Epsolay
- Product NDC
- 51862-772
- 11-digit product format
- 518620772
- Labeler code
- 51862
- Product ID
- 51862-772_a27367f0-2505-460d-98a1-20fe24f41657
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzoyl Peroxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mayne Pharma Commercial LLC
- Application
- NDA214510
- Marketing category
- NDA
- Marketing start
- 2025-08-01
- Substance
- BENZOYL PEROXIDE
- Active strength
- 30 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Epsolay
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOYL PEROXIDE | 30 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W9WZN9A0GM |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51862-772-30 | Epsolay | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 51862-772-30 | Epsolay | 30 g in 1 BOTTLE, PUMP | CREAM | 30 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51862-772-30 | 51862077230 | 1 BOTTLE, PUMP in 1 CARTON (51862-772-30) / 30 g in 1 BOTTLE, PUMP | 2025-08-01 | No | No | Current |