-4678-89ac-a899440c6a3c.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 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73581-449-00 73581044900 1 BOTTLE, DROPPER in 1 BOX (73581-449-00) / 10 mL in 1 BOTTLE, DROPPER 2024-02-19 No No Current