PanOxyl
- Product NDC
- 0316-0284
- 11-digit product format
- 003160284
- Labeler code
- 0316
- Product ID
- 0316-0284_3bdcb3d7-164d-e678-e063-6394a90a3d6b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- CROWN LABORATORIES
- Application
- ANDA215940
- Marketing category
- ANDA
- Marketing start
- 2025-08-08
- Substance
- ADAPALENE
- Active strength
- 1 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
- PanOxyl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
| Rxcui | 307731 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0316-0284-15 | PanOxyl | 15 g in 1 TUBE | GEL | 15 | | 1 |
| 0316-0284-15 | PanOxyl | 1 in 1 CARTON | GEL | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0316-0284-15 | 00316028415 | 1 TUBE in 1 CARTON (0316-0284-15) / 15 g in 1 TUBE | 1 tube | 2025-08-08 | No | No | Current |