RoyceDerm CoolDefense Refreshing Shower Gel
- Product NDC
- 85424-007
- 11-digit product format
- 854240007
- Labeler code
- 85424
- Product ID
- 85424-007_3b3216d6-8cc9-ea89-e063-6294a90ab691
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tolnaftate 1.0%
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- RoyceDerm LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-31
- Substance
- TOLNAFTATE
- Active strength
- 1 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
- RoyceDerm CoolDefense Refreshing Shower Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLNAFTATE | 1 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 06KB629TKV |
| Rxcui | 2689792 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85424-007-01 | RoyceDerm CoolDefense Refreshing Shower Gel | 250 mL in 1 BOTTLE, PUMP | LIQUID | 250 | | 1 |
| 85424-007-01 | RoyceDerm CoolDefense Refreshing Shower Gel | 2 in 1 CARTON | LIQUID | 2 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85424-007-01 | 85424000701 | 2 BOTTLE, PUMP in 1 CARTON (85424-007-01) / 250 mL in 1 BOTTLE, PUMP | 2025-08-31 | No | No | Historical |