SUNMARK MICONAZOLE NITRATE

Product NDC: 49348-689
11-digit product format: 493480689
Labeler code: 49348
Product ID: 49348-689_3b276d84-5847-1694-e063-6294a90a4609
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Strategic Sourcing Services LLC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1991-10-01
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: SUNMARK MICONAZOLE NITRATE
Brand name suffix: antifungal
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998483	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
7c15d95a-5b89-4789-8c91-3f61d7ec7707	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49348-689-72	2025-07-30	C162847	48780-1	3b156c62-3319-fb37-e063-e6dba90a4e07	sunmark ™ antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-689-72	SUNMARK MICONAZOLE NITRATEantifungal	30 g in 1 TUBE	CREAM	30		5
49348-689-72	SUNMARK MICONAZOLE NITRATEantifungal	1 in 1 CARTON	CREAM	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-689-72	GM - Gram	49348-689	ae015f1f-68b8-4209-b295-89bdbc8d5537	1	2013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
apricot kernel oil	INACTIVE INGREDIENT	54JB35T06A	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
glycol stearate	INACTIVE INGREDIENT	0324G66D0E	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
polyethylene glycol 300	INACTIVE INGREDIENT	5655G9Y8AQ	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-689	SUNMARK MICONAZOLE NITRATE ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [STRATEGIC SOURCING SERVICES LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241211_7c15d95a-5b89-4789-8c91-3f61d7ec7707.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
998483	miconazole nitrate 2 % Topical Cream	PSN	7c15d95a-5b89-4789-8c91-3f61d7ec7707	5
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	7c15d95a-5b89-4789-8c91-3f61d7ec7707	5
998483	miconazole nitrate 2 % Topical Cream	SY	7c15d95a-5b89-4789-8c91-3f61d7ec7707	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-689-72	49348068972	1 TUBE in 1 CARTON (49348-689-72) / 30 g in 1 TUBE	1 tube	1991-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
sunmark ™ antifungal	Strategic Sourcing Services LLC \| Sun Pharma Canada Inc.	2025-07-30	HUMAN OTC DRUG LABEL	5
Antifungal	A-S Medication Solutions	2018-01-05	HUMAN OTC DRUG LABEL	7