Myco Nail A Antifungal Solution

Product NDC: 52083-242
11-digit product format: 520830242
Labeler code: 52083
Product ID: 52083-242_ec997f56-367c-4e57-a2c0-22d4403ae1ad
Type: HUMAN OTC DRUG
Nonproprietary name: Undecylenic acid
Dosage form: LIQUID
Route: TOPICAL
Labeler: Kramer Novis
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-14
Substance: UNDECYLENIC ACID
Active strength: 250 mg/mL
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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52083-242-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52083-242-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52083-242-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52083-242-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52083-242-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52083-242-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52083-242-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52083-242-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Myco Nail A Antifungal Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UNDECYLENIC ACID	250 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K3D86KJ24N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998329	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
550358d7-69e8-4ea3-bcf9-d647c457287d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-11-14	Myco Nail A AntiFungal Solution
2025-11-14	Myco ® Nail A ANTI-FUNGAL Solution
2025-01-30	Myco Nail A AntiFungal Solution
2025-01-30	Myco ® Nail A ANTI-FUNGAL Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-242-30	Myco Nail A Antifungal Solution	1 in 1 CARTON	LIQUID	1		6
52083-242-30	Myco Nail A Antifungal Solution	30 mL in 1 BOTTLE	LIQUID	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-242-30	ML - Milliliter	52083-242	22e49e0f-98de-4687-b5e1-4c971c5fc238	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
UNDECYLENIC ACID	ACTIVE INGREDIENT	K3D86KJ24N	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
UNDECYLENIC ACID	ACTIVE MOIETY	K3D86KJ24N	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
BENZYL ACETATE	INACTIVE INGREDIENT	0ECG3V79ZJ	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
CHLOROXYLENOL	INACTIVE INGREDIENT	0F32U78V2Q	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
EUCALYPTOL	INACTIVE INGREDIENT	RV6J6604TK	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
PROPIONIC ACID	INACTIVE INGREDIENT	JHU490RVYR	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-242	MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]	4	Current NDC, Legacy NDC, 2 package rows	20221102_550358d7-69e8-4ea3-bcf9-d647c457287d.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 27 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Myco Nail A Antifungal Solution	UNDECYLENIC ACID	Kramer Novis	550358d7-69e8-4ea3-bcf9-d647c457287d	2025-12-04	Warnings	Exact identifier application number: M005 ndc (product): 52083-242
Tea Tree Oil Antifungal Soaps	TOLNAFTATE	Nanjing Jitaxing Technology Co., LTD	4517d3a7-9144-b91d-e063-6294a90a4990	2025-12-03	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	23ca78c0-16a9-455c-99a7-b9a9a3affa60	2025-12-03	Warnings	Exact identifier application number: M005
Gembooxt Nail Fungus Solution	GEMBOOXT NAIL FUNGUS SOLUTION	Guangdong Quadrant Ecological Technology Co., Ltd.	44f5c1bc-decf-beef-e063-6394a90ab562	2025-12-02	Warnings	Exact identifier application number: M005
WELMATE Clotrimazole Topical Solution	CLOTRIMAZOLE	YYBA CORP	dc5bac4a-938c-4678-89ac-a899440c6a3c	2025-12-02	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	TOLNAFTATE	CARDINAL HEALTH 110 dba LEADER	bb14825c-518d-bfba-e053-2995a90a7889	2025-12-02	Warnings	Exact identifier application number: M005
ProCure Antifungal	MICONAZOLE NITRATE 2%	Twin Med LLC	3d375325-ddad-f1e1-e063-6394a90a679f	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	0a6cb1f7-a2a2-46a2-ae63-d205318996f0	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Miconazole Nitrate	MICONAZOLE NITRATE	New World Imports, Inc	bed775be-8bcb-44c2-9b9f-8bb25b4b2453	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Tolnaftate	TOLNAFTATE	New World Imports, Inc	cabf84c1-1500-46fe-b226-b16d4a0666c7	2025-12-01	Warnings	Exact identifier application number: M005
Trimazole	CLOTRIMAZOLE	Trifluent Pharma LLC	a3bafc52-1404-4e0b-84c1-e28bffcb091e	2025-12-01	Warnings	Exact identifier application number: M005
APUREE Pure Nailtific Extra-Strength Fungal Nail Patches	APUREE PURE NAILTIFIC EXTRA-STRENGTH FUNGAL NAIL PATCHES	Guangzhou Meixi Biotechnology Co., Ltd.	445354d8-bec2-0fd9-e063-6394a90a0099	2025-11-24	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	VALU MERCHANDISERS, CO	f4abb499-6893-9efb-e053-2995a90a33ed	2025-11-24	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE ATHLETES FOOT POWDER SPRAY TALC FREE	VALU MERCHANDISERS, CO	9ac97d4a-169b-49ff-aa34-ccb5b43726a1	2025-11-24	Warnings	Exact identifier application number: M005
Tolnafate	FOOT ODOR CONTROL POWDER SPRAY	VALU MERCHANDISERS, CO	51b69b0f-d63f-4fe0-87e6-722f95568761	2025-11-24	Warnings	Exact identifier application number: M005
Miconazole Nitrate Antifungal Powder	MICONAZOLE NITRATE ANTIFUNGAL POWDER	Marlex Pharmaceuticals, Inc.	de4f703c-39e9-855e-e053-2a95a90a6ea9	2025-11-21	Warnings	Exact identifier application number: M005
Odor-Eaters Athletes Foot	TOLNAFTATE	Blistex Inc.	20d795d1-2345-4d4f-8439-07ad11ff8f65	2025-11-21	Warnings	Exact identifier application number: M005
Derman Antifungal	ZINC UNDECYLENATE	Compania Internacional de Comercio, S.A.P.I de C.V.	0129d801-90f6-49fd-857f-27d6ba9fc66c	2025-11-19	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	9afb964c-9b88-4701-adcf-7070e25cb6c1	2025-11-19	Warnings	Exact identifier application number: M005
AU KAH CHUEN ANTIFUNGAL	CLOTRIMAZOLE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	3a262bcd-e6c0-4554-ab1c-9c861f90e190	2025-11-18	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K3D86KJ24N	UNDECYLENIC ACID	112-38-9	UNDECYLENIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998329	undecylenic acid 25 % Topical Solution	PSN	550358d7-69e8-4ea3-bcf9-d647c457287d	6
998329	undecylenic acid 250 MG/ML Topical Solution	SCD	550358d7-69e8-4ea3-bcf9-d647c457287d	6
998329	undecylenic acid 25 % Topical Solution	SY	550358d7-69e8-4ea3-bcf9-d647c457287d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-242-30	52083024230	1 BOTTLE in 1 CARTON (52083-242-30) / 30 mL in 1 BOTTLE	1 bottle	2014-01-14	0000-00-00	No	No	Current