FDA.reportPublic FDA data

CVS Pharmacy

Product NDC
59779-510
11-digit product format
597790510
Labeler code
59779
Product ID
59779-510_39adf4d4-3787-8eaf-e063-6294a90a8da5
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-10
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59779-510-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59779-510-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59779-510-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59779-510-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59779-510-019bebd1f3094a…5416666fcb17…

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
CVS Pharmacy
Brand name suffix
ITCH RELIEF ANTIFUNGAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

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
68163ef4-d23d-43ac-bb52-9b4ba3cba2d0Available 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-510-012022-05-03C16284748780-19d75b9cf-e432-f424-e053-dadaa90a57ceCVS Pharmacy ANTIFUNGAL
59779-510-012020-01-31C16284748780-19d75b9cf-e432-f424-e053-dadaa90a57ceCVS Pharmacy ANTIFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-510-01CVS Pharmacy ITCH RELIEF ANTIFUNGAL15 g in 1 TUBECREAM155
59779-510-01CVS Pharmacy ITCH RELIEF ANTIFUNGAL1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
octyldodecanolINACTIVE INGREDIENT461N1O614YCVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1
waterINACTIVE INGREDIENT059QF0KO0RCVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-510CVS PHARMACY ITCH RELIEF ANTIFUNGAL (CLOTRIMAZOLE) CREAM [CVS PHARMACY]4Current NDC, Legacy NDC, 2 package rows20231011_68163ef4-d23d-43ac-bb52-9b4ba3cba2d0.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 4 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Natural Vine Fungal Nail patchesTOLNAFTATE 1%GETHSEMANE BRANCH CORPORATION57905962-0745-ceee-e063-6294a90a88dd2026-07-26WarningsExact 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
HTRCSW FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523bc484-511c-b603-e063-6394a90a55ae2026-07-21WarningsExact identifier
application number: M005
DERMFREE ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD49ab5abb-d311-505d-e063-6294a90a56162026-07-21WarningsExact identifier
application number: M005
DERMFREE FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD49aba00d-9249-b403-e063-6394a90a787d2026-07-21WarningsExact identifier
application number: M005
SKAPEMED SKIN REPAIRTOLNAFTATE 1% SKIN REPAIRJiangxi Yudexi Pharmaceutical Co., LTD4a20c32e-0551-aead-e063-6394a90a2aa72026-07-21WarningsExact identifier
application number: M005
REINREUDE MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a380945-9235-783a-e063-6294a90a094d2026-07-21WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN68163ef4-d23d-43ac-bb52-9b4ba3cba2d05
309367clotrimazole 10 MG/ML Topical CreamSCD68163ef4-d23d-43ac-bb52-9b4ba3cba2d05
309367clotrimazole 1 % Topical CreamSY68163ef4-d23d-43ac-bb52-9b4ba3cba2d05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-510-01597790510011 TUBE in 1 CARTON (59779-510-01) / 15 g in 1 TUBE1 tube2013-01-100000-00-00NoNoCurrent