OTC - ACTIVE INGREDIENT SECTION
silicon dioxide
silicon dioxide
r-aminocapric acid, aluminium chloro hydroxy allantoinate, zeolite, polyedhylene glycol 1500, d-sorbitol solution, glycerine, erythritol, steviol giucoside, xylitol, licorice extract, lactic acid bacteria, sodium carboxymethyl cellulose, methyl parahydroxy benzoate, hydroxylapatite, sodium lauryl sulfate, coolmint flavor, mint flavor, l-menthol, dl-menthol, dionized water
for dental care
keep out or reach of the children
apply 1 to 3 times with desired amount of product onto teeth per day
do not swallow
for dental use only
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61165-1001-1 | 2019-12-26 | C162847 | 48780-1 | 9855e2a2-3936-60a7-e053-dbdaa90a05bd | Drug Facts |
| 61165-1001-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3936-60a7-e053-dbdaa90a05bd | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SILICON DIOXIDE | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SILICON DIOXIDE | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61165-1001 | 61165-1001-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
| XYLITOL | VCQ006KQ1E | IACT |
| MENTHOL | L7T10EIP3A | 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 |
|---|---|---|---|---|---|---|
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / SUBLINGUAL | 2 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOAP / TOPICAL | 0.75 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | DROPS / OPHTHALMIC | NA | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION / ORAL | 1500 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | JELLY / NASAL | 32.5 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SUSPENSION / ORAL | 1 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CREAM / TOPICAL | 0.1 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | MOUTHWASH / BUCCAL | 0.15 mg/1ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | GUM, CHEWING / BUCCAL | 89 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | LOTION / TOPICAL | 0.05 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | PASTE, DENTIFRICE / DENTAL | 4.7 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | INHALANT / NASAL | 32 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CAPSULE / ORAL | 0.87 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION, CONCENTRATE / ORAL | 0.5 mg/1ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / DENTAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / ORAL | 0.58 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | DROPS / NASAL | 40.32 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET, ORALLY DISINTEGRATING / ORAL | 14 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | GEL / TOPICAL | 0.1 %w/w |
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 |
|---|---|---|---|---|---|---|
| e31d3296-05ed-48e1-bb0c-7d7fad66efac | 3fb552ae-2077-4656-9799-279822716db3 | 2019-12-26 | Warnings | 3fb552ae-2077-4656-9799-279822716db3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.