Home NDC 85248-101 SERYNTH Clotrimazole
Product NDC 85248-101
11-digit product format 852480101
Labeler code 85248
Product ID 85248-101_5729a4d3-1503-946f-e063-6294a90a6384
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole1% Clotrimazole
Dosage form CREAM
Route TOPICAL
Labeler Jiangxi Yudexi Pharmaceutical Co., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-08
Substance CLOTRIMAZOLE
Active strength 1 g/100g
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 SERYNTH Clotrimazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 1 g/100g
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 85248-101-01 SERYNTH Clotrimazole 30 g in 1 BOTTLE CREAM 30 1 85248-101-02 SERYNTH Clotrimazole 60 g in 1 BOTTLE CREAM 60 1
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 51 · 1,004 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 85248-101-01 85248010101 30 g in 1 BOTTLE (85248-101-01) 30 g 2026-02-08 No No Current 85248-101-02 85248010102 60 g in 1 BOTTLE (85248-101-02) 60 g 2026-02-08 No No Current