TheraBreath
- Product NDC
- 10237-268
- 11-digit product format
- 102370268
- Labeler code
- 10237
- Product ID
- 10237-268_4618e390-903a-a1d0-e063-6294a90ab294
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-02-03
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- TheraBreath
- Brand name suffix
- AM-PM Twin Pack
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 240698 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4618e390-9039-a1d0-e063-6294a90ab294 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-268-01 | TheraBreathAM-PM Twin Pack | 1 in 1 CARTON | KIT | 1 | 1 |
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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | PSN | 4618e390-9039-a1d0-e063-6294a90ab294 | 1 |
| 240698 | sodium fluoride 0.5 MG/ML Mouthwash | SCD | 4618e390-9039-a1d0-e063-6294a90ab294 | 1 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | SY | 4618e390-9039-a1d0-e063-6294a90ab294 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-268-01 | 10237026801 | 1 KIT in 1 CARTON (10237-268-01) * 473 mL in 1 BOTTLE, PLASTIC * 473 mL in 1 BOTTLE, PLASTIC | 1 kit | 2025-02-03 | No | No | Current |