Home NDC 80684-039 Thera plus Antifungal Clotrimazole
Product NDC 80684-039
11-digit product format 806840039
Labeler code 80684
Product ID 80684-039_08a0ce90-0c11-15f4-e063-6294a90a6ca7
Type HUMAN OTC DRUG
Nonproprietary name CLOTRIMAZOLE
Dosage form CREAM
Route TOPICAL
Labeler FOURSTAR GROUP USA, INC.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-30
Substance CLOTRIMAZOLE
Active strength 10 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 Thera plus Antifungal Clotrimazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 10 mg/g
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 309367 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 80684-039-01 Thera plus Antifungal Clotrimazole 14 g in 1 TUBE CREAM 14 2 80684-039-01 Thera plus Antifungal Clotrimazole 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-039 THERA PLUS ANTIFUNGAL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [FOURSTAR GROUP USA, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231027_1265be99-8922-4b76-bd63-19bfb42c3896.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 40 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 80684-039-01 80684003901 1 TUBE in 1 BOX (80684-039-01) / 14 g in 1 TUBE 1 tube 2022-01-30 0000-00-00 No No Current