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…`

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
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 51 · 1,015 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Defense Antifungal Medicated Bar	TOLNAFTATE	Defense Soap LLC	812d78ea-a14a-e3a2-e053-2a91aa0a6ff5	2026-09-09	Warnings	Exact identifier application number: M005
Medline	MICONAZOLE NITRATE	Medline Industries, LP	0d997d1d-8663-201f-e063-6394a90a285e	2026-09-08	Warnings	Exact identifier application number: M005
Remedy Antifungal With Olivamine	MICONAZOLE NITRATE	Medline Industries, LP	28c5183e-05b4-1754-e054-00144ff8d46c	2026-09-08	Warnings	Exact identifier application number: M005
Claravie	MICONAZOLE NITRATE 2%	Gentell LLC	5afdc429-cb44-703c-e063-6294a90a971a	2026-09-08	Warnings	Exact identifier application number: M005
Inlifay ANTIFUNGAL	MICONAZOLE NITRATE 2% ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a832f39-ac11-d8b3-e063-6394a90acb39	2026-09-06	Warnings	Exact identifier application number: M005
Noicaky FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5adcc5f7-2d47-2ad7-e063-6294a90a4848	2026-09-06	Warnings	Exact identifier application number: M005
LIFE66II ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5ab83796-0780-3b58-e063-6394a90a2e4e	2026-09-05	Warnings	Exact identifier application number: M005
FGPER Topical Antifungal Pen	UNDECYLENIC ACID	Guangzhou ChuanMa International Trading Co.,Ltd.	5abdcbff-6ab1-2f0a-e063-6294a90a57ef	2026-09-05	Warnings	Exact identifier application number: M005
Jock Itch Powder	MICONAZOLE NITRATE	Premier Brands of America Inc	5aaacc88-6752-ab47-e063-6394a90af7cd	2026-09-04	Warnings	Exact identifier application number: M005
ANTIFUNGAL BODY WASH	TOLNAFTATE	Guangzhou ChuanMa International Trading Co.,Ltd.	5a695043-f776-df5a-e063-6394a90ac274	2026-09-01	Warnings	Exact identifier application number: M005
KetoconClear Cream	KETOCONAZOLE	Guangzhou Shunfei Network Technology Co., Ltd.	5a54eebe-5b4a-28dd-e063-6294a90a607f	2026-08-31	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	InvaDerm Corporation	5a5cfed9-0587-7bef-e063-6294a90a64bf	2026-08-31	Warnings	Exact identifier application number: M005
Gembooxt RINGWORM Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangdong Quadrant Ecological Technology Co., Ltd.	464a33c3-6d16-0cfd-e063-6294a90abf4b	2026-08-27	Warnings	Exact identifier application number: M005
DrAny NAIL FUNGUS TREATMENT	UNDECYLENIC ACID, TOLNAFTATE	Hong Kong Juxin Negosyo Kag Komersyo Co., Limited	59ef412b-fc7b-0a84-e063-6394a90abf25	2026-08-26	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	7fd4037e-d350-47b7-a7d9-a43b8e366fa0	2026-08-25	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER pink dragon blossom	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	593b3fbe-a8de-1c09-e063-6294a90adc69	2026-08-24	Warnings	Exact identifier application number: M005
Okkazhie WART REMOVER	40% SALICYLIC ACID	Guangzhou Huixue Biotechnology Co., Ltd.	59c2d759-d1e9-6c9d-e063-6294a90a04db	2026-08-23	Warnings	Exact identifier application number: M005
1% ketoconazole anti dandruff	1% KETOCONAZOLE ANTI DANDRUFF SHAMPOO	Fast Sold LLC	7bb3598c-9597-4f3d-9a68-bd9565737928	2026-08-22	Warnings	Exact identifier application number: M005
JELVOXA ANTIFUNGAL	UNDECYLENIC ACID	Wuhan Ruihengjie Technology Co., Ltd.	59a2f16e-ef72-f1cb-e063-6394a90abb28	2026-08-22	Warnings	Exact identifier application number: M005
Viachs ANTIFUNGAL Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	598b7e0c-c76d-2f56-e063-6394a90a7053	2026-08-21	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