Micatin

Product NDC: 65197-103
11-digit product format: 651970103
Labeler code: 65197
Product ID: 65197-103_d9d5ec5c-ee44-42cd-9579-969f3ae1f166
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: WellSpring Pharmaceutical Corporation
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-06-24
Marketing end: 2026-11-30
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Current FDA listing: Yes

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: Micatin

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998483	Internal RxNorm lookup
998509	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
96c56ba1-c3a8-48ce-ab58-550959485e3c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65197-103-05	Micatin	14 g in 1 TUBE	CREAM	14		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65197-103-05	GM - Gram	65197-103	efc568b5-c1ec-4767-b2b3-a2c85664732d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]	5
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]	5
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]	5
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65197-103	MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]	11	Current NDC, Legacy NDC, 1 package rows	20240711_96c56ba1-c3a8-48ce-ab58-550959485e3c.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 10 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Beilloso Hyaluronic Acid	CLOTRIMAZOLE 1 PERCENT HYALURONIC ACID	Jiangxi Yudexi Pharmaceutical Co., LTD	4a712797-c992-dd8e-e063-6294a90a0592	2026-06-14	Warnings	Exact identifier application number: M005
Beilloso Balanitis Relief	MICONAZOLE NITRATE 2% BALANITIS RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4a71c26f-dee5-7b7f-e063-6294a90afcc1	2026-06-14	Warnings	Exact identifier application number: M005
PUVIDA FUNGAL NAIL	TOLNAFTATE 1% FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4c55fcad-c59f-9a6e-e063-6394a90a6c5f	2026-06-14	Warnings	Exact identifier application number: M005
Klipp EXTRA STRENGTH TOENAIL FUNGUS TREATMENT	KLIPP EXTRA STRENGTH TOENAIL FUNGUS TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	54430f20-72db-64f7-e063-6394a90a2cc3	2026-06-14	Warnings	Exact identifier application number: M005
Bldaxn FUNGAL NAIL RENEWZL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWZL	Jiangxi Yudexi Pharmaceutical Co., LTD	4993181e-68d5-6b91-e063-6294a90a65ce	2026-06-12	Warnings	Exact identifier application number: M005
NATUHEAL MULTI -PURPOSE TREATMENT	TOLNAFTATE 1% MULTI -PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a469862-85ab-4c24-e063-6294a90ad245	2026-06-12	Warnings	Exact identifier application number: M005
cmojsk TOENAIL FUNGUS PEN	UNDECYLENIC ACID 25% TOLNAFTATE 1% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	524bbb36-df7b-f21a-e063-6394a90ad0f1	2026-06-12	Warnings	Exact identifier application number: M005
BODYKOO NAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25% NAIL FUNGUS TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	535191e9-dc55-0c60-e063-6394a90a330f	2026-06-12	Warnings	Exact identifier application number: M005
Charmpoo Antifungal Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	5214a267-0bab-59b8-e063-6394a90adb84	2026-06-12	Warnings	Exact identifier application number: M005
EVERFERE ANTIFUNGAL	UNDECYLENIC ACID 10% ZINC UNDECYLENATE 12% ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4bc99af7-ea08-8543-e063-6294a90a44cd	2026-06-12	Warnings	Exact identifier application number: M005
nail fungus treatment	TOLNAFTATE	Guangzhou Liyan Cosmetics Technology Co., Ltd.	54ee5e53-8c99-01f8-e063-6394a90ae382	2026-06-12	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Soap.	TOLNAFTATE 1%	Trovina Co. Ltd	514fc45c-aadb-6205-e063-6394a90ae473	2026-06-11	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	53fed66b-a371-38d2-e063-6294a90a510e	2026-06-11	Warnings	Exact identifier application number: M005
SEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASH	SEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASH	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	54050e6b-a7f1-5067-e063-6394a90aebe5	2026-06-11	Warnings	Exact identifier application number: M005
Velloryn 1% Clotrimazole ANTIFUNGAL	VELLORYN 1% CLOTRIMAZOLE ANTIFUNGAL	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	540652da-f8f0-01ee-e063-6294a90a12e9	2026-06-11	Warnings	Exact identifier application number: M005
Fitcube NAIL REPAIR PEN	UNDECYLENIC ACID 25% TOLNAFTATE 1% NAIL REPAIR PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	5365268e-7845-4a91-e063-6294a90ac6bf	2026-06-10	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Walgreens Company	3858402f-783b-9292-e063-6294a90abe38	2026-06-10	Warnings	Exact identifier application number: M005
Hermon Antifungal cleansing bar	TOLNAFTATE 1%	Beautivity LLC	53cd1a2b-6ca6-c93b-e063-6394a90aaf3a	2026-06-09	Warnings	Exact identifier application number: M005
Antifungal 1% Clotrimazole Cream	ANTIFUNGAL 1% CLOTRIMAZOLE CREAM	Twincraft Inc.	29698d9e-8449-ceee-e063-6394a90a366e	2026-06-09	Warnings	Exact identifier application number: M005
Antifungal 1% Clotrimazole Cream	ANTIFUNGAL 1% CLOTRIMAZOLE CREAM	Defense Soap LLC	040264b2-8f2f-f059-e063-6294a90ad720	2026-06-09	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998509	Micatin 2 % Topical Cream	PSN	96c56ba1-c3a8-48ce-ab58-550959485e3c	11
998483	miconazole nitrate 2 % Topical Cream	PSN	96c56ba1-c3a8-48ce-ab58-550959485e3c	11
998509	miconazole nitrate 20 MG/ML Topical Cream [Micatin]	SBD	96c56ba1-c3a8-48ce-ab58-550959485e3c	11
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	96c56ba1-c3a8-48ce-ab58-550959485e3c	11
998509	Micatin 2 % Topical Cream	SY	96c56ba1-c3a8-48ce-ab58-550959485e3c	11
998509	Micatin 20 MG/ML Topical Cream	SY	96c56ba1-c3a8-48ce-ab58-550959485e3c	11
998483	miconazole nitrate 2 % Topical Cream	SY	96c56ba1-c3a8-48ce-ab58-550959485e3c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65197-103-05	65197010305	14 g in 1 TUBE (65197-103-05)	14 g	2009-06-24	2026-11-30	No	No	Current