TheraBreath
- Product NDC
- 10237-273
- 11-digit product format
- 102370273
- Labeler code
- 10237
- Product ID
- 10237-273_59906b37-9bbf-710d-e063-6294a90abee4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Potassium nitrate, Sodium fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-15
- Substance
- SODIUM FLUORIDE; POTASSIUM NITRATE
- Active strength
- .24; 5 g/100g; g/100g
- 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
- TheraBreath
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .24 g/100g |
| POTASSIUM NITRATE | 5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
| RU45X2JN0Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1038929 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4b812a38-f7cb-51c8-e063-6394a90ab82c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-273-04 | TheraBreath | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 1 | |
| 10237-273-04 | TheraBreath | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 1 | |
| 10237-273-24 | TheraBreath | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 1 | |
| 10237-273-24 | TheraBreath | 2 in 1 CARTON | PASTE, DENTIFRICE | 2 | 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 |
|---|---|---|---|---|---|---|
| Crest Densify Daily Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d811306f-4994-7a5a-e053-2995a90adf16 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d810d4e5-ba66-efe1-e053-2995a90abfc0 | 2026-01-08 | Warnings | M021 |
| Crest Braces Care Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d823cba4-c4cf-7d7a-e053-2995a90a01f0 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Sensitive Relief | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7730674-7513-52cf-e053-2995a90ab32c | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Flavor | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 26a7a892-5da4-4749-bbb6-566efab7d749 | 2026-01-08 | Warnings | M021 |
| Crest Complete Multi-Benefit Plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8c91095d-88c0-4d22-a79a-7d0f0d05302b | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Deep Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d774295f-8ebd-9877-e053-2a95a90a9a0e | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Enamel Restore | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d813f5f0-3135-4a8f-e053-2a95a90a5562 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8e189fbd-5094-4398-b96c-8f95d89b9cdd | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Densify Rinse | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d84fb9f9-f2bc-358a-e053-2995a90abf07 | 2026-01-08 | Warnings | M021 |
| Kids Crest Strawberry Rush | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | eb7a5698-754c-4e46-e053-2a95a90a57b4 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Daily Cleansing and Whitening System | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 89a6fb36-5109-47f1-95ad-9381471ceeef | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced w/Extra Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 2c1c5563-0b7e-4c7c-b49f-3d72e078cd28 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Fresh Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c81ba39d-c7ea-b2a5-e053-2995a90a0fe7 | 2026-01-08 | M021 | |
| Crest Premium Plus Breath Bacteria Blast | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c3f1d477-6dd8-0ac4-e053-2a95a90a3742 | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Active Foam Whitening scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c72b15e0-e69c-65fc-e053-2a95a90a54c8 | 2026-01-08 | Warnings | M021 |
| Crest Complete Plus Scope Outlast Ultra | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c3f63455-b09e-9877-e053-2a95a90a1844 | 2026-01-08 | Warnings | M021 |
| Crest Tartar Protection Fresh Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 3d81d605-4f9b-3bb5-e054-00144ff88e88 | 2026-01-08 | Warnings | M021 |
| Crest Complete plus Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | e3b1f139-4fe8-f005-e053-2995a90a53b4 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Radiant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f3dd7a34-a0d8-4ac6-bbd1-7c3b86187a57 | 2026-01-08 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 1 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 1 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 1 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 1 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 1 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 1 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-273-04 | 10237027304 | 1 TUBE in 1 CARTON (10237-273-04) / 113 g in 1 TUBE | 1 tube | 2026-01-15 | No | No | Current |
| 10237-273-07 | 10237027307 | 1 TUBE in 1 CARTON (10237-273-07) / 19 g in 1 TUBE | 1 tube | 2026-08-21 | No | No | Current |
| 10237-273-24 | 10237027324 | 2 TUBE in 1 CARTON (10237-273-24) / 113 g in 1 TUBE | 2 tube | 2026-01-15 | No | No | Current |