Naftin
- Product NDC
- 83107-023
- 11-digit product format
- 831070023
- Labeler code
- 83107
- Product ID
- 83107-023_3b299c91-fdf6-726c-e063-6394a90ad77b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naftifine Hydrochloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Legacy Pharma USA Inc.
- Application
- NDA204286
- Marketing category
- NDA
- Marketing start
- 2025-07-29
- Substance
- NAFTIFINE HYDROCHLORIDE
- Active strength
- 2 g/100g
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naftin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAFTIFINE HYDROCHLORIDE | 2 g/100g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 25UR9N9041 |
| Rxcui | 1433734, 1433736 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8f630d5a-8a28-4ac5-8ede-8b54b7617055 | Product name | 3 | 20210512 |
| 6aca302d-6492-4ac9-8829-e023cb64c91c | Product name | 1 | 20190627 |
| ba2e3195-29b1-b94a-4345-149632e97b51 | Product name | 3 | 20161117 |
| 7ac69d99-c06d-0e83-7872-6229bc9878f9 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83107-023-45 | Naftin | 45 g in 1 TUBE | GEL | 45 | 1 | |
| 83107-023-45 | Naftin | 1 in 1 CARTON | GEL | 1 | 1 | |
| 83107-023-60 | Naftin | 1 in 1 CARTON | GEL | 1 | 1 | |
| 83107-023-60 | Naftin | 60 g in 1 TUBE | GEL | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83107-023-45 | GM - Gram | 83107-023 | 689226cc-fa46-4ca2-8484-bc5059029c29 | 1 | 2025-12-16 |
| 83107-023-60 | GM - Gram | 83107-023 | 3e9de213-02ac-4077-91b5-d2e1a784ca56 | 1 | 2025-12-16 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1433734 | naftifine HCl 2 % Topical Gel | PSN | 6c6ee055-4031-45a7-8561-ccd989343580 | 1 |
| 1433736 | NAFTIN 2 % Topical Gel | PSN | 6c6ee055-4031-45a7-8561-ccd989343580 | 1 |
| 1433736 | naftifine hydrochloride 0.02 MG/MG Topical Gel [Naftin] | SBD | 6c6ee055-4031-45a7-8561-ccd989343580 | 1 |
| 1433734 | naftifine hydrochloride 0.02 MG/MG Topical Gel | SCD | 6c6ee055-4031-45a7-8561-ccd989343580 | 1 |
| 1433734 | naftifine hydrochloride 2 % Topical Gel | SY | 6c6ee055-4031-45a7-8561-ccd989343580 | 1 |
| 1433736 | Naftin 0.02 MG/MG Topical Gel | SY | 6c6ee055-4031-45a7-8561-ccd989343580 | 1 |
| 1433736 | Naftin 2 % Topical Gel | SY | 6c6ee055-4031-45a7-8561-ccd989343580 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83107-023-45 | 83107002345 | 1 TUBE in 1 CARTON (83107-023-45) / 45 g in 1 TUBE | 1 tube | 2025-07-29 | No | No | Historical |
| 83107-023-60 | 83107002360 | 1 TUBE in 1 CARTON (83107-023-60) / 60 g in 1 TUBE | 1 tube | 2025-07-29 | No | No | Historical |