Twyneo
- Product NDC
- 51862-771
- 11-digit product format
- 518620771
- Labeler code
- 51862
- Product ID
- 51862-771_8557c350-45c9-48f8-8e1c-cc7569b3e7b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzoyl Peroxide and Tretinoin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mayne Pharma Commercial LLC
- Application
- NDA214902
- Marketing category
- NDA
- Marketing start
- 2025-08-01
- Substance
- BENZOYL PEROXIDE; TRETINOIN
- Active strength
- 30; 1 mg/g; mg/g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Twyneo
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOYL PEROXIDE | 30 mg/g |
| TRETINOIN | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W9WZN9A0GM, 5688UTC01R |
| Rxcui | 2565807, 2565812 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51862-771-30 | Twyneo | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 51862-771-30 | Twyneo | 30 g in 1 BOTTLE, PUMP | CREAM | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51862-771-30 | 51862077130 | 1 BOTTLE, PUMP in 1 CARTON (51862-771-30) / 30 g in 1 BOTTLE, PUMP | 2025-08-01 | No | No | Historical |