Cool sense Care Plus
- Product NDC
- 76670-0013
- 11-digit product format
- 766700013
- Labeler code
- 76670
- Product ID
- 76670-0013_2c472d51-102b-14ef-e063-6394a90a02fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium fluoride
- Dosage form
- MOUTHWASH
- Route
- DENTAL
- Labeler
- DOCSMEDI Co., Ltd.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-12-01
- Substance
- SODIUM FLUORIDE
- Active strength
- .05 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 76670-0013-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 76670-0013-1 | 0efc9e666f02… | f202fb6c5f17… |
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
- Cool sense Care Plus
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .05 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 240698 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ea18ac56-4ef1-4bf0-8c26-6885183fd684 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76670-0013-1 | Cool sense Care Plus | 250 mL in 1 BOTTLE | MOUTHWASH | 250 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76670-0013 | COOL SENSE CARE PLUS (SODIUM FLUORIDE) MOUTHWASH [DOCSMEDI CO., LTD.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250123_ea18ac56-4ef1-4bf0-8c26-6885183fd684.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 |
|---|---|---|---|---|---|---|
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | PSN | ea18ac56-4ef1-4bf0-8c26-6885183fd684 | 5 |
| 240698 | sodium fluoride 0.5 MG/ML Mouthwash | SCD | ea18ac56-4ef1-4bf0-8c26-6885183fd684 | 5 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | SY | ea18ac56-4ef1-4bf0-8c26-6885183fd684 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76670-0013-1 | 76670001301 | 250 mL in 1 BOTTLE (76670-0013-1) | 250 ml | 2022-12-01 | 0000-00-00 | No | No | Current |