FDA.reportPublic FDA data

Dermatin

Product NDC
54473-096
11-digit product format
544730096
Labeler code
54473
Product ID
54473-096_30cde80e-e74e-d8f5-e063-6394a90abd48
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
Substance
CLOTRIMAZOLE
Active strength
.01 g/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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54473-096-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54473-096-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54473-096-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54473-096-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54473-096-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54473-096-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54473-096-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Dermatin
Brand name suffix
Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE.01 g/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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309367Internal RxNorm lookup
1112455Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e993fa3b-1d85-46b7-bda5-ed875be74c4eAvailable 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
2025-04-07Dermatin Antifungal
2025-01-30Dermatin Antifungal
2020-02-04Dermatin Antifungal
2020-01-31Dermatin Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-096-01DermatinAntifungal14 g in 1 TUBECREAM147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-096DERMATIN ANTIFUNGAL (CLOTRIMAZOLE) CREAM [MELALEUCA, INC.]7Current NDC, Legacy NDC, 1 package rows20250409_e993fa3b-1d85-46b7-bda5-ed875be74c4e.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 2 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Viachs ANTIFUNGAL CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.598b7e0c-c76d-2f56-e063-6394a90a70532026-08-21WarningsExact identifier
application number: M005
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-21WarningsExact identifier
application number: M005
GPPEE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.598d05bc-459d-71cf-e063-6394a90a19322026-08-21WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
application number: M005
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
application number: M005
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
application number: M005
BYT BANGYTONG FOLLICULITIS5% BENZOYL PEROXIDE FOLLICULITISShenzhen Jindali Technology Co., Ltd595363f9-6aee-93a5-e063-6394a90a0f0e2026-08-18WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEShield Line LLC9ddb13cd-34ed-2d63-e053-2a95a90ad9da2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESTOLNAFTATEYunqi Cosmetics (Shenzhen) Co., Ltd5939c492-6481-ddae-e063-6294a90a40bb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact identifier
application number: M005
APUREE Maximum Strength Athletes Foot AntifungalAPUREE MAXIMUM STRENGTH ATHLETES FOOT ANTIFUNGALGuangzhou Meixi Biotechnology Co., Ltd.593dc9a3-ae04-5642-e063-6294a90adb4b2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER Sea Salt Green HerbsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59259ea7-f1bb-9688-e063-6394a90afb3c2026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Marshmallow VanillaALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5925e9a7-eb93-c0e3-e063-6294a90ad2652026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Lychee Vanilla MilkALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA592625c8-cbc5-f864-e063-6394a90aeb9d2026-08-16WarningsExact identifier
application number: M005
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455Dermatin Antifungal 1 % Topical CreamPSNe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455clotrimazole 10 MG/ML Topical Cream [Dermatin]SBDe993fa3b-1d85-46b7-bda5-ed875be74c4e7
309367clotrimazole 10 MG/ML Topical CreamSCDe993fa3b-1d85-46b7-bda5-ed875be74c4e7
309367clotrimazole 1 % Topical CreamSYe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455Dermatin 10 MG/ML Topical CreamSYe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455Dermatin Antifungal 1 % Topical CreamSYe993fa3b-1d85-46b7-bda5-ed875be74c4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-096-015447300960114 g in 1 TUBE (54473-096-01) 14 g2018-01-010000-00-00NoNoCurrent