ONEXTON
- Product NDC
- 0187-3050
- 11-digit product format
- 001873050
- Labeler code
- 0187
- Product ID
- 0187-3050_bcf2f805-f7d5-45b4-b352-a1e114e00e48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clindamycin Phosphate and Benzoyl Peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA050819
- Marketing category
- NDA
- Marketing start
- 2014-11-24
- Substance
- BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
- Active strength
- 37.5; 10 mg/g; mg/g
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONEXTON
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOYL PEROXIDE | 37.5 mg/g |
| CLINDAMYCIN PHOSPHATE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W9WZN9A0GM, EH6D7113I8 |
| Rxcui | 1598470, 1598826 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-3050-35 | ONEXTON | 3.5 g in 1 TUBE | GEL | 3.5 | | 20 |
| 0187-3050-50 | ONEXTON | 1 in 1 CARTON | GEL | 1 | | 20 |
| 0187-3050-50 | ONEXTON | 50 g in 1 BOTTLE, PUMP | GEL | 50 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-3050 | ONEXTON (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [BAUSCH HEALTH US, LLC] | 15 | Current NDC, Legacy NDC, 3 package rows | 20200519_697e760a-c206-4565-8f4e-a8085e215827.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-3050-35 | 00187305035 | 3.5 g in 1 TUBE (0187-3050-35) | 3.5 g | 2014-11-24 | 0000-00-00 | No | No | Current |
| 0187-3050-50 | 00187305050 | 1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMP | | 2014-11-24 | 0000-00-00 | No | No | Current |