SmileCare Mouth Ulcer Gel
- Product NDC
- 87512-004
- 11-digit product format
- 875120004
- Labeler code
- 87512
- Product ID
- 87512-004_4d6db039-5b98-8f3f-e063-6294a90a9d85
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Yantai Aien Biotechnology Co., Ltd.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-20
- Substance
- MENTHOL
- Active strength
- .1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SmileCare Mouth Ulcer Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | .1 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87512-004-01 | SmileCare Mouth Ulcer Gel | 10 g in 1 TUBE | GEL | 10 | | 1 |
| 87512-004-02 | SmileCare Mouth Ulcer Gel | 15 g in 1 TUBE | GEL | 15 | | 1 |
| 87512-004-03 | SmileCare Mouth Ulcer Gel | 20 g in 1 TUBE | GEL | 20 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87512-004-01 | 87512000401 | 10 g in 1 TUBE (87512-004-01) | 10 g | 2026-03-20 | No | No | Current |
| 87512-004-02 | 87512000402 | 15 g in 1 TUBE (87512-004-02) | 15 g | 2026-03-20 | No | No | Current |
| 87512-004-03 | 87512000403 | 20 g in 1 TUBE (87512-004-03) | 20 g | 2026-03-20 | No | No | Current |