Home NDC 44577-002 CLARUS Antifungal
Product NDC 44577-002
11-digit product format 445770002
Labeler code 44577
Product ID 44577-002_09740b13-55d0-2604-e063-6294a90a158c
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE
Dosage form SOLUTION
Route TOPICAL
Labeler Clinical Therapeutic Solutions
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-06-07
Substance TOLNAFTATE
Active strength 1 g/100mL
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 CLARUS Antifungal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313423 Internal RxNorm lookup 1299066 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44577-002-01 CLARUS Antifungal 15 mL in 1 BOTTLE SOLUTION 15 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44577-002 CLARUS ANTIFUNGAL (TOLNAFTATE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS] 6 Current NDC, Legacy NDC, 1 package rows 20231106_308a91d1-3511-4e2d-a62f-a31d77d70e06.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 Units Marketing start Marketing end Sample Exclude flag Status 44577-002-01 44577000201 15 mL in 1 BOTTLE (44577-002-01) 15 ml 2017-02-06 0000-00-00 No No Current