SmartMouth
- Product NDC
- 76357-106
- 11-digit product format
- 763570106
- Labeler code
- 76357
- Product ID
- 76357-106_3edc9654-62e0-4c93-8cc7-123cd9edd10c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Monofluorophosphate
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Triumph Pharmaceuticals Inc.
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-06-17
- Marketing end
- 0000-00-00
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76357-106-04 | SmartMouth Advance Clinical Formula | 170 g in 1 TUBE | PASTE, DENTIFRICE | 170 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Sodium Monofluorophosphate | ACTIVE INGREDIENT | C810JCZ56Q | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Fluoride Ion | ACTIVE MOIETY | Q80VPU408O | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Benzoic Acid | INACTIVE INGREDIENT | 8SKN0B0MIM | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Hydrated Silica | INACTIVE INGREDIENT | Y6O7T4G8P9 | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
| Zinc Chloride | INACTIVE INGREDIENT | 86Q357L16B | SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76357-106 | SMARTMOUTH ADVANCE CLINICAL FORMULA (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] | 9 | Legacy NDC, 1 package rows | 20250101_9caa17c9-f864-4c9c-b2ea-dfaed0c6708e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76357-106-04 | 76357010604 | 170 g in 1 TUBE (76357-106-04) | 170 g | 2011-06-17 | 0000-00-00 | No | No | Current |