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…`

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 1 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Defense Antifungal Medicated Bar	TOLNAFTATE	Defense Soap LLC	812d78ea-a14a-e3a2-e053-2a91aa0a6ff5	2026-09-09	Warnings	Exact identifier application number: M005
Radthary GROIN ANTIFUNGAL Cream	MICONAZOLE NITRATE 2% GROIN ANTIFUNGAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5b1945f3-84ba-f3dc-e063-6294a90ab8a0	2026-09-09	Warnings	Exact identifier application number: M005
Medline	MICONAZOLE NITRATE	Medline Industries, LP	0d997d1d-8663-201f-e063-6394a90a285e	2026-09-08	Warnings	Exact identifier application number: M005
Remedy Antifungal With Olivamine	MICONAZOLE NITRATE	Medline Industries, LP	28c5183e-05b4-1754-e054-00144ff8d46c	2026-09-08	Warnings	Exact identifier application number: M005
Claravie	MICONAZOLE NITRATE 2%	Gentell LLC	5afdc429-cb44-703c-e063-6294a90a971a	2026-09-08	Warnings	Exact identifier application number: M005
HSENJT Antifungal Cream	MICONAZOLE NITRATE	Huizhou Haosen Trading Co., Ltd.	5aa587f5-5ddf-542a-e063-6294a90a522b	2026-09-07	Warnings	Exact identifier application number: M005
Inlifay ANTIFUNGAL	MICONAZOLE NITRATE 2% ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a832f39-ac11-d8b3-e063-6394a90acb39	2026-09-06	Warnings	Exact identifier application number: M005
Noicaky FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5adcc5f7-2d47-2ad7-e063-6294a90a4848	2026-09-06	Warnings	Exact identifier application number: M005
LIFE66II ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5ab83796-0780-3b58-e063-6394a90a2e4e	2026-09-05	Warnings	Exact identifier application number: M005
FGPER Topical Antifungal Pen	UNDECYLENIC ACID	Guangzhou ChuanMa International Trading Co.,Ltd.	5abdcbff-6ab1-2f0a-e063-6294a90a57ef	2026-09-05	Warnings	Exact identifier application number: M005
AOUGK SALICYLIC ACID WART REMOVER	SALICYLIC ACID	Guangzhou ChuanMa International Trading Co.,Ltd.	5ac88b51-b46c-5cc6-e063-6394a90af9e5	2026-09-05	Warnings	Exact identifier application number: M005
Jock Itch Powder	MICONAZOLE NITRATE	Premier Brands of America Inc	5aaacc88-6752-ab47-e063-6394a90af7cd	2026-09-04	Warnings	Exact identifier application number: M005
ANTIFUNGAL BODY WASH	TOLNAFTATE	Guangzhou ChuanMa International Trading Co.,Ltd.	5a695043-f776-df5a-e063-6394a90ac274	2026-09-01	Warnings	Exact identifier application number: M005
KetoconClear Cream	KETOCONAZOLE	Guangzhou Shunfei Network Technology Co., Ltd.	5a54eebe-5b4a-28dd-e063-6294a90a607f	2026-08-31	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	InvaDerm Corporation	5a5cfed9-0587-7bef-e063-6294a90a64bf	2026-08-31	Warnings	Exact identifier application number: M005
Gembooxt RINGWORM Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangdong Quadrant Ecological Technology Co., Ltd.	464a33c3-6d16-0cfd-e063-6294a90abf4b	2026-08-27	Warnings	Exact identifier application number: M005
DrAny NAIL FUNGUS TREATMENT	UNDECYLENIC ACID, TOLNAFTATE	Hong Kong Juxin Negosyo Kag Komersyo Co., Limited	59ef412b-fc7b-0a84-e063-6394a90abf25	2026-08-26	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	7fd4037e-d350-47b7-a7d9-a43b8e366fa0	2026-08-25	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER pink dragon blossom	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	593b3fbe-a8de-1c09-e063-6294a90adc69	2026-08-24	Warnings	Exact identifier application number: M005
Okkazhie WART REMOVER	40% SALICYLIC ACID	Guangzhou Huixue Biotechnology Co., Ltd.	59c2d759-d1e9-6c9d-e063-6294a90a04db	2026-08-23	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