Stance
- Product NDC
- 57511-0201
- 11-digit product format
- 575110201
- Labeler code
- 57511
- Product ID
- 57511-0201_4cc1428e-fdc7-a943-e063-6394a90af86b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- 0.63% Stannous Fluoride Concentrate Rinse
- Dosage form
- RINSE
- Route
- TOPICAL
- Labeler
- Elevate Oral Care
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-08-25
- Substance
- STANNOUS FLUORIDE
- Active strength
- 1.2 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Stance
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | 1.2 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 583459 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ae71258-a8c2-6eb5-e054-00144ff88e88 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57511-0201-1 | Stance | 225 mL in 1 BOTTLE, PUMP | RINSE | 225 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57511-0201 | STANCE (0.63% STANNOUS FLUORIDE CONCENTRATE RINSE) RINSE [ELEVATE ORAL CARE] | 11 | Current NDC, Legacy NDC, 1 package rows | 20231031_3ae71258-a8c2-6eb5-e054-00144ff88e88.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CloSYS | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | ed617c7a-805c-4788-9bce-9b7fead4312d | 2026-03-31 | Warnings | M021 |
| Colgate Total Enamel Strength | STANNOUS FLUORIDE | Colgate-Palmolive Company | 1f29c893-e7c5-4a0e-941b-c2634d821147 | 2026-03-25 | Warnings | M021 |
| AP-24 Whitening | SODIUM MONOFLUOROPHOSPHATE | NSE Products, Inc. | 57e9e68c-41dd-470b-80db-dfaedc0e2a0a | 2026-03-24 | Warnings | M021 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369c0d44-6375-dcae-e063-6394a90a74d0 | 2026-03-24 | Warnings | M021 |
| Euthymol Whitening Purple Corrector | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369bc785-fb77-a56d-e063-6394a90a2e6b | 2026-03-24 | Warnings | M021 |
| SensitiveToothpaste | ANTI SENSITIVETOOTHPASTE | Huain Best Trade Co., Ltd. | 4db239f3-2ad7-3a5b-e063-6294a90a11a7 | 2026-03-23 | Warnings | M021 |
| Crest Bubblegum | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 7d6268c7-b273-1bbf-e053-2a91aa0a5d32 | 2026-03-17 | Warnings | M021 |
| Natures Promise Childrens Fluoride Strawberry | SODIUM MONOFLUOROPHOSPHATE | Foodhold U.S.A. | 81a4e196-8b2d-0745-e053-2991aa0a7de6 | 2026-03-16 | Warnings | M021 |
| Stance | 0.63% STANNOUS FLUORIDE CONCENTRATE RINSE | Elevate Oral Care | 3ae8badf-f960-62fd-e054-00144ff8d46c | 2026-03-11 | Warnings | M021 |
| Stance | 0.63% STANNOUS FLUORIDE CONCENTRATE RINSE | Elevate Oral Care | 3ae71258-a8c2-6eb5-e054-00144ff88e88 | 2026-03-11 | Warnings | M021 57511-0201 |
| Delta Travel Kit Comfort plus | SODIUM MONOFLUOROPHOSPHATE | Buzz Products Inc. | d31e0920-4317-1e0c-e053-2a95a90aebeb | 2026-03-11 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | CVS Pharmacy, Inc. | eac346d9-d9c1-4417-8193-390c7a0dcc2a | 2026-03-10 | Warnings, Adverse reactions | M021 |
| Crest Cavity Protection Regular | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 6caf3f2e-70a2-4530-99fa-f5af7e4c511a | 2026-03-10 | Warnings | M021 |
| Amerfresh Toothpowder | SODIUM FLUORIDE | Yangzhou ONE & ONLY Personal Care Products Co., LTD | 1cacf93e-aa60-4717-87ab-0568a701a4f3 | 2026-03-10 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | CVS Pharmacy, Inc. | a51357df-6d55-4030-a5db-42da7ba54a37 | 2026-03-09 | Warnings, Adverse reactions | M021 |
| Fluoride | FLUORIDE TOOTHPASTE | McKesson | 4c482e45-0502-a93a-e063-6394a90aa961 | 2026-03-05 | Warnings | M021 |
| Colgate Maximum Cavity Protection Bubble Fruit Flavor | SODIUM FLUORIDE | Colgate-Palmolive Company | 0a1389f6-cac9-3d58-0744-c488abb0bbcc | 2026-03-03 | Warnings | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Amazon.com Services LLC | 349eca80-2e0c-409b-af29-3235fdc0695b | 2026-03-03 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | Amazon.com Services LLC | 03735abc-d1be-4ca0-a497-0a5c5f289402 | 2026-03-03 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | f8036e2e-7541-4922-92b9-0d8319f7b64c | 2026-03-02 | Warnings, Adverse reactions | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 583459 | stannous fluoride 0.63 % Dental Solution | PSN | 3ae71258-a8c2-6eb5-e054-00144ff88e88 | 13 |
| 583459 | stannous fluoride 6.3 MG/ML Mouthwash | SCD | 3ae71258-a8c2-6eb5-e054-00144ff88e88 | 13 |
| 583459 | stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution | SY | 3ae71258-a8c2-6eb5-e054-00144ff88e88 | 13 |
| 583459 | stannous fluoride 0.63 % Dental Solution | SY | 3ae71258-a8c2-6eb5-e054-00144ff88e88 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57511-0201-1 | 57511020101 | 225 mL in 1 BOTTLE, PUMP (57511-0201-1) | 225 ml | 2016-08-25 | 0000-00-00 | No | No | Current |