Supersmile
- Product NDC
- 53567-0552
- 11-digit product format
- 535670552
- Labeler code
- 53567
- Product ID
- 53567-0552_e6fe1aee-a52a-e008-e053-2a95a90af202
- 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
- 2013-05-01
- Marketing end
- 0000-00-00
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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.] | 9 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| CALCIUM PEROXIDE | INACTIVE INGREDIENT | 7FRO2ENO91 | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| MAGNESIUM CARBONATE | INACTIVE INGREDIENT | 0E53J927NA | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| SODIUM LAURYL SULFOACETATE | INACTIVE INGREDIENT | D0Y70F2B9J | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| SODIUM PERBORATE | INACTIVE INGREDIENT | Y52BK1W96C | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.] | 9 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53567-0552-1 | 53567055201 | 1 TUBE in 1 BOX (53567-0552-1) > 40 g in 1 TUBE | 1 tube | 2013-05-01 | 0000-00-00 | Yes | No | Current |
| 53567-0552-2 | 53567055202 | 1 TUBE in 1 BOX (53567-0552-2) > 119 g in 1 TUBE | 1 tube | 2013-05-01 | 0000-00-00 | No | No | Current |
| 53567-0552-3 | 53567055203 | 6 g in 1 TUBE (53567-0552-3) | 6 g | 2013-05-01 | 0000-00-00 | No | No | Current |
| 53567-0552-4 | 53567055204 | 70.8 g in 1 TUBE (53567-0552-4) | 70.8 g | 2018-12-11 | 0000-00-00 | No | No | Current |
| 53567-0552-8 | 53567055208 | 227 g in 1 TUBE (53567-0552-8) | 227 g | 2018-03-06 | 0000-00-00 | No | No | Current |