Supersmile
- Product NDC
- 53567-0738
- 11-digit product format
- 535670738
- Labeler code
- 53567
- Product ID
- 53567-0738_e6fdf6a0-179b-a7ac-e053-2995a90a8236
- 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
- 2016-11-04
- 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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53567-0738-1 | 53567073801 | 198.4 g in 1 TUBE (53567-0738-1) | 198.4 g | 2016-11-04 | 0000-00-00 | No | No | Current |
| 53567-0738-2 | 53567073802 | 198.4 g in 1 BOTTLE, PUMP (53567-0738-2) | 198.4 g | 2017-11-13 | 0000-00-00 | No | No | Current |
| 53567-0738-3 | 53567073803 | 70.8 g in 1 TUBE (53567-0738-3) | 70.8 g | 2018-05-23 | 0000-00-00 | No | No | Current |
| 53567-0738-4 | 53567073804 | 1 TUBE in 1 BOX (53567-0738-4) > 6 g in 1 TUBE | 1 tube | 2018-08-07 | 0000-00-00 | Yes | No | Current |