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 38 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meridian Unwrapped Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	67d1d65a-71d4-41fc-a71c-85a28ce6de0c	2025-06-18	Warnings	Exact identifier application number: M005
Meridian Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	640df217-6982-441e-835a-dbe2031e732b	2025-06-18	Warnings	Exact identifier application number: M005
EYELID WIPES	EYELID WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	377fb842-aa78-ab2a-e063-6394a90a69f9	2025-06-13	Warnings	Exact identifier application number: M005
Lunavia Antifungal Foot Balm	ZINC UNDECYLENATE 10%	XF Agencija Limited	466f3285-9800-4219-902f-b78a713b952f	2025-06-13	Warnings	Exact identifier application number: M005
Foot Cure Antifungal Foot Balm	ZINC UNDECYLENATE	Sansar LLC	ac6075bf-cc1d-4e8a-aa13-5a85e80f34ee	2025-06-13	Warnings	Exact identifier application number: M005
Lunavia Antifungal	UNDECYLENIC ACID 25%	XF Agencija Limited	55891d2f-e2b8-4d9f-8140-dc258926ed90	2025-06-13	Warnings	Exact identifier application number: M005
TEGASOLVE TOENAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25%	Zhengzhou Hangrui Network Technology Co., Ltd.	375b0515-1b1f-23b8-e063-6294a90a9d68	2025-06-12	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE	CVS Pharmacy	979ab1d2-f184-455d-b31a-2ff2bd4592b8	2025-06-12	Warnings	Exact identifier application number: M005
Gemachlich ZuHause Fungal Nail Revitalizer	GEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZER	Guangdong Quadrant Ecological Technology Co., Ltd.	37332cdf-7171-42cc-e063-6394a90a0fcf	2025-06-10	Warnings	Exact identifier application number: M005
Eyelid Wipes	EYELID WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	36ddfa37-3913-9e48-e063-6294a90ae1be	2025-06-08	Warnings	Exact identifier application number: M005
Everywhere Flushable Wipes	EVERYWHERE FLUSHABLE WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	371be299-5aaf-b9d7-e063-6294a90a87f5	2025-06-08	Warnings	Exact identifier application number: M005
Fungus Master	MICONAZOLE NITRATE	Clinical Resolution Laboratory, Inc.	36eb334e-246b-249f-e063-6294a90ab811	2025-06-06	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE	Hudson Health LLC	8d725a50-fbe4-4a48-9cbf-f8b5c12dd647	2025-06-03	Warnings	Exact identifier application number: M005
CharmTex Lightly Scented Antibacterial	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	1c9f4bff-3f6f-4498-b8a2-7d7f49d6ad2d	2025-06-01	Warnings	Exact identifier application number: M005
DermaD ANTIFUNGAL Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	b97684ae-79d0-4208-b480-67794596ece7	2025-05-29	Warnings	Exact identifier application number: M005
Fungazol Athlete Foot	MICONAZOLE NITRATE	Rida LLC	ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7	2025-05-28	Warnings	Exact identifier application number: M005
Antifungal Boday Wash	TOLNAFTATE	CAVTECH HOLDING LLC	3619d717-fe42-412f-e063-6394a90a0384	2025-05-27	Warnings	Exact identifier application number: M005
Toenail Fungus Liquid	TOENAIL FUNGUS LIQUID	Shenzhen Earth Surface Trading Co., Ltd.	361f4c5c-7fa7-0440-e063-6294a90aad9f	2025-05-27	Warnings	Exact identifier application number: M005
help it Antiseptic	BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0b22f423-eb11-445f-a484-9326c1fe3ad5	2025-05-27	Warnings	Exact identifier application number: M005
Seacall Hydrocortisone Ointment.	SEACALL HYDROCORTISONE OINTMENT	Guangdong Quadrant Ecological Technology Co., Ltd.	3616980a-03dc-deba-e063-6394a90a6ce7	2025-05-26	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