Sodium fluoride
- Product NDC
- 65517-2000
- Requested package NDC
- 65517-2000-2
- 11-digit product format
- 655172000
- Labeler code
- 65517
- Product ID
- 65517-2000_736662e7-6fe5-24d4-e053-2991aa0ac9ba
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Toothpaste
- Dosage form
- CREAM
- Route
- ORAL
- Labeler
- DUKAL CORPORATION
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2013-11-13
- Marketing end
- 0000-00-00
- Substance
- SODIUM FLUORIDE
- Active strength
- 0 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 65517-2000 | 65517-2000-2 | D | Discontinued by firm | 2026-10-02 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65517-2000-0 | Sodium fluoride | 17 g in 1 TUBE | CREAM | 17 | 6 | |
| 65517-2000-1 | Sodium fluoride | 24 g in 1 TUBE | CREAM | 24 | 6 | |
| 65517-2000-2 | Sodium fluoride | 42 g in 1 TUBE | CREAM | 42 | 6 | |
| 65517-2000-3 | Sodium fluoride | 78 g in 1 TUBE | CREAM | 78 | 6 | |
| 65517-2000-4 | Sodium fluoride | 1 in 1 BOX | CREAM | 1 | 6 | |
| 65517-2000-4 | Sodium fluoride | 42 g in 1 TUBE | CREAM | 42 | 6 | |
| 65517-2000-5 | Sodium fluoride | 78 g in 1 TUBE | CREAM | 78 | 6 | |
| 65517-2000-5 | Sodium fluoride | 1 in 1 BOX | CREAM | 1 | 6 | |
| 65517-2000-6 | Sodium fluoride | 135 g in 1 TUBE | CREAM | 135 | 6 | |
| 65517-2000-6 | Sodium fluoride | 1 in 1 BOX | CREAM | 1 | 6 | |
| 65517-2000-7 | Sodium fluoride | 181 g in 1 TUBE | CREAM | 181 | 6 | |
| 65517-2000-7 | Sodium fluoride | 1 in 1 BOX | CREAM | 1 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65517-2000 | SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL LLC] | 6 | Legacy NDC, 12 package rows | 20240709_460c0f54-367a-4300-b066-5071d718ea73.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245598 | sodium fluoride 0.22 % Toothpaste | PSN | 460c0f54-367a-4300-b066-5071d718ea73 | 6 |
| 245598 | sodium fluoride 0.0022 MG/MG Toothpaste | SCD | 460c0f54-367a-4300-b066-5071d718ea73 | 6 |
| 245598 | sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste | SY | 460c0f54-367a-4300-b066-5071d718ea73 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65517-2000-2 | 65517200002 | 42 g in 1 TUBE (65517-2000-2) | 42 g | 2015-02-19 | 0000-00-00 | No | No | Current |