RoyceDerm Tea Tree Therapeutic
- Product NDC
- 85424-012
- 11-digit product format
- 854240012
- Labeler code
- 85424
- Product ID
- 85424-012_46542754-2257-a23c-e063-6394a90a7795
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Salicylic Acid 3%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- RoyceDerm LLC
- Application
- M032
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-15
- Substance
- SALICYLIC ACID
- Active strength
- 3 mg/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RoyceDerm Tea Tree Therapeutic
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SALICYLIC ACID | 3 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O414PZ4LPZ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85424-012-01 | RoyceDerm Tea Tree Therapeutic | 350 mL in 1 CARTON | GEL | 350 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85424-012-01 | 85424001201 | 350 mL in 1 CARTON (85424-012-01) | 350 ml | 2025-12-15 | No | No | Historical |