Opalescence Whitening Original Cool Mint
- Product NDC
- 51206-450
- 11-digit product format
- 512060450
- Labeler code
- 51206
- Product ID
- 51206-450_5d5bae70-3fe3-9953-e063-6394a90abdf9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Ultradent Products, Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-13
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.1 mg/g
- 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
- Opalescence Whitening Original Cool Mint
- Brand name suffix
- Cool Mint
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 1.1 mg/g |
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 |
|---|---|---|---|---|---|---|
| United Airlines Therabody Polaris Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | ab667740-55ab-470e-9514-163961502ceb | 2023-10-26 | Warnings | M021 |
| Cavity Protection Fresh Mint | SODIUM FLUORIDE | Oxyfresh Worldwide Inc | 0ae98f28-7e78-4379-93b0-4f2657415c4d | 2023-10-25 | Warnings | M021 |
| Tanners Tasty Vanilla Bling | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 521fe01e-7f2e-4d79-9126-e4880cdf4e71 | 2023-10-24 | Warnings | M021 |
| Tanners Tasty Ooh La La Orange | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 6027b961-314e-4f71-8b2f-646ce80214d8 | 2023-10-24 | Warnings | M021 |
| Tanners Tasty Cha Cha Chocolate | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 8609dbf3-7620-4a13-b40b-6bd705a78fb0 | 2023-10-24 | Warnings | M021 |
| Glister Multi-Action | SODIUM FLUORIDE | Access Business Group LLC | e3f2c049-a0f5-4649-a4aa-11bdb252f951 | 2023-10-23 | Warnings | M021 |
| UNITED Asutra TC Kit Colgate | SODIUM MONOFLUOROPHOSPHATE | MING FAI ENTERPRISE (CAMBODIA) CO., LTD | 082a581a-c7e5-e614-e063-6394a90a87da | 2023-10-20 | Warnings | M021 |
| Plak Smacker Anti Cavity Fluoride | SODIUM FLUORIDE | YOUNG PS ACQUISITION, LLC | c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe | 2023-10-16 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 152d84ee-d981-4032-bfb1-a559afe71d40 | 2023-10-11 | Warnings | M021 |
| Sodium Fluoride | SODIUM FLUORIDE | Safco Dental Supply LLC | 788080b3-fff8-4049-af98-f571824994c2 | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 5c312b36-07f4-406e-b3d3-c6d1e964635d | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 042636cf-8b61-4022-b0a1-af09c06b145b | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | f4c3569b-7b6a-4566-9e87-492f291c5165 | 2023-10-11 | Warnings | M021 |
| UNITED Asutra TC Kit Colgate | SODIUM MONOFLUOROPHOSPHATE | Procurall Solutions | 042817f9-675f-056a-e063-6394a90a2d97 | 2023-08-30 | Warnings | M021 |
| Colgate Max Fresh Cool Mint | SODIUM FLUORIDE | Mission Hills S.A de C.V | d142e43f-415a-41c5-a7db-8b18a039a323 | 2019-04-09 | Warnings | M021 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51206-450-01 | 51206045001 | 1 TUBE in 1 CARTON (51206-450-01) / 133 g in 1 TUBE | 1 tube | 2026-05-13 | No | No | Current |
| 51206-450-02 | 51206045002 | 12 CARTON in 1 PACKAGE, COMBINATION (51206-450-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE | 12 carton | 2026-05-13 | No | No | Current |
| 51206-450-03 | 51206045003 | 1 TUBE in 1 CARTON (51206-450-03) / 28 g in 1 TUBE | 1 tube | 2026-05-13 | No | No | Current |
| 51206-450-04 | 51206045004 | 24 CARTON in 1 PACKAGE, COMBINATION (51206-450-04) / 1 CARTON in 1 CARTON / 28 g in 1 CARTON | 24 carton | 2026-05-13 | No | No | Current |
| 51206-450-05 | 51206045005 | 48 CARTON in 1 PACKAGE, COMBINATION (51206-450-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE | 48 carton | 2026-05-13 | No | No | Current |