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 49 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Evercare Antifungal Treatment Super Absorbent Powder	MICONAZOLE NITRATE	PANEFFORT, LLC	f91910f3-b461-43a4-9120-fda69483fffa	2023-10-26	Warnings	Exact identifier application number: M005
Thera plus Antifungal Clotrimazole	CLOTRIMAZOLE	FOURSTAR GROUP USA, INC.	1265be99-8922-4b76-bd63-19bfb42c3896	2023-10-26	Warnings	Exact identifier application number: M005
Thera plus Antifungal Tolnaftate	TOLNAFTATE	FOURSTAR GROUP USA, INC.	c628dda8-7a6d-5f3a-e053-2995a90a35f8	2023-10-26	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	e1789944-3a41-4c86-b173-3a6993ae2141	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Impregnated	POVIDONE IODINE	Jianerkang Medical Co., Ltd	14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Impregnated	POVIDONE IODINE	Jianerkang Medical Co., Ltd	b82cea56-b09f-411d-a6cf-c53b3ce0e3b6	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	78131b57-1ffc-4eb8-821e-f7bb73300fe9	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	eb30e5de-9074-4760-8e92-e1d1c127227d	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	0bd3de76-b726-41f1-87bc-14ab8a1eca8e	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Prep Pad	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	be85ec5b-eb49-4f1a-a87d-5c9705a20f23	2023-10-22	Warnings	Exact identifier application number: M005
EVERLIT CARE Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	579c1ab5-50b4-4b5a-a189-c1e2827d0c3a	2023-10-14	Warnings	Exact identifier application number: M005
Micomitin Antifungal	CLOTRIMAZOLE	PureTek Corporation	dd05f5f9-2412-1295-e053-2995a90acb96	2022-02-14	Warnings	Exact identifier application number: M005
Micatin	MICONAZOLE NITRATE	WellSpring Pharmaceutical Corporation	96c56ba1-c3a8-48ce-ab58-550959485e3c	2016-04-07	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