Undecylenic Acid
- Product NDC
- 49283-025
- 11-digit product format
- 492830025
- Labeler code
- 49283
- Product ID
- 49283-025_0bc72bd8-1f30-b01c-e063-6394a90a77ea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Undecylenic Acid
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Chemco Corporation
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-08-16
- Substance
- UNDECYLENIC ACID
- Active strength
- 25 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Undecylenic Acid
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| UNDECYLENIC ACID | 25 g/100mL |
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 |
|---|---|
| 7391b53f-5567-1f45-e053-2991aa0a4fce | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49283-025-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-df49-f424-e053-dadaa90a57ce | 49283-025-05 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49283-025-05 | Undecylenic Acid | 15 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 15 | 4 |
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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH TOENAIIL RENEWAL PEN | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eea5ee7-0ef9-8d34-e063-6294a90af595 | 2026-04-07 | Warnings | M005 |
| EXTRA STRENGTH TOENAIIL RENEWAL Solution | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eeaa2f0-efc7-eab3-e063-6294a90a13b3 | 2026-04-07 | Warnings | M005 |
| Extra Strength Toenail Renewal Pen | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eeb59d2-3891-2e45-e063-6294a90a4fcf | 2026-04-07 | Warnings | M005 |
| RoyceDerm Tinea ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4e889f2b-9ea1-b1a6-e063-6394a90a4654 | 2026-04-03 | Warnings | M005 |
| Toenail Fungus Treatment Extra Strength Pen | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 28fbcc50-a3ac-d6d1-e063-6294a90aa2b6 | 2026-04-02 | Warnings | M005 |
| TOENAIL FUNGUS TREATMENT Liquid | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 28fc7049-e367-42bf-e063-6394a90a6f06 | 2026-04-02 | Warnings | M005 |
| Fungal Nail Patches | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 299a63ad-f321-117c-e063-6394a90a3a22 | 2026-04-02 | Warnings | M005 |
| Secura Antifungal Greaseless | MICONAZOLE NITRATE | Smith & Nephew Medical Ltd | 9be600e4-76ec-4071-a8ec-a0b23155271d | 2026-04-02 | Warnings | M005 |
| FifthPulse Bacitracin Zinc | BACITRACIN ZINC | WeCare Products LLC | 5c6b3ad8-c158-4cc0-b1ba-b829b5df1284 | 2026-04-02 | Warnings | M005 |
| FifthPulse Miconazole Nitrate Antifungal | MICONAZOLE NITRATE | WeCare Products LLC | b70238eb-afcb-4e09-976f-973df249241c | 2026-04-02 | Warnings | M005 |
| ANTIFUNGAL PEN | UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE | Hanyang Qisheng (Shenzhen) Technology Co., Ltd. | 4e85f338-ffd7-85b1-e063-6294a90a3c87 | 2026-04-02 | Warnings | M005 |
| RoyceDerm Anti-Fungal Cream | MICONAZOLE NITRATE 2% | RoyceDerm LLC | 4e861073-88e8-b2f7-e063-6394a90ab94a | 2026-04-02 | Warnings | M005 |
| Miconazole Nitrate | JOCK ITCH SPRAY | CVS Pharmacy | 7b70d3ea-126a-42aa-8509-b982893c710b | 2026-04-01 | Warnings | M005 |
| Fungicure Anti-Fungal Liquid | TOLNAFTATE | Kobayashi Healthcare International, Inc. | b18ee199-0659-733c-e053-2a95a90ab6b5 | 2026-04-01 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | CVS Pharmacy | 96cc594d-85c8-4f62-bc0a-3176c8739f21 | 2026-04-01 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | CVS Pharmacy | a7b6bd7c-23db-43e1-92f7-e27f5f4801de | 2026-04-01 | Warnings | M005 |
| Baza Antifungal | MICONAZOLE NITRATE | Coloplast Corp | 75182cb7-840a-423a-9c20-10840d6e1d65 | 2026-03-31 | Warnings | M005 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Trifecta Pharmaceuticals Usa Llc | 80217dbb-a0f0-414a-8d22-a9a346b017aa | 2026-03-31 | Warnings | M005 |
| RoyceDerm Antifungal Bar | CLOTRIMAZOLE | RoyceDerm LLC | 3abdc4a8-58dd-5bd0-e063-6294a90a1bca | 2026-03-31 | Warnings | M005 |
| Critic Aid Clear AF | MICONAZOLE NITRATE | Coloplast Corp | cbc5d976-850a-476e-b179-b7a5a8675524 | 2026-03-31 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998329 | undecylenic acid 25 % Topical Solution | PSN | 7391b53f-5567-1f45-e053-2991aa0a4fce | 4 |
| 998329 | undecylenic acid 250 MG/ML Topical Solution | SCD | 7391b53f-5567-1f45-e053-2991aa0a4fce | 4 |
| 998329 | undecylenic acid 25 % Topical Solution | SY | 7391b53f-5567-1f45-e053-2991aa0a4fce | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49283-025-05 | 49283002505 | 15 mL in 1 BOTTLE, WITH APPLICATOR (49283-025-05) | 15 ml | 2018-08-16 | No | No | Current |