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 6 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOVS MULTI-PURPOSE NAIL REPAIR	TOLNAFTATE 1% MULTI-PURPOSE NAIL REPAIR	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56df87a7-7fc2-5ba4-e063-6394a90a652b	2026-07-18	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit .liquid.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c93390-ee07-4f78-e063-6394a90add42	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit .cream.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c9d9fa-09ad-e26a-e063-6394a90a0ed9	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56cb7085-87d8-4273-e063-6394a90ac5df	2026-07-17	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL FOOT CARE	TOLNAFTATE 1% ANTIFUNGAL FOOT CARE	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b10492-894c-33e1-e063-6394a90a8c0f	2026-07-17	Warnings	Exact identifier application number: M005
Foot Choice-Nail Fungal Pen	UNDECYLENIC ACID	Foot Choice LLC	4b0036a6-8751-4f44-b6b1-5be57fa92cdc	2026-07-17	Warnings	Exact identifier application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream	2% MICONAZOLE NITRATE ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56b54359-db21-b8b4-e063-6394a90a6f8c	2026-07-16	Warnings	Exact identifier application number: M005
DRAVYNOR BALANITIS RELIEF Cream	MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b76a52-0743-4fe6-e063-6294a90a98a8	2026-07-16	Warnings	Exact identifier application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream	5% BENZOYL PEROXIDE FOLLICULITIS CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56c558fa-303f-fc52-e063-6394a90a72f0	2026-07-16	Warnings	Exact identifier application number: M005
Antifungal Ringworm Treatment Cream	MICONAZOLE NITRATE	Yunqi Cosmetics (Shenzhen) Co., Ltd	56a2ceea-c4c0-c30c-e063-6394a90a0e6a	2026-07-15	Warnings	Exact identifier application number: M005
Medi-First Antifungal Cream Miconazole Cream	MICONAZOLE	Unifirst First Aid Corporation	56a51b75-9c23-bcd2-e063-6394a90a9b12	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Tinea Treatment	CLEAR ROOT LABS TINEA TREATMENT	Aidance Scientic Inc., DBA Aidance Skincare & Topicals	56a67bad-c677-d3b7-e063-6394a90ad205	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Antifungal Treatment	CLEAR ROOT LABS ANTIFUNGAL TREATMENT	Aidance Scientific, Inc., DBA Aidance Skincare & Topicals	5696bf23-230a-5f37-e063-6294a90a7413	2026-07-15	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL NAIL Liquid	TOLNAFTATE 1% ANTIFUNGAL NAIL LIQUID	Jiangxi Yudexi Pharmaceutical Co., LTD	56b17e50-bff1-5eb0-e063-6294a90a3c08	2026-07-15	Warnings	Exact identifier application number: M005
terrasil Antifungal Cleansing Bar	CLOTRIMAZOLE	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	10a4fde0-87e1-4474-bcb5-255b0a7f1ecb	2026-07-14	Warnings	Exact identifier application number: M005
OAKDOLCHE Tea Tree Oil Antifungal	TOLNAFTATE	Nanjing Qiaotun Technology Co., Ltd.	569dee15-e68d-220e-e063-6294a90af7c5	2026-07-14	Warnings	Exact identifier application number: M005
Kimtara Nail Fungus Treatment	KIMTARA NAIL FUNGUS TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5678e260-10c4-f203-e063-6294a90a6223	2026-07-13	Warnings	Exact identifier application number: M005
Aiilo NAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25%	Guangzhou Huixue Biotechnology Co., Ltd.	5689ac31-4d23-0fcc-e063-6394a90ac75b	2026-07-13		Exact identifier application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PEN	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56519b25-f3c8-bcac-e063-6394a90af879	2026-07-11	Warnings	Exact identifier application number: M005
Joymeey FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5652a22e-7b43-3c31-e063-6294a90ae4f1	2026-07-11	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