Biocorneum
- Product NDC
- 84440-003
- 11-digit product format
- 844400003
- Labeler code
- 84440
- Product ID
- 84440-003_2996022f-311c-4161-b6cc-1c746e9151d9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Meradimate, Octisalate, and Octocrylene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Biodermis LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-01
- Substance
- AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30; 150; 50; 50; 100 mg/g; mg/g; mg/g; mg/g; 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
- Biocorneum
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/g |
| HOMOSALATE | 150 mg/g |
| MERADIMATE | 50 mg/g |
| OCTISALATE | 50 mg/g |
| OCTOCRYLENE | 100 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, J9QGD60OUZ, 4X49Y0596W, 5A68WGF6WM |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84440-003 | BIOCORNEUM (AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE) GEL [BIODERMIS LLC] | 1 | Current NDC, 6 package rows | 20240901_ef95f2b7-e438-4990-880d-81621edb2002.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84440-003-10 | 84440000310 | 1 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE | 1 tube | 2024-09-01 | No | No | Current |
| 84440-003-20 | 84440000320 | 1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE | 1 tube | 2024-09-01 | No | No | Current |
| 84440-003-50 | 84440000350 | 1 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE | 1 tube | 2024-09-01 | No | No | Current |