OTC - ACTIVE INGREDIENT SECTION
sodium fluoride
sodium fluoride
menthol, DL-alanine, polydextrose, sodium benzoate, sodium saccharin, sodium acetate, citric acid flavor lemon, purified water
for dental care
keep out or reach of the children
rinse for 30 seconds with one pack of mouthwash morning and night
do not swallow
for dental use only
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61526-1001-1 | 2023-08-27 | C162847 | 48780-1 | 9855e2a2-3909-60a7-e053-dbdaa90a05bd | Drug Facts |
| 61526-1001-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3909-60a7-e053-dbdaa90a05bd | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 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 |
|---|---|
| 61526-1001 | 61526-1001-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| XYLITOL | VCQ006KQ1E | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
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 | SOLUTION / ORAL | 3 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | PASTE, DENTIFRICE / DENTAL | 4.7 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | JELLY / NASAL | 32.5 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CREAM / TOPICAL | 0.1 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION, CONCENTRATE / ORAL | 0.5 mg/1ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | INHALANT / NASAL | 32 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | GUM, CHEWING / BUCCAL | 89 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / ORAL | 0.58 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | DROPS / OPHTHALMIC | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SUSPENSION / ORAL | 1 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CAPSULE / ORAL | 0.87 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / SUBLINGUAL | 2 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / DENTAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | DROPS / NASAL | 40.32 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | LOTION / TOPICAL | 0.05 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION / ORAL | 1500 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOAP / TOPICAL | 0.75 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | MOUTHWASH / BUCCAL | 0.15 mg/1ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET, ORALLY DISINTEGRATING / ORAL | 14 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | GEL / TOPICAL | 0.1 %w/w | ||
| 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 |
|---|---|---|---|---|---|---|
| 03f10bd4-32f5-7923-e063-6294a90a88d3 | fcaa4ccd-7d80-492a-9aa1-54eedfb2307d | 2023-08-27 | Warnings | 03f10bd4-32f5-7923-e063-6294a90a88d3 fcaa4ccd-7d80-492a-9aa1-54eedfb2307d |
Adverse event summaries are temporarily unavailable. Other product information remains available.