OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Calcium Carbonate 40%, Aminocaproic Acid 0.1%, Aluminum Chlorohydroxy Allantoinate 0.1%, Dibasic Calcium Phosphate 0.8%
Active Ingredients: Calcium Carbonate 40%, Aminocaproic Acid 0.1%, Aluminum Chlorohydroxy Allantoinate 0.1%, Dibasic Calcium Phosphate 0.8%
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, D-Sorbitol Solution, L-Menthol, Peppermint Oil, Medicinal Carbon
- Brush teeth twice daily or after each meal as directed by a dentist or doctor
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55526-0005-1 | 2019-12-27 | C162847 | 48780-1 | 9855d018-e9ae-cd31-e053-dbdaa90ab51a | 5da20eb3-0817-49e7-be6e-99b224b98b03 |
| 55526-0005-1 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e9ae-cd31-e053-dbdaa90ab51a | 5da20eb3-0817-49e7-be6e-99b224b98b03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AMINOCAPROIC ACID | ACTIVE INGREDIENT | U6F3787206 | 2 | |
| CALCIUM CARBONATE | ACTIVE INGREDIENT | H0G9379FGK | 2 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | ACTIVE INGREDIENT | O7TSZ97GEP | 2 | |
| AMINOCAPROIC ACID | ACTIVE MOIETY | U6F3787206 | 2 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ACTIVE MOIETY | L11K75P92J | 2 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 2 | |
| ERYTHRITOL | INACTIVE INGREDIENT | RA96B954X6 | 2 | |
| LEVOMENTHOL | INACTIVE INGREDIENT | BZ1R15MTK7 | 2 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55526-0005 | 55526-0005-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CALCIUM CARBONATE | H0G9379FGK | ACTIM |
| AMINOCAPROIC ACID | U6F3787206 | ACTIB |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | ACTIM |
| XYLITOL | VCQ006KQ1E | IACT |
| ERYTHRITOL | RA96B954X6 | IACT |
| SORBITOL | 506T60A25R | IACT |
| LEVOMENTHOL | BZ1R15MTK7 | IACT |
| PEPPERMINT OIL | AV092KU4JH | 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 |
|---|---|---|---|---|---|---|
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SYRUP / ORAL | 120 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SOLUTION / ORAL | 53 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | PASTE, DENTIFRICE / DENTAL | 49.3 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM / BUCCAL | 12 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SOLUTION / TOPICAL | 0.08 %w/v | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SOLUTION / ORAL | 15 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | POWDER / SUBLINGUAL | 1 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | GUM, CHEWING / BUCCAL | 113 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / ORAL | 526 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SOLUTION / DENTAL | 0.04 %v/v | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | LOTION / TOPICAL | 0.08 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CAPSULE / ORAL | 60 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE, DENTIFRICE / DENTAL | 14 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | ELIXIR / ORAL | 0.04 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION / ORAL | 1500 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SPRAY / TOPICAL | 2 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | SUSPENSION / ORAL | 1 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | POWDER, DENTIFRICE / DENTAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / SUBLINGUAL | 0.15 mg | ||
| LEVOMENTHOL | LEVOMENTHOL | BZ1R15MTK7 | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | LOZENGE / ORAL | 12 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 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 |
|---|---|---|---|---|---|---|
| fdda0bb7-0b08-430b-8296-82798661c361 | 5da20eb3-0817-49e7-be6e-99b224b98b03 | 2019-12-26 | Warnings | 5da20eb3-0817-49e7-be6e-99b224b98b03 |