OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Calcium Phosphate Tribasic 19%, Colloidal Silicon Dioxide 2.5%
Active Ingredients: Calcium Phosphate Tribasic 19%, Colloidal Silicon Dioxide 2.5%
Purpose: Anticavity
Keep out of reach of children under 6 years old
- Supervise children as necessary until being capable of using without supervision
- Instruct children under 6 years old in good brushing and rinsing habits
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Inactive Ingredients: Xylitol, Erythritol, Chitosan, D-Sorbitol Solution, L-Menthol, Lactic Acid
- Brush teeth twice daily or after each meal as directed by a dentist or doctor
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55526-0004-1 | 2019-12-27 | C162847 | 48780-1 | 9855d018-d589-cd31-e053-dbdaa90ab51a | 1d955366-a435-4dca-828d-8af3cdcf3201 |
| 55526-0004-1 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d589-cd31-e053-dbdaa90ab51a | 1d955366-a435-4dca-828d-8af3cdcf3201 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SILICON DIOXIDE | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TRICALCIUM PHOSPHATE | ACTIVE INGREDIENT | K4C08XP666 | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| COLLOIDAL SILICON DIOXIDE | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| ERYTHRITOL | INACTIVE INGREDIENT | RA96B954X6 | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | 1 | |
| LEVOMENTHOL | INACTIVE INGREDIENT | BZ1R15MTK7 | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55526-0004 | 55526-0004-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TRICALCIUM PHOSPHATE | K4C08XP666 | ACTIR |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
| XYLITOL | VCQ006KQ1E | IACT |
| ERYTHRITOL | RA96B954X6 | IACT |
| SORBITOL | 506T60A25R | IACT |
| LEVOMENTHOL | BZ1R15MTK7 | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| XYLITOL | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE, DENTIFRICE / DENTAL | 14 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | CREAM / VAGINAL | 0.81 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | OINTMENT / TOPICAL | ADJ PH | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SOLUTION / TOPICAL | 0.08 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | TABLET / ORAL | ADJ PH | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | SUSPENSION / TOPICAL | 0.7 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / NASAL | 25 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | GEL / TOPICAL | 30 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | LOTION / TOPICAL | 0.08 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | CAPSULE / ORAL | 132 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | INJECTION / INTRACARDIAC | 0.01 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | TABLET / ORAL | 5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SPRAY / SUBLINGUAL | 0.05 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | CONCENTRATE / ORAL | 50 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SOLUTION / ORAL | 15 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | INJECTION / INTRAVENOUS | 2232 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SPRAY / TOPICAL | 2 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | LOTION / TOPICAL | 5.7 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SUSPENSION / ORAL | 1 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | GUM, CHEWING / BUCCAL | 113 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0f90eb38-194d-4266-840a-1fdcc0127814 | 1d955366-a435-4dca-828d-8af3cdcf3201 | 2019-12-26 | Warnings | 1d955366-a435-4dca-828d-8af3cdcf3201 |
Adverse event summaries are temporarily unavailable. Other product information remains available.