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 |
|---|---|---|---|---|---|---|
| Eversmile TheraFoam | 0.05% SODIUM FLUORIDE RINSE | Everbrands, Inc. | 57da2479-923a-45ec-8149-57b469b11637 | 2026-04-13 | Warnings | M021 |
| Crest Pro-Health Advanced Bacteria Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ce508-fe6e-4045-e063-6294a90ab3e2 | 2026-04-10 | Warnings | M021 |
| Crest Pro-Health Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 4f1d62ae-653e-3046-e063-6294a90abbf8 | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Peppermint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ef07b-ee68-e6ae-e063-6394a90af5e5 | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f20343e-6c03-48e8-e063-6294a90a8cdf | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Smooth Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f2042b4-8eae-5c2c-e063-6394a90a640c | 2026-04-10 | Warnings | M021 |
| Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4146d-6281-fe66-e063-6394a90a32c3 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef5261e-9d2f-ae05-e063-6294a90a489a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f0876d9-41c9-d891-e063-6394a90a1cbd | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Charcoal with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef57a05-b9f5-42f7-e063-6294a90a5d89 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint with Stain Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ee26a82-16fd-f0fb-e063-6394a90a91d1 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Whitening Therapy Deep Clean Charcoal | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | 812c1519-1a4b-2495-e053-2a91aa0a914a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4e7c2-1f58-59fc-e063-6294a90ad43b | 2026-04-08 | Warnings | M021 |
| Anticavity mouth rinse Low-foaming Spearmint | 779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT | Dyson Technology Limited | 4ef669b9-defe-8965-e063-6394a90ab335 | 2026-04-08 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c89efc-5fa0-2a05-e053-2a95a90a7b9c | 2026-04-07 | Warnings | M021 |
| Crest 3D White Advanced Charcoal | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f4eb8111-53da-17ae-e053-2a95a90a1127 | 2026-04-07 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | 35385ada-bd8d-4d38-9587-0256885f749f | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | cf0c8b48-0d1c-406a-a67d-7d16187d38d8 | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Crest 3D White Arctic Fresh | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fa08a877-b9e5-4eba-b832-3a28f4f3f83c | 2026-04-07 | Warnings | M021 |
| Anticavity Fluoride | SODIUM FLUORIDE | Family Dollar (FAMILY WELLNESS) | 63c4c0e9-84b1-4076-bdf4-7e9543b2cf46 | 2026-04-01 | 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 |