Mycozyl AL
- Product NDC
- 59088-443
- 11-digit product format
- 590880443
- Labeler code
- 59088
- Product ID
- 59088-443_07edd043-4ac5-b2de-e063-6394a90af25d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tolnaftate
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- PURETEK CORPORATION
- Application
- M005
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2023-10-17
- Substance
- TOLNAFTATE
- Active strength
- .1 g/10mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mycozyl AL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLNAFTATE | .3 g/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 06KB629TKV |
| Rxcui | 313423 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59088-443-03 | Mycozyl AL | 30 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 30 | | 3 |
| 59088-443-03 | Miconatate | 30 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 1 mL in 30 | 0.3 g in 30mL | 3 |
| 59088-443-01 | Mycozyl AL | 10 mL in 1 BOTTLE | LIQUID | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59088-443 | MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION] | 3 | Current NDC, Legacy NDC | 20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip |
| 59088-443 | MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241004_b82c9a8a-f6f1-dca6-e053-2995a90a47f9.zip |
| 59088-443 | MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION] | 1 | Current NDC, Legacy NDC, 1 package rows | 20231018_07edd043-4ac4-b2de-e063-6394a90af25d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59088-443-01 | 59088044301 | 10 mL in 1 BOTTLE (59088-443-01) | 10 ml | 2023-10-17 | | No | No | Current |
| 59088-443-03 | 59088044303 | 30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) | 30 ml | 2021-06-09 | 0000-00-00 | No | No | Current |