Orajel Complete Protection
- Product NDC
- 10237-677
- 11-digit product format
- 102370677
- Labeler code
- 10237
- Product ID
- 10237-677_1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-01
- Substance
- SODIUM FLUORIDE; POTASSIUM NITRATE
- Active strength
- .243; 5 g/100g; g/100g
- 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
- Orajel Complete Protection
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .243 g/100g |
| POTASSIUM NITRATE | 5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
| RU45X2JN0Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| daebd16f-d278-446d-8b7a-33add5a74fdd | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-677-12 | Orajel Complete Protection | 170 g in 1 TUBE | PASTE | 170 | 3 | |
| 10237-677-12 | Orajel Complete Protection | 2 in 1 CARTON | PASTE | 2 | 3 | |
| 10237-677-43 | Orajel Complete Protection | 121.9 g in 1 TUBE | PASTE | 121.9 | 3 | |
| 10237-677-43 | Orajel Complete Protection | 1 in 1 CARTON | PASTE | 1 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Oral Antivavity | SODIUM FLUORIDE | Meijer, Inc. | af34f83f-1328-4897-9d04-72ca5a4101bf | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Meijer, Inc. | acff939e-e98c-4d89-a0c4-0254dc74e672 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity fluoride rinse | SODIUM FLUORIDE | Meijer, Inc. | 0bb9fb5f-1893-4187-b60b-05319a8fac6a | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Listerine Total Care Intense Anticavity Fluoride Mouthwash | SODIUM FLUORIDE | Kenvue Brands LLC | 4b0404af-309f-7c31-e063-6294a90a5aa1 | 2026-02-18 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Target Corporation | abfc1973-60ab-44e5-8147-33739d8bd7a3 | 2026-02-18 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Target Corporation | 3e4119b2-9506-4305-8cff-163f700265d0 | 2026-02-18 | Warnings, Adverse reactions | M021 |
| Toms of Maine Whiten Plus Deep Clean Peppermint | SODIUM FLUORIDE | Tom's of Maine | 4c535776-3f80-4eeb-bb63-2d734c3c3a6b | 2026-02-18 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | dd6bf8df-1e28-4f61-b876-b9f1f8d5993a | 2026-02-17 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | 8283cea0-7b62-4796-8763-6654039664cd | 2026-02-17 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | 9d055fed-26d8-4827-a4cc-8c314514a6c3 | 2026-02-17 | Warnings | M021 |
| Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR | SODIUM FLUORIDE | Ashtel Studios, Inc. | 28d1b8c3-930f-4ac9-aa5a-b72b832bb77e | 2026-02-17 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Valu Merchandisers Company | 088b95e6-30fd-4263-9fdc-57cd63385b71 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Valu Merchandisers Company | e31c1609-a1c3-4ed5-adfd-3cfa63205ec3 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | 3602c528-5f53-4d41-bf67-163149f52b35 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | e696038c-182e-4325-9b90-87fe498d9f67 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Topco Associates LLC | 3b04142a-4a65-45ba-a5a2-e62b0c47ec55 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Mouth Rinse | SODIUM FLUORIDE | Topco Associates LLC | c640adc0-e178-4b6a-af44-07d2f7da81d3 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Topco Associates LLC | f760f8f8-0c74-4a6e-b5c9-cc82b8758a45 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Topco Associates LLC | ade7dcb2-b4e2-4cef-b9a7-469867ead68a | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | Topco Associates LLC | 84b30711-a7e5-4189-895a-a7989f05591c | 2026-02-13 | Warnings, Adverse reactions | M021 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-677-12 | 10237067712 | 2 TUBE in 1 CARTON (10237-677-12) / 170 g in 1 TUBE | 2 tube | 2024-05-01 | No | No | Current |
| 10237-677-43 | 10237067743 | 1 TUBE in 1 CARTON (10237-677-43) / 121.9 g in 1 TUBE | 1 tube | 2024-01-01 | No | No | Current |