FDA.reportPublic FDA data

Clotrimazole

Product NDC
51672-2158
11-digit product format
516722158
Labeler code
51672
Product ID
51672-2158_5353c019-612d-669e-e063-6294a90ab75f
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-23
Substance
CLOTRIMAZOLE
Active strength
1 g/mL
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
IngredientStrength
CLOTRIMAZOLE1 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13a14d3c-bfce-42b5-8463-4ec69e94774eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2158-1Clotrimazole10 mL in 1 BOTTLESOLUTION104
51672-2158-1Clotrimazole1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2158-1ML - Milliliter51672-2158f0efb906-a14a-4d46-a97f-ffe051818ede12025-02-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2158CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, 2 package rows20240925_13a14d3c-bfce-42b5-8463-4ec69e94774e.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 20 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER TINEA VERSICOLOR CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3db832f4-630d-72a2-e063-6394a90a08dc2026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEChain Drug Consortium, LLC5f9edcf9-b99e-65a2-e053-2a91aa0af5652026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Consortium, LLC5fafc16d-7257-fc88-e053-2991aa0a67c42026-02-12WarningsExact identifier
application number: M005
Kerova Miconazole NitrateMICONAZOLE NITRATEGuangzhou Bixiaoyu Trading Co., Ltd.3b8b5547-f8d1-9e48-e063-6294a90af4292026-02-12WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLCa980ff33-2b6d-3065-e053-2995a90ae9742026-02-11WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4a8265c5-9c69-a36a-e063-6294a90ab2922026-02-11WarningsExact identifier
application number: M005
Tuymec FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.4a983b42-9723-7a3a-e063-6394a90ae7b22026-02-11WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT SPRAYCVS Pharmacy1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c2026-02-10WarningsExact identifier
application number: M005
Kerova ANTIFUNGALCLOTRIMAZOLEGuangzhou Bixiaoyu Trading Co., Ltd.4a7b48cf-72c3-be63-e063-6394a90a1efe2026-02-10WarningsExact identifier
application number: M005
Kerova ClotrimazoleANTIFUNGALGuangzhou Bixiaoyu Trading Co., Ltd.4a7b9658-f411-299d-e063-6394a90af9ce2026-02-10WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC3b1209fc-9d6b-2f55-e063-6394a90ac2ad2026-02-10WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC0fdd1658-5759-8a42-e063-6394a90a72712026-02-10WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4a633da8-dcba-349c-e063-6294a90a77022026-02-09WarningsExact identifier
application number: M005
Fungus Master Antifungal TreatmentMICONAZOLE NITRATEEbanel Laboratories, Incf7b011b2-11e5-46f1-afed-89f438985e002026-02-09WarningsExact identifier
application number: M005
OSIMOON Toenail Fungus TreatmentTOENAIL FUNGUS TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4a7061a9-8ba2-72b8-e063-6294a90a4d9a2026-02-09WarningsExact identifier
application number: M005
CLOTRIMAZOLE 1%CLOTRIMAZOLEPHARMACY CHOICE INC43852cfb-6d28-e54f-e063-6394a90aa0902026-02-08WarningsExact identifier
application number: M005
ASSIELF ANTIFUNGAL PENUNDECYLENIC ACIDShenzhen Yuanbang International Logistics Co., Ltd4a5d8e86-6401-7556-e063-6394a90acce12026-02-08WarningsExact identifier
application number: M005
Dryello Dual Action Relief for Athlete FootTOLNAFTATEProPedix, Inc.359478dd-02c9-05e5-e063-6294a90a41ed2026-02-06WarningsExact identifier
application number: M005
HEALMUSZ ClotrimazoleCLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a326159-a6a7-c1d6-e063-6294a90a3b892026-02-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWal-Mart Stores, Inc.17d0486e-e8b5-3afe-e063-6394a90aa3842026-02-04WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-2158-1516722158011 BOTTLE in 1 CARTON (51672-2158-1) / 10 mL in 1 BOTTLE1 bottle2024-09-23NoNoCurrent