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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Antifungal Pen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UNDECYLENIC ACID | 25 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K3D86KJ24N |
| Rxcui | 998329 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85210-001 | ANTIFUNGAL PEN (UNDECYLENIC ACID 25%) LIQUID [XF AGENCIJA LIMITED] | 1 | Current NDC, 6 package rows | 20250129_a15d4512-0fc6-424f-9dd3-ab433d9b7a26.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |