Antifungal Pen
- Product NDC
- 85210-001
- 11-digit product format
- 852100001
- Labeler code
- 85210
- Product ID
- 85210-001_9e2dd8ab-e1b8-43fd-b156-f3788c591db4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- UNDECYLENIC ACID 25%
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- XF Agencija Limited
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-28
- 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
- Antifungal Pen
- 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 |
|---|---|
| a15d4512-0fc6-424f-9dd3-ab433d9b7a26 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85210-001-01 | Antifungal Pen | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 85210-001-01 | Antifungal Pen | 3 mL in 1 APPLICATOR | LIQUID | 3 | 1 | |
| 85210-001-02 | Antifungal Pen | 3 mL in 1 APPLICATOR | LIQUID | 3 | 1 | |
| 85210-001-02 | Antifungal Pen | 3 in 1 CARTON | LIQUID | 3 | 1 | |
| 85210-001-03 | Antifungal Pen | 6 in 1 CARTON | LIQUID | 6 | 1 | |
| 85210-001-03 | Antifungal Pen | 3 mL in 1 APPLICATOR | LIQUID | 3 | 1 |
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 |
|---|---|---|---|---|---|---|
| Oiangna Tea Tree Oil Antifungal | CLOTRIMAZOLE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 453452a7-c613-6111-e063-6294a90aca81 | 2025-12-05 | Warnings | M005 |
| Tinactin Antifungal | TOLNAFTATE | Bayer HealthCare LLC. | 5f95be36-6efa-4dfb-9a40-88f4ce1de2b3 | 2025-12-05 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | c3b715a9-233a-401a-ba60-f78c1ddf1ded | 2025-12-05 | Warnings | M005 |
| Lotrimin | CLOTRIMAZOLE | Bayer HealthCare LLC. | b584e17f-ed43-43bd-b643-dfa48edd78c6 | 2025-12-05 | Warnings | M005 |
| Fungicure Night Cream | CLOTRIMAZOLE | Kobayashi Healthcare International, Inc. | 43029403-2afd-cfa1-e063-6394a90a99a3 | 2025-12-04 | Warnings | M005 |
| Lotrimin Daily Prevention Deo | TOLNAFTATE | Bayer HealthCare LLC. | 9e8bfb78-ad81-93d0-e053-2995a90aa41d | 2025-12-04 | Warnings | M005 |
| Lotrimin AF Jock Itch | MICONAZOLE NITRATE | Bayer Healthcare LLC. | 0c53cf0f-767e-a422-e063-6394a90ab764 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | 0a80a5b0-3216-46f6-8801-7066ef59aee4 | 2025-12-04 | Warnings | M005 |
| Lotrimin Antifungal | CLOTRIMAZOLE | Bayer HealthCare LLC. | f9536683-3f32-4c71-9b6a-70f8611e3dcf | 2025-12-04 | Warnings | M005 |
| Lotrimin AF Deodorant | MICONAZOLE NITRATE | Bayer HealthCare LLC. | 0bee54eb-df2f-15fe-e063-6294a90a2fd2 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC. | 0beda157-efd2-5245-e063-6394a90a6911 | 2025-12-04 | Warnings | M005 |
| Lotrimin AF | MICONAZOLE NITRATE | Bayer Healthcare LLC. | 163996c6-af54-21ac-e063-6394a90ac05c | 2025-12-04 | Warnings | M005 |
| Lotrimin Daily Prevent Deodorant | TOLNAFTATE | Bayer HealthCare LLC. | 1bb961cd-b6e6-3aff-e063-6394a90a432e | 2025-12-04 | Warnings | M005 |
| Tinactin Deodorant | TOLNAFTATE | Bayer HealthCare LLC. | 1751d576-e94a-d7d1-e063-6294a90a03ff | 2025-12-04 | Warnings | M005 |
| Tinactin Jock Itch | TOLNAFTATE | Bayer HealthCare LLC | 163ab4df-6e4a-6239-e063-6294a90a1cd0 | 2025-12-04 | Warnings | M005 |
| Tinactin | TOLNAFTATE | Bayer HealthCare LLC | bb878f31-2189-4427-aacf-5bce96d75978 | 2025-12-04 | Warnings | M005 |
| Lotrimin | CLOTRIMAZOLE | Bayer HealthCare LLC | da948ef3-3709-4bfc-9d17-f6f1ea325343 | 2025-12-04 | Warnings | M005 |
| Myco Nail A Antifungal Solution | UNDECYLENIC ACID | Kramer Novis | 550358d7-69e8-4ea3-bcf9-d647c457287d | 2025-12-04 | Warnings | M005 |
| Tea Tree Oil Antifungal Soaps | TOLNAFTATE | Nanjing Jitaxing Technology Co., LTD | 4517d3a7-9144-b91d-e063-6294a90a4990 | 2025-12-03 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | A-S Medication Solutions | 23ca78c0-16a9-455c-99a7-b9a9a3affa60 | 2025-12-03 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998329 | undecylenic acid 25 % Topical Solution | PSN | a15d4512-0fc6-424f-9dd3-ab433d9b7a26 | 1 |
| 998329 | undecylenic acid 250 MG/ML Topical Solution | SCD | a15d4512-0fc6-424f-9dd3-ab433d9b7a26 | 1 |
| 998329 | undecylenic acid 25 % Topical Solution | SY | a15d4512-0fc6-424f-9dd3-ab433d9b7a26 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85210-001-01 | 85210000101 | 1 APPLICATOR in 1 CARTON (85210-001-01) / 3 mL in 1 APPLICATOR | 1 applicator | 2025-01-28 | No | No | Current |
| 85210-001-02 | 85210000102 | 3 APPLICATOR in 1 CARTON (85210-001-02) / 3 mL in 1 APPLICATOR | 3 applicator | 2025-01-28 | No | No | Current |
| 85210-001-03 | 85210000103 | 6 APPLICATOR in 1 CARTON (85210-001-03) / 3 mL in 1 APPLICATOR | 6 applicator | 2025-01-28 | No | No | Current |