Home NDC 83004-012 ANTIFUNGAL MEDICATED BODY WASH
Product NDC 83004-012
11-digit product format 830040012
Labeler code 83004
Product ID 83004-012_2efe0156-5331-f3dc-e063-6394a90ae105
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE
Dosage form GEL
Route TOPICAL
Labeler Rida LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-06
Substance TOLNAFTATE
Active strength 1 g/100g
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 ANTIFUNGAL MEDICATED BODY WASH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2689792 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 83004-012-01 ANTIFUNGAL MEDICATED BODY WASH 56 g in 1 BOTTLE, PLASTIC GEL 56 3 83004-012-02 ANTIFUNGAL MEDICATED BODY WASH 113 g in 1 BOTTLE, PLASTIC GEL 113 3 83004-012-03 ANTIFUNGAL MEDICATED BODY WASH 226 g in 1 BOTTLE, PLASTIC GEL 226 3 83004-012-04 ANTIFUNGAL MEDICATED BODY WASH 453 g in 1 PACKAGE GEL 453 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83004-012 ANTIFUNGAL MEDICATED BODY WASH (TOLNAFTATE) GEL [RIDA LLC] 3 Current NDC, 4 package rows 20250227_e3ebce6f-88ca-4100-ac79-d300f44e4891.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 Sample Exclude flag Status 83004-012-01 83004001201 56 g in 1 BOTTLE, PLASTIC (83004-012-01) 56 g 2024-06-06 No No Current 83004-012-02 83004001202 113 g in 1 BOTTLE, PLASTIC (83004-012-02) 113 g 2024-06-06 No No Current 83004-012-03 83004001203 226 g in 1 BOTTLE, PLASTIC (83004-012-03) 226 g 2024-06-06 No No Current 83004-012-04 83004001204 453 g in 1 PACKAGE (83004-012-04) 453 g 2024-06-06 No No Current