Clotrimazole

Product NDC
36800-508
Requested package NDC
36800-508-01
11-digit product format
368000508
Labeler code
36800
Product ID
36800-508_b5f02aa7-e582-40f1-a912-b43c32b64bd6
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-30
Marketing end
2026-05-30
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-50836800-508-01DDiscontinued by firm2026-08-11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-508-01Clotrimazole28 g in 1 TUBECREAM284
36800-508-01Clotrimazole1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-508CLOTRIMAZOLE CREAM [TOP CARE (TOPCO ASSOCIATES LLC)]4Current NDC, Legacy NDC, 2 package rows20241115_cdb619ea-29a3-4c17-a6ec-8ff0b2f31ab4.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 1 of 50 · 984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-06WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-05WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc57c20748-fdad-b73b-e063-6294a90a1c172026-08-04WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-04WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843cc12-de66-ca47-e063-6294a90ae55b2026-08-04WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEMeijer Distribution Inc0b3eb169-b309-8c1a-e063-6294a90a726e2026-08-03WarningsExact identifier
application number: M005
ProCure Antifungal CreamMICONAZOLE NITRATE 2%Twin Med LLC39d55df5-8a8e-3a9b-e063-6294a90af20b2026-08-03WarningsExact identifier
application number: M005
MiratiFul Nail Fungus TreatmentTOLNAFTATETexas MiratiFul Enterprises Inc.35eb20e3-86d4-4bec-b572-3d5fe86ac74d2026-08-03WarningsExact identifier
application number: M005
LUCKSKY Fungal Nail RenewalUNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.57a73b60-bbac-97e6-e063-6294a90ab9a92026-07-28WarningsExact identifier
application number: M005
Ponamfo ANTIFUNGAL TREATMENT PENUNDECYLENICGuangzhou Bixiaoyu Trading Co., Ltd.57a9ccff-270b-9769-e063-6394a90a5e0c2026-07-28WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsExact identifier
application number: M005
FFPMAM Antifungal CreamFFPMAM ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd57b7cf61-d4cd-53f7-e063-6394a90afc542026-07-28WarningsExact identifier
application number: M005
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-07-27WarningsExact identifier
application number: M005
antifungal penANTIFUNGAL PENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5756256e-ed2b-4e13-e063-6294a90a1e0f2026-07-24WarningsExact identifier
application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
application number: M005
SERYNTH MULTI-PURPOSE FUNCUSTOLNAFTATE 1% MULTI-PURPOSE FUNCUSJiangxi Yudexi Pharmaceutical Co., LTD4a6ea0c9-1495-8ede-e063-6294a90ad0932026-07-23WarningsExact identifier
application number: M005
HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd55753a4a-a4d0-a183-e063-6394a90acf112026-07-22WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION5719942d-6b10-612e-e063-6294a90a4fe92026-07-21WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
application number: M005
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-508-01368000508011 TUBE in 1 CARTON (36800-508-01) / 28 g in 1 TUBE1 tube2021-09-302026-05-30NoNoCurrent