Antifungal Cream

Product NDC
68001-475
11-digit product format
680010475
Labeler code
68001
Product ID
68001-475_097d120f-44a3-3b38-e063-6294a90a8e70
Type
HUMAN OTC DRUG
Nonproprietary name
antifungal
Dosage form
CREAM
Route
TOPICAL
Labeler
BluePoint Laboratories
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-25
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

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 packagepackage68001-47568001-475-46DDiscontinued by firm2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Antifungal Cream
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
b4c4240f-f84c-ec5e-e053-2a95a90aa082Available 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
68001-475-45Antifungal Cream1 in 1 CARTONCREAM15
68001-475-45Antifungal Cream14.2 g in 1 TUBECREAM14.25
68001-475-46Antifungal Cream1 in 1 CARTONCREAM15
68001-475-46Antifungal Cream15 g in 1 TUBECREAM155
68001-475-47Antifungal Cream28.4 g in 1 TUBECREAM28.45
68001-475-47Antifungal Cream1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-475-45GM - Gram68001-4756063da07-113a-43f8-9344-e8bd6787119912021-08-05
68001-475-47GM - Gram68001-475f1c22db1-ee32-49fa-8a52-cdcba1edd83112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-475ANTIFUNGAL CREAM (ANTIFUNGAL) CREAM [BLUEPOINT LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20231118_b4c4240f-f84c-ec5e-e053-2a95a90aa082.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 36 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolnaftate AntifungalTOLNAFTATESTRATEGIC SOURCING SERVICES LLC97ffb6fd-5670-4783-b805-88fe9e43ca962025-07-15WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESTRATEGIC SOURCING SERVICES LLC966a1000-3b08-4f2c-a9f8-568f2524b7172025-07-15WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATEAmerisource Bergena3c9b783-4a36-46b3-a0dc-0696907eaebb2025-07-15WarningsExact identifier
application number: M005
Clotrimazole Jock ItchCLOTRIMAZOLERite Aid Corporationc2875c05-eedd-4546-89dd-ed88b3f28abd2025-07-14WarningsExact identifier
application number: M005
Signature Care Jock ItchCLOTRIMAZOLESafeway Inc.9ec8b527-0f03-4433-8d33-635e746fdf792025-07-14WarningsExact identifier
application number: M005
RingwormCLOTRIMAZOLEWalgreen Company42ee3ebc-4d8f-4ece-950d-5636699a2b2e2025-07-11WarningsExact identifier
application number: M005
Walgreens Jock ItchCLOTRIMAZOLEWalgreen Company2d6d7ac8-9f62-4670-9aa2-e73c29034de92025-07-11WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEWalgreen Company5cc1c525-8ff2-429b-97ec-129e0100db472025-07-11WarningsExact identifier
application number: M005
Live Better AntifungalCLOTRIMAZOLEThe Great Atlantic & Pacific Tea Company7b2e44b9-b1ac-48c8-994d-4e9682ec8bad2025-07-11WarningsExact identifier
application number: M005
CVS Antifungal RingwormCLOTRIMAZOLECVS Pharmacy638c7fd6-cec4-4c14-9f49-de56587211992025-07-11WarningsExact identifier
application number: M005
CVS Pharmacy ITCH RELIEF ANTIFUNGALCLOTRIMAZOLECVS Pharmacy68163ef4-d23d-43ac-bb52-9b4ba3cba2d02025-07-11WarningsExact identifier
application number: M005
HEB AntifungalCLOTRIMAZOLEH E B8f07dc5a-cfa8-4a57-ac90-552a7c947cc52025-07-11WarningsExact identifier
application number: M005
Publix athletic footCLOTRIMAZOLEPublix Super Markets Inca51679aa-5dd4-404a-98cf-cc620e233cb82025-07-11WarningsExact identifier
application number: M005
Terrasil Athletes Foot AntiFungal Treatment MaxCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfce478a0-05f5-4606-82ce-c8dd095df2112025-07-11WarningsExact identifier
application number: M005
Terrasil Tinea Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsd0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa2025-07-11WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLECVS Pharmacy8731f4ca-84a0-4325-895b-35bf8e2ff0e12025-07-08WarningsExact identifier
application number: M005
CAREONE ClotrimazoleCLOTRIMAZOLEAmerican Sales Company68915156-8927-4ace-9497-5e510d1edcca2025-07-08WarningsExact identifier
application number: M005
Clotrimazole Athletes FootCLOTRIMAZOLEWal-Mart Stores, Inc.1440cf4d-e075-4137-a8ee-f41bd449c9982025-07-08WarningsExact identifier
application number: M005
Good Neighbor Pharmacy ClotrimazoleCLOTRIMAZOLEAmerisourceBergenadf75d72-26a7-4f4e-bba5-34a6fbe2a4cc2025-07-08WarningsExact identifier
application number: M005
Kroger ATHLETES FOOTCLOTRIMAZOLEKroger Company9e623f18-3e00-4952-b347-337d83fe3acb2025-07-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNb4c4240f-f84c-ec5e-e053-2a95a90aa0825
309367clotrimazole 10 MG/ML Topical CreamSCDb4c4240f-f84c-ec5e-e053-2a95a90aa0825
309367clotrimazole 1 % Topical CreamSYb4c4240f-f84c-ec5e-e053-2a95a90aa0825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-475-45680010475451 TUBE in 1 CARTON (68001-475-45) / 14.2 g in 1 TUBE1 tube2020-11-250000-00-00NoNoCurrent
68001-475-46680010475461 TUBE in 1 CARTON (68001-475-46) > 15 g in 1 TUBE1 tube2020-11-250000-00-00NoNoCurrent
68001-475-47680010475471 TUBE in 1 CARTON (68001-475-47) / 28.4 g in 1 TUBE1 tube2020-11-250000-00-00NoNoCurrent