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.
| 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 |
|---|---|
| UNDECYLENIC ACID | 250 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K3D86KJ24N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 998329 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 550358d7-69e8-4ea3-bcf9-d647c457287d | Available on FDA.report |
DailyMed Product Concepts#
| 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 |
|---|---|
| 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 | 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 | 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#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Triple Antifungal | MICONAZOLE NITRATE | Advantice Health, LLC | 9a47fb1b-a41f-4c8a-8e43-7332853c308e | 2026-03-19 | Warnings | M005 |
| Antifungal | CLOTRIMAZOLE | Dynarex Corporation | 4d4cc4b4-c0b4-9e25-e063-6294a90a70b8 | 2026-03-18 | Warnings | M005 |
| Antifungal | MICONAZOLE NITRATE | Dynarex Corporation | 4d384385-f3c5-09ba-e063-6394a90aec7f | 2026-03-17 | Warnings | M005 |
| Fungi Nail Toe and Foot | TOLNAFTATE | Kramer Laboratories | e21ccb83-54ff-4605-80bf-7b4b789c7cb7 | 2026-03-17 | Warnings | M005 |
| Peunitory Fungal Nail Treatment | TOLNAFTATE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 4d2e86bc-5122-ba4a-e063-6394a90acf13 | 2026-03-16 | Warnings | M005 |
| DRMITSUI FOOT ANTIFUNGAL TREATMENT | SALICYLIC ACID | Zhenping Renren Industry Co., Ltd. | 4ce59d31-56fe-d74f-e063-6294a90a7cce | 2026-03-14 | Warnings | M005 |
| NERANTE FUNGUS NAIL PEN | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3984b-53cd-a665-e063-6394a90afe5f | 2026-03-13 | Warnings | M005 |
| FUNGAL NAIL TREATMENT | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3f0e2-b532-b89f-e063-6294a90a7e25 | 2026-03-13 | Warnings | M005 |
| BYT BANGYTONG HELPS WITH NAGELPILZ | TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID | Shenzhen Jindali Technology Co., Ltd | 49ed1cc8-e8e5-399c-e063-6394a90a044a | 2026-03-10 | Warnings | M005 |
| Natouch Antifungal Wipes Plus | ANTIFUNGAL ANTISEPTIC WIPES PLUS | Natouch LLC | a85cb307-b3ad-1584-e053-2995a90a9a70 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb6fdfd-116e-14e9-e063-6294a90a4de3 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b | 2026-03-10 | Warnings | M005 |
| SootheSense Toenail Fungus Treatment | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ca2bbeb-3b8a-9482-e063-6294a90a5789 | 2026-03-09 | Warnings | M005 |
| Natouch Antifungal Antiseptic Wipes | ANTIFUNGAL ANTISEPTIC WIPES | Natouch LLC | 4c84c556-8d0b-ec28-e063-6294a90af1d3 | 2026-03-08 | Warnings | M005 |
| ANTIFUNGAL Cream | ANGELICA DAHURICA EXTRACTT, ASIATIC ACID | Guangzhou Mizi Biotechnology Co., LTD. | 4c586cd9-d356-34d8-e063-6294a90a4d11 | 2026-03-06 | Warnings | M005 |
| FungiFoam | TOLNAFTATE | The Tetra Corporation | 2449e8e5-9d7e-4119-9e7a-378efe55f875 | 2026-03-06 | Warnings | M005 |
| RoyceDerm ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4c43e62b-9060-8962-e063-6394a90aff63 | 2026-03-05 | Warnings | M005 |
| Derman Antifungal | TOLNAFTATE | Compania Internacional de Comercio, S.A.P.I. de C.V. | 5784a783-1056-4d50-8d87-2df4f8e16b09 | 2026-03-05 | Warnings | M005 |
| Antifungal Powder | TOLNAFTATE | ARMY & AIR FORCE EXCHANGE SERVICE | 4c39e121-4919-a482-e063-6294a90a98cd | 2026-03-04 | Warnings | M005 |
| ViLLsure Antifungal Pen | UNDECYLENIC ACID 25%ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c28cf04-94ad-8db6-e063-6394a90a2eed | 2026-03-03 | Warnings | M005 |
DailyMed RxNorm Mappings#
| 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 | 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 |