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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnaftate	TOLNAFTATE	Sheffield Pharmaceuticals LLC	ca52af37-c3a2-414c-a24a-a37a92925133	2025-02-20	Warnings	Exact identifier application number: M005
Dr Sheffield Athletes Foot	CLOTRIMAZOLE	Sheffield Pharmaceuticals LLC	b8b8e6b2-1022-4592-91ba-3cf94c7cf318	2025-02-19	Warnings	Exact identifier application number: M005
UKVOA Toenail Fungus Treatment	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2e3cde7b-850e-f9d2-e063-6394a90adb18	2025-02-16	Warnings	Exact identifier application number: M005
UKOVA FOOT ODOR PROBIOTIC	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2de0225d-dd85-e2da-e063-6294a90a050b	2025-02-11	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes Foot Wipes	TOLNAFTATE	Cosco International, Inc.	cde656a9-7841-4a73-a2f4-f5a76a3e15c1	2025-02-06	Warnings	Exact identifier application number: M005
Silka Athletes Foot	MICONAZOLE NITRATE	Genomma Lab USA	307104a2-2df6-43b0-bf3f-f4d93d3e40f1	2025-02-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	fd7dd2eb-03a7-ef1f-e053-6294a90a8557	2025-02-04	Warnings	Exact identifier application number: M005
Molecular AF	TOLNAFTATE	Renu Laboratories, LLC	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	2025-02-03	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Papalo Group LLC	2d2c0e12-123d-75bd-e063-6394a90ae546	2025-01-31	Warnings	Exact identifier application number: M005
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	IDO PHARM	d5833c6f-81dd-6ff6-e053-2995a90ac76d	2025-01-30	Warnings	Exact identifier application number: M005
AWAS ALCOHOLSPRAY	ALCOHOL	IDO PHARM	03010837-0289-3e08-e063-6394a90a7d04	2025-01-30	Warnings	Exact identifier application number: M005
ELON Dual Defense Anti Fungal Formula	UNDECYLENIC ACID	Little Giant Holdings LLC	45c4567d-7876-6459-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M005
DCH Labs Antifungal Jock	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	fc749882-2e1e-cad3-e053-6294a90a33ca	2025-01-27	Warnings	Exact identifier application number: M005
Antifungal Pen	UNDECYLENIC ACID 25%	XF Agencija Limited	a15d4512-0fc6-424f-9dd3-ab433d9b7a26	2025-01-27	Warnings	Exact identifier application number: M005
Mata Hongos	UNDECYLENIC ACID	Vitamex USA, Corp	21ca7edb-dde3-5846-e063-6394a90a3cc0	2025-01-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	53cb4c0d-40b5-4cf3-b122-fd6dd654883f	2025-01-23	Warnings	Exact identifier application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGAL	TOLNAFTATE	Natureplex, LLC	575b8645-9166-4242-a74f-f4aa4acaaf3d	2025-01-15	Warnings	Exact identifier application number: M005
Tobcharm Antifungal Treatment Cream	ANTIFUNGAL TREATMENT CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba241cc-2767-1190-e063-6294a90ac66b	2025-01-13	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2%	MICONAZOLE NITRATE	Akron Pharma Inc.	8933f939-098a-4257-8d9c-4d5c3240e9a6	2025-01-10	Warnings	Exact identifier application number: M005
ANTI-ITCH FEMININE CARE	HYDROCORTISONE 0.5%	OL PHARMA TECH, LLC Drs PHARMACY	d6fa5ff3-ebdc-222d-e053-2a95a90a88d5	2025-01-09	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	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