Selan Antifungal

Product NDC: 0159-2500
11-digit product format: 001592500
Labeler code: 0159
Product ID: 0159-2500_43008a76-def0-9f72-e063-6294a90accdb
Type: HUMAN OTC DRUG
Nonproprietary name: Selan Antifungal
Dosage form: CREAM
Route: TOPICAL
Labeler: Trividia Manufacturing Solutions, Inc
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2003-11-05
Substance: MICONAZOLE NITRATE
Active strength: 2 g/100g
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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0159-2500-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0159-2500-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0159-2500-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0159-2500-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0159-2500-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0159-2500-04	`1332a3947898…`	`d4bfe170f9cd…`

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: Selan Antifungal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	2 g/100g

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
8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-12-16	Selan AntiFungal
2024-12-16	Selan AntiFungal
2024-01-30	Selan AntiFungal
2024-01-30	Selan AntiFungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0159-2500-04	Selan Antifungal	117 g in 1 TUBE	CREAM	117		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
DIMETHICONE 1000	INACTIVE INGREDIENT	MCU2324216	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
POLAWAX POLYSORBATE	INACTIVE INGREDIENT	Q504PL8E0V	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	SELAN ANTIFUNGAL CREAM [PJ NOYES CO. INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0159-2500	SELAN ANTIFUNGAL CREAM [TRIVIDIA MANUFACTURING SOLUTIONS, INC]	8	Current NDC, Legacy NDC, 1 package rows	20241218_8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29.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 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXTRA STRENGTH TOENAIIL RENEWAL PEN	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eea5ee7-0ef9-8d34-e063-6294a90af595	2026-04-07	Warnings	Exact identifier application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL Solution	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeaa2f0-efc7-eab3-e063-6294a90a13b3	2026-04-07	Warnings	Exact identifier application number: M005
Extra Strength Toenail Renewal Pen	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeb59d2-3891-2e45-e063-6294a90a4fcf	2026-04-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.	CLOTRIMAZOLE 1%	RoyceDerm LLC	4e889f2b-9ea1-b1a6-e063-6394a90a4654	2026-04-03	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment Extra Strength Pen	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fbcc50-a3ac-d6d1-e063-6294a90aa2b6	2026-04-02	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT Liquid	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fc7049-e367-42bf-e063-6394a90a6f06	2026-04-02	Warnings	Exact identifier application number: M005
Fungal Nail Patches	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	299a63ad-f321-117c-e063-6394a90a3a22	2026-04-02	Warnings	Exact identifier application number: M005
Secura Antifungal Greaseless	MICONAZOLE NITRATE	Smith & Nephew Medical Ltd	9be600e4-76ec-4071-a8ec-a0b23155271d	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Bacitracin Zinc	BACITRACIN ZINC	WeCare Products LLC	5c6b3ad8-c158-4cc0-b1ba-b829b5df1284	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Antifungal	MICONAZOLE NITRATE	WeCare Products LLC	b70238eb-afcb-4e09-976f-973df249241c	2026-04-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE	Hanyang Qisheng (Shenzhen) Technology Co., Ltd.	4e85f338-ffd7-85b1-e063-6294a90a3c87	2026-04-02	Warnings	Exact identifier application number: M005
RoyceDerm Anti-Fungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	4e861073-88e8-b2f7-e063-6394a90ab94a	2026-04-02	Warnings	Exact identifier application number: M005
Miconazole Nitrate	JOCK ITCH SPRAY	CVS Pharmacy	7b70d3ea-126a-42aa-8509-b982893c710b	2026-04-01	Warnings	Exact identifier application number: M005
Fungicure Anti-Fungal Liquid	TOLNAFTATE	Kobayashi Healthcare International, Inc.	b18ee199-0659-733c-e053-2a95a90ab6b5	2026-04-01	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	CVS Pharmacy	96cc594d-85c8-4f62-bc0a-3176c8739f21	2026-04-01	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	CVS Pharmacy	a7b6bd7c-23db-43e1-92f7-e27f5f4801de	2026-04-01	Warnings	Exact identifier application number: M005
Baza Antifungal	MICONAZOLE NITRATE	Coloplast Corp	75182cb7-840a-423a-9c20-10840d6e1d65	2026-03-31	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Trifecta Pharmaceuticals Usa Llc	80217dbb-a0f0-414a-8d22-a9a346b017aa	2026-03-31	Warnings	Exact identifier application number: M005
RoyceDerm Antifungal Bar	CLOTRIMAZOLE	RoyceDerm LLC	3abdc4a8-58dd-5bd0-e063-6294a90a1bca	2026-03-31	Warnings	Exact identifier application number: M005
Critic Aid Clear AF	MICONAZOLE NITRATE	Coloplast Corp	cbc5d976-850a-476e-b179-b7a5a8675524	2026-03-31	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	8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29	9
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29	9
998483	miconazole nitrate 2 % Topical Cream	SY	8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0159-2500-04	00159250004	117 g in 1 TUBE (0159-2500-04)	117 g	2003-11-05	0000-00-00	No	No	Current