Supersmile
- Product NDC
- 53567-0972
- 11-digit product format
- 535670972
- Labeler code
- 53567
- Product ID
- 53567-0972_86a74ac3-795a-35d8-e053-2991aa0ab3d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Monofluorophosphate
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL; ORAL
- Labeler
- Robell Research, Inc.
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2014-07-14
- Marketing end
- 0000-00-00
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SODIUM MONOFLUOROPHOSPHATE | ACTIVE INGREDIENT | C810JCZ56Q | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| CALCIUM PEROXIDE | INACTIVE INGREDIENT | 7FRO2ENO91 | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| MAGNESIUM CARBONATE | INACTIVE INGREDIENT | 0E53J927NA | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| SODIUM LAURYL SULFOACETATE | INACTIVE INGREDIENT | D0Y70F2B9J | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| SODIUM PERBORATE | INACTIVE INGREDIENT | Y52BK1W96C | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 4 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53567-0972-3 | 53567097203 | 1 TUBE in 1 BOX (53567-0972-3) > 119 g in 1 TUBE | 1 tube | 2014-07-14 | 0000-00-00 | No | No | Current |
| 53567-0972-4 | 53567097204 | 14.2 g in 1 TUBE (53567-0972-4) | 14.2 g | 2014-07-14 | 0000-00-00 | No | No | Current |
| 53567-0972-8 | 53567097208 | 40 g in 1 TUBE (53567-0972-8) | 40 g | 2014-07-14 | 0000-00-00 | No | No | Current |