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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-096-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-096-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-096-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-096-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-096-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-096-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-096-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dermatin
Brand name suffix: Antifungal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	.01 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G07GZ97H65	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e993fa3b-1d85-46b7-bda5-ed875be74c4e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-04-07	Dermatin Antifungal
2025-01-30	Dermatin Antifungal
2020-02-04	Dermatin Antifungal
2020-01-31	Dermatin Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-096-01	DermatinAntifungal	14 g in 1 TUBE	CREAM	14		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-096	DERMATIN ANTIFUNGAL (CLOTRIMAZOLE) CREAM [MELALEUCA, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20250409_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 1 of 50 · 984 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemachlich Zu Hause Vaginal Antifungal Gel	MICONAZOLE NITRATE	Guangzhou Xinhongda Trading Service Co., Ltd.	563cfb57-f10c-96a6-e063-6294a90a2b93	2026-08-06	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	7fd4037e-d350-47b7-a7d9-a43b8e366fa0	2026-08-05	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Family Dollar Services, Inc	57c20748-fdad-b73b-e063-6294a90a1c17	2026-08-04	Warnings	Exact identifier application number: M005
Gembooxt RINGWORM Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangdong Quadrant Ecological Technology Co., Ltd.	464a33c3-6d16-0cfd-e063-6294a90abf4b	2026-08-04	Warnings	Exact identifier application number: M005
YAMANGU FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5843cc12-de66-ca47-e063-6294a90ae55b	2026-08-04	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Meijer Distribution Inc	0b3eb169-b309-8c1a-e063-6294a90a726e	2026-08-03	Warnings	Exact identifier application number: M005
ProCure Antifungal Cream	MICONAZOLE NITRATE 2%	Twin Med LLC	39d55df5-8a8e-3a9b-e063-6294a90af20b	2026-08-03	Warnings	Exact identifier application number: M005
MiratiFul Nail Fungus Treatment	TOLNAFTATE	Texas MiratiFul Enterprises Inc.	35eb20e3-86d4-4bec-b572-3d5fe86ac74d	2026-08-03	Warnings	Exact identifier application number: M005
LUCKSKY Fungal Nail Renewal	UNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57a73b60-bbac-97e6-e063-6294a90ab9a9	2026-07-28	Warnings	Exact identifier application number: M005
Ponamfo ANTIFUNGAL TREATMENT PEN	UNDECYLENIC	Guangzhou Bixiaoyu Trading Co., Ltd.	57a9ccff-270b-9769-e063-6394a90a5e0c	2026-07-28	Warnings	Exact identifier application number: M005
FUNGAL NAIL PATCHES	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	5240412c-4257-8e9d-e063-6394a90a0a12	2026-07-28	Warnings	Exact identifier application number: M005
FFPMAM Antifungal Cream	FFPMAM ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	57b7cf61-d4cd-53f7-e063-6394a90afc54	2026-07-28	Warnings	Exact identifier application number: M005
Youggle WART REMOVER	SALICYLIC ACID	Guangzhou Huixue Biotechnology Co., Ltd.	57a3744e-316c-8a3d-e063-6294a90a15d1	2026-07-27	Warnings	Exact identifier application number: M005
antifungal pen	ANTIFUNGAL PEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5756256e-ed2b-4e13-e063-6294a90a1e0f	2026-07-24	Warnings	Exact identifier application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PEN	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	4d59116a-bcd0-9ed4-e063-6394a90a6dbd	2026-07-24	Warnings	Exact identifier application number: M005
SERYNTH MULTI-PURPOSE FUNCUS	TOLNAFTATE 1% MULTI-PURPOSE FUNCUS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a6ea0c9-1495-8ede-e063-6294a90ad093	2026-07-23	Warnings	Exact identifier application number: M005
HELPS WITH NAGELPILZ	TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID	Shanghai Honghui Chuang Intelligent Technology Co., Ltd	55753a4a-a4d0-a183-e063-6394a90acf11	2026-07-22	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit .liquid.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	5719942d-6b10-612e-e063-6294a90a4fe9	2026-07-21	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL Oil	UNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4ff57d2d-5e74-a995-e063-6394a90a3f9a	2026-07-21	Warnings	Exact identifier application number: M005
WERPEKA FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4f7a8273-b7af-d532-e063-6394a90aa63a	2026-07-21	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309367	clotrimazole 1 % Topical Cream	PSN	e993fa3b-1d85-46b7-bda5-ed875be74c4e	7
1112455	Dermatin Antifungal 1 % Topical Cream	PSN	e993fa3b-1d85-46b7-bda5-ed875be74c4e	7
1112455	clotrimazole 10 MG/ML Topical Cream [Dermatin]	SBD	e993fa3b-1d85-46b7-bda5-ed875be74c4e	7
309367	clotrimazole 10 MG/ML Topical Cream	SCD	e993fa3b-1d85-46b7-bda5-ed875be74c4e	7
309367	clotrimazole 1 % Topical Cream	SY	e993fa3b-1d85-46b7-bda5-ed875be74c4e	7
1112455	Dermatin 10 MG/ML Topical Cream	SY	e993fa3b-1d85-46b7-bda5-ed875be74c4e	7
1112455	Dermatin Antifungal 1 % Topical Cream	SY	e993fa3b-1d85-46b7-bda5-ed875be74c4e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54473-096-01	54473009601	14 g in 1 TUBE (54473-096-01)	14 g	2018-01-01	0000-00-00	No	No	Current