FDA.reportPublic FDA data

clotrimazole

Product NDC
68071-3395
11-digit product format
680713395
Labeler code
68071
Product ID
68071-3395_1d79b80a-e64c-7d7d-e063-6294a90a82bd
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-03
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-3395-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-3395-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-3395-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-3395-31332a3947898…d4bfe170f9cd…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54241254-1d9a-346a-e054-00144ff8d46cAvailable 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-25Perrigo Clotrimazole Cream USP, 1% Drug Facts
2023-01-30Perrigo Clotrimazole Cream USP, 1% Drug Facts
2021-02-12Perrigo Clotrimazole Cream USP, 1% Drug Facts
2021-01-29Perrigo Clotrimazole Cream USP, 1% Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3395-3clotrimazole30 g in 1 BOXCREAM304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3395CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240726_54241254-1d9a-346a-e054-00144ff8d46c.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 3 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HANCHOBIT Lemon Turmeric Kojic Acid BrighteningGLYCERINHANCHOYEANBIOTEC Co.,Ltd.2ded8f31-d72a-d123-e063-6294a90a28562025-11-27WarningsExact identifier
application number: M014
XIMONTH Wart RemoverGLYCERINShantou Ximonth Biotechnology Co., Ltd.337d4d37-c2d6-44d3-e063-6294a90a77ce2025-11-26WarningsExact identifier
application number: M014
Swimmers EarCLEARCANALNeilmed Pharmaceuticals Inc.43778b02-e90b-36b7-e063-6394a90ab62b2025-11-13WarningsExact identifier
application number: M014
Hand SanitizerALCOHOLCharlotte Products Ltd.1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa2025-10-28WarningsExact identifier
application number: M014
Carbamide peroxide 6.5%EARWAX REMOVAL KITAllegiant Health54515e9d-2225-4875-a1cf-a24a823300dd2025-10-28WarningsExact identifier
application number: M014
OFTAL-MYCIN LUBRICANT OPHTHALMICLIGHT MINERAL, WHITE PETROLATUMGRANDALL DISTRIBUTING, LLC298db04a-21a9-e46e-e063-6294a90acee22025-10-27WarningsExact identifier
application number: M014
Debrox Swimmers EarISOPROPYL ALCOHOLMedtech Products Inc.b5d57c7b-8315-4260-967e-38fdd54e2a9c2025-10-23WarningsExact identifier
application number: M014
Family Care Earwax RemovalCARBAMIDE PEROXIDEUnited Exchange Corp.958741f5-47c1-339c-e053-2a95a90a3f5f2025-10-22WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEGeiss, Destin & Dunn, Inc31ea324f-a9a1-7865-e063-6294a90a92e82025-09-19WarningsExact identifier
application number: M014
blue goo NERVE EASE Pain RELIEF Topical AnalgesicLIDOCAINE HCL 4%, MENTHOL 1%Garcoa, Inc.619d5c87-636c-407d-909e-c38512dcd5532025-09-10WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEA-S Medication Solutions8d6f1769-eb44-4bde-b3fa-3ff4658b7dd12025-09-03WarningsExact identifier
application number: M014
AuralytCARBAMIDE PEROXIDEMenper Distributors, Inc95920b87-941f-48cb-850c-40d2735596d42025-07-22WarningsExact identifier
application number: M014
hydrocortisoneHYDROCORTISONENuCare Pharmaceuticals,Inc.a0fde5c9-afb2-76a9-e053-2995a90af3e82025-07-21WarningsExact identifier
application number: M014
Healthy EarsCARBIDE PEROXIDEVitamex USA, Corp25953441-cd8e-5038-e063-6294a90ae4012025-06-23WarningsExact identifier
application number: M014
WaxRx Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEDOCTOR EASY MEDICAL PRODUCTS, LLC7e08cd86-7ae4-7d12-e053-2991aa0a4cba2025-05-01WarningsExact identifier
application number: M014
Meijer Earwax Removal DropsCARBAMIDE PEROXIDEMeijer Distribution Inc900108c6-0324-644a-e053-2a95a90a3b2b2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal KitCARBAMIDE PEROXIDEWarner Tech-care Products, LLC5851c1f6-c15b-447c-b495-3707e7a12bdb2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal DropsCARBAMIDE PEROXIDEWarner Tech-care Products, LLC1c97783b-dcdf-4f95-8516-0d7f197cbc272025-02-28WarningsExact identifier
application number: M014
TopCare Earwax Removal KitCARBAMIDE PEROXIDETOPCO ASSOCIATES LLC890cc9b6-41a5-480a-bc94-45c8d4fdeef32025-02-28WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal Aid DropsCARBAMIDE PEROXIDEOaktree Products Inc2922dde2-d082-437b-8f51-4a91ced20a582025-02-28WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 10 MG/ML Topical CreamSCD54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 1 % Topical CreamSY54241254-1d9a-346a-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3395-36807133950330 g in 1 BOX (68071-3395-3) 30 g2017-07-120000-00-00NoNoCurrent