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- Product NDC
- 51009-916
- Requested package NDC
- 51009-916-51
- 11-digit product format
- 510090916
- Labeler code
- 51009
- Product ID
- 51009-916_ebd85879-2244-4f40-85b7-d951815ba22b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Monofluorophosphate
- Dosage form
- CREAM
- Route
- DENTAL
- Labeler
- Tom's of Maine, Inc.
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-06-30
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 51009-916 | 51009-916-51 | D | Discontinued by firm | 2026-10-12 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51009-916-51 | 51009091651 | 144 g in 1 TUBE (51009-916-51) | 144 g | 2021-06-30 | 0000-00-00 | No | No | Current |