BIS II Tooth
- Product NDC
- 69653-201
- 11-digit product format
- 696530201
- Labeler code
- 69653
- Product ID
- 69653-201_49f93562-4599-b3a9-e063-6294a90a813f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Jewoo Medical CO.,LTD
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-01-01
- Substance
- .ALPHA.-TOCOPHEROL ACETATE; ALCLOXA; CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- Active strength
- .04; .04; .1; .04 g/100g; g/100g; g/100g; g/100g
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BIS II Tooth
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| .ALPHA.-TOCOPHEROL ACETATE | .04 g/100g |
| ALCLOXA | .04 g/100g |
| CALCIUM CARBONATE | .1 g/100g |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | .04 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9E8X80D2L0, 18B8O9DQA2, H0G9379FGK, O7TSZ97GEP |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69653-201-01 | BIS II Tooth | 100 g in 1 TUBE | PASTE, DENTIFRICE | 100 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69653-201-01 | 69653020101 | 100 g in 1 TUBE (69653-201-01) | 100 g | 2026-01-01 | No | No | Historical |