Home NDC 0536-1443 CLOTRIMAZOLE
Product NDC 0536-1443
11-digit product format 005361443
Labeler code 0536
Product ID 0536-1443_51921fa3-cebb-5959-e063-6294a90aaca2
Type HUMAN OTC DRUG
Nonproprietary name CLOTRIMAZOLE
Dosage form SOLUTION
Route TOPICAL
Labeler Rugby Laboratories, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-21
Substance CLOTRIMAZOLE
Active strength 1 g/100mL
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 CLOTRIMAZOLE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 1 g/100mL
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 0536-1443-70 CLOTRIMAZOLE 1 in 1 CARTON SOLUTION 1 4 0536-1443-70 CLOTRIMAZOLE 10 mL in 1 BOTTLE SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1443 CLOTRIMAZOLE SOLUTION [RUGBY LABORATORIES, INC.] 2 Current NDC, 2 package rows 20241129_2c60e631-5930-4420-886d-eb1990c720b6.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 Sample Exclude flag Status 0536-1443-70 00536144370 1 BOTTLE in 1 CARTON (0536-1443-70) / 10 mL in 1 BOTTLE 1 bottle 2024-11-21 No No Current