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 |
|---|---|---|---|---|---|---|
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Walmart Inc. | 1fd2f3ca-066e-282a-e063-6294a90a05a9 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | af5b93e7-5cce-4e01-8df2-54494d8b2910 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | 4590ca97-130c-46b2-9ba0-38f4703ef30a | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | MING FAI ENTERPRISE (CAMBODIA) CO., LTD. | 4ba81636-cdb7-e904-e063-6394a90a8bd5 | 2026-02-25 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Family Dollar Stores, Inc | 32a92add-c9db-4733-8e35-613825fdf081 | 2026-02-24 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Family Dollar Stores, Inc | 32ebc633-5338-4d5a-b075-f10b24761248 | 2026-02-24 | Warnings, Adverse reactions | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | H E B | 51ddc81b-1c90-4998-b538-6761ac113437 | 2026-02-24 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Meijer, Inc. | 9a0b6301-2443-41f7-adeb-87578a65c26d | 2026-02-24 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | CVS Pharmacy, Inc. | 344c9d00-ad82-46a9-83e9-68197e1a68bb | 2026-02-23 | Warnings, Adverse reactions | M021 |
| TheraBreath Complete Oral Rinse | ANTICAVITY ORAL RINSE | Church & Dwight Co., Inc. | 27c33ae1-52c7-baad-e063-6394a90a0611 | 2026-02-23 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Meijer, Inc. | 001777fb-196c-499a-94c8-6cdcef0958e9 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Meijer, Inc. | c628d02f-c834-42b3-b38d-6b9cdcdd0961 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Meijer, Inc. | b17f7a5d-272e-446d-803b-46a6d8e5f18f | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Meijer, Inc. | d85ce60c-ebff-461f-827a-10fddb9c2bf3 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| White Glo Charcoal Baking Soda Maximum White Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 580c4622-6f9c-48ea-b01e-6ffba7273f24 | 2026-02-19 | Warnings | M021 |
| White Glo Coffee and Tea Stain Remover Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | f044e213-2403-4f42-a41d-72d58fefcfcb | 2026-02-19 | Warnings | M021 |
| White Glo Mouthwash Protect Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 4691584f-8c0c-4589-8b40-89b1779a438d | 2026-02-19 | Warnings | M021 |
| White Glo Professional Choice Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | ed8d7506-0385-4422-be77-bcc2db79882f | 2026-02-19 | Warnings | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Meijer, Inc. | c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea | 2026-02-19 | 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 |