RoyceDerm Tinea Antifungal Cream
- Product NDC
- 85424-011
- 11-digit product format
- 854240011
- Labeler code
- 85424
- Product ID
- 85424-011_51214ad2-0c70-a6d2-e063-6394a90a9649
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate 2%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- RoyceDerm LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-07
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RoyceDerm Tinea Antifungal Cream
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE NITRATE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
| Rxcui | 998483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85424-011-01 | RoyceDerm Tinea Antifungal Cream | 57 g in 1 TUBE | CREAM | 57 | | 2 |
| 85424-011-02 | RoyceDerm Tinea Antifungal Cream | 57 g in 1 CARTON | CREAM | 57 | | 2 |
| 85424-011-01 | RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | 57 g in 1 TUBE | CREAM | 1 g in 57 | 20 mg in 1g | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85424-011-01 | 85424001101 | 57 g in 1 TUBE (85424-011-01) | 57 g | 2025-10-07 | No | No | Historical |
| 85424-011-02 | 85424001102 | 57 g in 1 CARTON (85424-011-02) | 57 g | 2026-05-27 | No | No | Historical |