TheraBreath Healthy Gums
- Product NDC
- 10237-258
- 11-digit product format
- 102370258
- Labeler code
- 10237
- Product ID
- 10237-258_3d3505a3-77e1-1402-e063-6294a90ad2a3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETYLPYRIDINIUM CHLORIDE
- Dosage form
- RINSE
- Route
- ORAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-02-13
- Substance
- CETYLPYRIDINIUM CHLORIDE
- Active strength
- .01 mg/20mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TheraBreath Healthy Gums
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETYLPYRIDINIUM CHLORIDE | .01 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D9OM4SK49P |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10237-258-01 | TheraBreath Healthy Gums | 1000 mL in 1 BOTTLE, PLASTIC | RINSE | 1000 | | 8 |
| 10237-258-03 | TheraBreath Healthy Gums | 88.7 mL in 1 BOTTLE, PLASTIC | RINSE | 88.7 | | 8 |
| 10237-258-10 | TheraBreath Healthy Gums | 296 mL in 1 BOTTLE, PLASTIC | RINSE | 296 | | 8 |
| 10237-258-16 | TheraBreath Healthy Gums | 473 mL in 1 BOTTLE, PLASTIC | RINSE | 473 | | 8 |
| 10237-258-21 | TheraBreath Healthy Gums | 2 in 1 PACKAGE | RINSE | 2 | | 8 |
| 10237-258-21 | TheraBreath Healthy Gums | 1000 mL in 1 BOTTLE, PLASTIC | RINSE | 1000 | | 8 |
| 10237-258-26 | TheraBreath Healthy Gums | 2 in 1 BOX | RINSE | 2 | | 8 |
| 10237-258-26 | TheraBreath Healthy Gums | 473 mL in 1 BOTTLE, PLASTIC | RINSE | 473 | | 8 |
| 10237-258-16 | TheraBreath | 473 mL in 1 BOTTLE, PLASTIC | RINSE | 473 mL | 0.01 mg in 20mL | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10237-258 | THERABREATH HEALTHY GUMS (CETYLPYRIDINIUM CHLORIDE) RINSE [CHURCH & DWIGHT CO., INC.] | 7 | Current NDC, 8 package rows | 20250223_e06bfc9e-38e5-475b-89c1-026ccfe56031.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 10237-258-01 | 10237025801 | 1000 mL in 1 BOTTLE, PLASTIC (10237-258-01) | 1000 ml | 2023-02-13 | No | No | Current |
| 10237-258-03 | 10237025803 | 88.7 mL in 1 BOTTLE, PLASTIC (10237-258-03) | 88.7 ml | 2023-02-13 | No | No | Current |
| 10237-258-10 | 10237025810 | 296 mL in 1 BOTTLE, PLASTIC (10237-258-10) | 296 ml | 2025-12-23 | No | No | Current |
| 10237-258-16 | 10237025816 | 473 mL in 1 BOTTLE, PLASTIC (10237-258-16) | 473 ml | 2023-02-13 | No | No | Current |
| 10237-258-21 | 10237025821 | 2 BOTTLE, PLASTIC in 1 PACKAGE (10237-258-21) / 1000 mL in 1 BOTTLE, PLASTIC | | 2025-03-31 | No | No | Current |
| 10237-258-26 | 10237025826 | 2 BOTTLE, PLASTIC in 1 BOX (10237-258-26) / 473 mL in 1 BOTTLE, PLASTIC | | 2024-02-01 | No | No | Current |