BenzoAzeline 10
- Product NDC
- 78863-1310
- 11-digit product format
- 788631310
- Labeler code
- 78863
- Product ID
- 78863-1310_256eec2c-7298-46d3-93bc-e7c41375fd8a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZOYL PEROXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Noon Aesthetics M.R. Ltd
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-01
- Substance
- BENZOYL PEROXIDE
- Active strength
- 1000 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BenzoAzeline 10
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOYL PEROXIDE | 1000 mg/mL |
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 |
|---|
| 78863-1310-1 | BenzoAzeline 10 | 50 mL in 1 TUBE | CREAM | 50 | | 2 |
| 78863-1310-1 | BenzoAzeline 10 | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 78863-1310-2 | BenzoAzeline 10 | 15 mL in 1 BOTTLE, PUMP | CREAM | 15 | | 2 |
| 78863-1310-2 | BenzoAzeline 10 | 1 in 1 CARTON | CREAM | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78863-1310 | BENZOAZELINE 10 (BENZOYL PEROXIDE) CREAM [NOON AESTHETICS M.R. LTD] | 1 | Current NDC, 4 package rows | 20240301_985efa19-bd91-45cd-a2a0-d71ec325e51c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 78863-1310-1 | 78863131001 | 1 TUBE in 1 CARTON (78863-1310-1) / 50 mL in 1 TUBE | 1 tube | 2024-03-01 | No | No | Historical |
| 78863-1310-2 | 78863131002 | 1 BOTTLE, PUMP in 1 CARTON (78863-1310-2) / 15 mL in 1 BOTTLE, PUMP | | 2024-03-01 | No | No | Historical |