4-in-1 Teeth Care Pens
- Product NDC
- 83778-011
- 11-digit product format
- 837780011
- Labeler code
- 83778
- Product ID
- 83778-011_3f872924-0c45-267b-e063-6394a90a1a67
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- 4-in-1 Teeth Care Pens
- Dosage form
- GEL, DENTIFRICE
- Route
- TOPICAL
- Labeler
- Jiangxi Dentalbright Technology Co., Ltd
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-20
- Substance
- SODIUM FLUORIDE
- Active strength
- .25 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 4-in-1 Teeth Care Pens
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | .25 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83778-011-02 | 4-in-1 Teeth Care Pens | 2 g in 1 TUBE | GEL, DENTIFRICE | 2 | | 2 |
| 83778-011-01 | 4-in-1 Teeth Care Pens | 2 g in 1 TUBE | GEL, DENTIFRICE | 2 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83778-011-01 | 83778001101 | 2 g in 1 TUBE (83778-011-01) | 2 g | 2025-10-30 | No | No | Historical |
| 83778-011-02 | 83778001102 | 2 g in 1 TUBE (83778-011-02) | 2 g | 2025-10-30 | No | No | Historical |