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 15 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Wal-Mart Stores, Inc	af4d4e9e-8678-3a80-e053-2995a90a677f	2026-04-22	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Wal-Mart Stores, Inc	af4ebb3b-041e-30dd-e053-2995a90a8d2d	2026-04-22	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Wal-Mart Stores, Inc	af4dd045-ca51-42b9-e053-2a95a90a0327	2026-04-22	Warnings	Exact identifier application number: M005
4oz	MICONAZOLE	Nabrace LLC	4f912a20-e0f7-23c1-e063-6294a90a55d6	2026-04-18	Warnings	Exact identifier application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete Feet	NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET	Nabrace LLC	4fc3ddc8-08a2-ae50-e063-6294a90a1e07	2026-04-18	Warnings	Exact identifier application number: M005
SimplyVital Antifungal Clotrimazole	CLOTRIMAZOLE	Alpha Plants Inc	44881106-3ab4-4103-9c48-1da435ab5b13	2026-04-16	Warnings	Exact identifier application number: M005
medicated	MICONAZOLE	Nabrace LLC	4f90d8ad-33d9-0043-e063-6394a90a4466	2026-04-16	Warnings	Exact identifier application number: M005
Ingrown Nail Treatment	JALAWEF INGROWN NAIL TREATMENT	Consilii LLC	1ac2d7fc-1806-7925-e063-6294a90ad3b5	2026-04-15	Warnings	Exact identifier application number: M005
RDVHDLW Extra Strength NAIL REPAIR PEN	TOLNAFTATE, UNDECYLENIC ACID	Shenzhen Joyuflsh Technology Co.,Ltd.	4f68796c-11e1-e5f7-e063-6394a90adeb1	2026-04-14	Warnings	Exact identifier application number: M005
ProBliva Psoriasis Scalp .spray.	SALICYLIC ACID 3%	CAVTECH HOLDING LLC	4f695604-51c5-c1b7-e063-6294a90ab5ae	2026-04-14	Warnings	Exact identifier application number: M005
OSIMOON Fungal Nail Treatment	FUNGAL NAIL TREATMENT	Guangzhou Jingliang Cosmetics Co., Ltd.	4f7817db-cd71-fba9-e063-6294a90a9cdf	2026-04-14	Warnings	Exact identifier application number: M005
Quali Life ANTIFUNGAL PERSIMMON	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	4f520058-3b81-574e-e063-6294a90a2eae	2026-04-13	Warnings	Exact identifier application number: M005
Quali Life ANTIFUNGAL CHARCOAL	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	4f538041-e2f1-4a5f-e063-6294a90a54cf	2026-04-13	Warnings	Exact identifier application number: M005
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.	CREAM AND SOAP	RoyceDerm LLC	4f4ef2d0-98fa-e791-e063-6394a90a7045	2026-04-12	Warnings	Exact identifier application number: M005
Nailtific Daytime Treatment Antifungal Pen Refill	NAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILL	Guangzhou Meixi Biotechnology Co., Ltd.	4257ee32-0d8f-08d4-e063-6294a90a4a89	2026-04-11	Warnings	Exact identifier application number: M005
Nailtific Nighttime Antifungal Renewal Pen Refill	TOLNAFTATE	Guangzhou Meixi Biotechnology Co., Ltd.	42634fc7-d0c7-4813-e063-6294a90a702d	2026-04-11	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Chain Drug Marketing Association Inc	1a4f4d10-6782-ddb4-e063-6294a90ac206	2026-04-09	Warnings	Exact identifier application number: M005
Extra Strength Toenail Renewal Solution	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eed68e6-6814-0181-e063-6394a90a888e	2026-04-08	Warnings	Exact identifier application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PEN	TOLNAFTATE, UNDECYLENIC ACID	Guangzhou Borderless Technology Co., Ltd.	4eefbef4-7643-dca4-e063-6394a90a72c1	2026-04-08	Warnings	Exact identifier application number: M005
ZYNTHIX	UNDECYLENIC ACID SOLUTION	Shenzhen Siwei Yijiu Trading Co., Ltd.	4ef4a167-f673-efb4-e063-6294a90a3026	2026-04-08	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