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 |
|---|---|---|---|---|---|---|
| Colgate Cavity Protection Great Regular Flavor | ANTICAVITY FLUORIDE TOOTHPASTE | Colgate-Palmolive Company | 202c6c62-e16a-4716-babe-d5414006c79e | 2026-01-21 | Warnings | M021 |
| Crest 3D White Luxe Diamond Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c1420129-5460-4900-ac9a-356d2d7c60a2 | 2026-01-21 | Warnings | M021 |
| Crest Pro-Health Advanced Max Cavity and Erosion Prevention | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 48eb0bdc-7399-745d-e063-6294a90a9809 | 2026-01-21 | Warnings | M021 |
| Colgate Total Gum Protect Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | dcf81dcb-b26b-4411-82d4-5f7e9d3fc0f3 | 2026-01-20 | Warnings | M021 |
| GuruNanda Anti-Cavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3b07b72f-4efc-eb0f-e063-6294a90a70a8 | 2026-01-19 | Warnings | M021 |
| GuruNanda Anticavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3e90d516-3172-3c8d-e063-6294a90a394f | 2026-01-19 | Warnings | M021 |
| Hismile | PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0eba92d1-cbdc-9c96-e063-6294a90a9afc | 2026-01-15 | Warnings | M021 |
| Hismile | COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3cfb6-6bae-1682-e063-6394a90aca88 | 2026-01-15 | Warnings | M021 |
| Hismile | MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3f4f8-fdc4-2056-e063-6394a90a6fd7 | 2026-01-15 | Warnings | M021 |
| Hismile | SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef41051-dfa0-b105-e063-6294a90a551f | 2026-01-15 | Warnings | M021 |
| Hismile | WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef43107-58ec-d4ee-e063-6294a90ad8d7 | 2026-01-15 | Warnings | M021 |
| Hismile | RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef56539-dc21-c6ea-e063-6394a90a5790 | 2026-01-15 | Warnings | M021 |
| Hismile | GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef6f8b5-8565-b364-e063-6294a90aabbc | 2026-01-15 | Warnings | M021 |
| Hismile | STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef766ae-754a-f185-e063-6294a90a3299 | 2026-01-15 | Warnings | M021 |
| Hismile | BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef7be5b-df8f-9f32-e063-6394a90a4724 | 2026-01-15 | Warnings | M021 |
| Hismile | VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef8d0ef-a051-f610-e063-6394a90a8537 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d40b98b-2e9a-d84a-e063-6294a90a2096 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d44863e-93be-2b80-e063-6294a90a4a9d | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d458ccc-8f1e-f9c8-e063-6294a90a8da4 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d447939-fbf6-42f6-e063-6294a90af6d9 | 2026-01-15 | Warnings | 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 |