Home NDC 83474-003 Clotrimazole (Topical Solution), 1%
Product NDC 83474-003
11-digit product format 834740003
Labeler code 83474
Product ID 83474-003_46f2ddcb-401f-9ed7-e063-6394a90a7a63
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form SOLUTION
Route TOPICAL
Labeler Puro Pharma Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-15
Substance CLOTRIMAZOLE
Active strength 10 mg/mL
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 Clotrimazole (Topical Solution), 1%
Listing expiration 2026-12-31 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 83474-003-34 Clotrimazole (Topical Solution), 1% 10 mL in 1 BOTTLE, DROPPER SOLUTION 10 2 83474-003-34 Clotrimazole (Topical Solution), 1% 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83474-003 CLOTRIMAZOLE (TOPICAL SOLUTION), 1% (CLOTRIMAZOLE) SOLUTION [PURO PHARMA INC.] 1 Current NDC, 2 package rows 20240415_cb424fa8-3ed5-45cd-b03f-64675584b34e.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 Marketing start Sample Exclude flag Status 83474-003-34 83474000334 1 BOTTLE, DROPPER in 1 CARTON (83474-003-34) / 10 mL in 1 BOTTLE, DROPPER 2024-04-15 No No Current