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 |
|---|---|---|---|---|---|---|
| Crest Pro Health Breath Purify and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c60fdacf-d997-19a5-e053-2a95a90a96a3 | 2026-01-08 | Warnings | M021 |
| Crest Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 3d7fffb9-47e0-73cd-e054-00144ff88e88 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Gum Detoxify Ultra | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c73ed36a-0e2f-a137-e053-2a95a90a43e0 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Extra Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c688d37e-9e80-4599-e053-2a95a90a1916 | 2026-01-08 | Warnings | M021 |
| Crest Gum Detoxify plus Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 63779942-0f6c-11c5-e053-2991aa0a25ab | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Sensitivity Active Foam | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | b8535d1c-cf15-f353-e053-2a95a90a7974 | 2026-01-08 | Warnings | M021 |
| Burts Bees Extra White Zen Peppermint | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 81279e1f-6224-8114-e053-2991aa0aab08 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Bacteria Shield and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c74229c4-b095-df32-e053-2a95a90a4aec | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Advanced Whitening Fresh Mint | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | c8350ab3-9347-58c0-e053-2995a90a7238 | 2026-01-08 | M021 | |
| Crest Premium Plus Anti-Bacterial | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | b7af946e-1cac-b8c0-e053-2a95a90afa4a | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Polishing Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ddcb0871-9900-125f-e053-2a95a90a75de | 2026-01-08 | M021 | |
| Burts Bees Deep Clean plus Whitening | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c924b8dd-8d84-1329-e053-2995a90a4531 | 2026-01-08 | Warnings | M021 |
| Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 07ed767e-225c-e9c5-e063-6394a90af931 | 2026-01-08 | Warnings | M021 |
| Crest Plus Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 0813171e-bda5-b004-e063-6394a90ad364 | 2026-01-08 | Warnings | M021 |
| Burts Bees Kids Strawberry Splash | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 087b3434-2636-74ce-e063-6394a90a25ad | 2026-01-08 | Warnings | M021 |
| Crest plus Tartar Protection Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 08776dfc-b07a-3729-e063-6394a90aeeed | 2026-01-08 | Warnings | M021 |
| Crest Plus Active Fresh plus Whitening Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 17f3b749-01ea-2561-e063-6294a90a5d3b | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Deep Clean | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | 128613c4-c06b-bdf5-e063-6294a90acd34 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Pro Rinse | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 13a01190-a6f3-17b3-e063-6294a90a36c2 | 2026-01-08 | Warnings | M021 |
| HEB HEBuddy | FLUORIDE | HEB | 2c972c65-34aa-4348-b997-c5e65a884575 | 2026-01-08 | 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 |