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 |
|---|---|---|---|---|---|---|
| Crest Pro-Health Gum Rescue Pro Soothing Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 2f10c7ac-eb60-011e-e063-6394a90aca13 | 2026-01-08 | Warnings | M021 |
| Crest Deep Cleanse Cavity Defense | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 2e09cb3b-cf59-15b1-e063-6394a90a5c6a | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Maximum Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 2eaeddc5-1559-9378-e063-6394a90a4ed7 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Deep Stain Remover Dazzling Mint | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | 2f11e935-1711-5f1a-e063-6294a90af7d8 | 2026-01-08 | M021 | |
| HEB Gleaming White Fresh Mint | SODIUM FLUORIDE | HEB | 82491c8f-d2c2-2e4a-e053-2a91aa0a572f | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Pro Ultra White | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | 338acdf2-548c-0614-e063-6294a90af635 | 2026-01-08 | M021 | |
| KIDS Crest Advanced Sugar and Bacteria Shield | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 2f371af0-a2d4-25a6-e063-6394a90a923d | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Gum Detoxify Plus | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 2f9e346e-d664-81d5-e063-6394a90a4525 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Holiday Smile Deep Stain Remover and Whitestrips | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | 3c57d487-a3c7-b238-e063-6294a90aed81 | 2026-01-08 | M021 | |
| Crest Complete plus Scope Pro Advanced Freshness | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 325c3ab2-aaa2-a06f-e063-6294a90abefb | 2026-01-08 | Warnings | M021 |
| Crest Tartar Protection | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 5940711d-71b7-cb7d-e053-2a91aa0aef18 | 2026-01-08 | Warnings | M021 |
| Meijer Restore and Defend Sensitive | STANNOUS FLUORIDE | Meijer Distribution Inc | 82bdfdb5-39f2-8c09-e053-2991aa0a096c | 2026-01-08 | Warnings | M021 |
| Crest Strawberry | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f69824-e886-6e7b-e063-6294a90acf77 | 2026-01-08 | Warnings | M021 |
| Crest Bubblegum | SODIUM FLUORIDE | Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V. | 01f64874-6363-3dcc-e063-6394a90a2aec | 2026-01-08 | Warnings | M021 |
| Crest 3D White Fresh Mint | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f27a63-15f3-cee4-e063-6394a90afa3b | 2026-01-08 | Warnings | M021 |
| Crest Bubblegum | SODIUM FLUORIDE | Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V. | 01f618d7-be07-18c3-e063-6294a90a2d97 | 2026-01-08 | Warnings | M021 |
| Crest Strawberry | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f35279-76ce-6027-e063-6294a90a8e34 | 2026-01-08 | Warnings | M021 |
| Crest Snowberry | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 42ca1f06-3e7d-8fed-e063-6394a90afbff | 2026-01-08 | Warnings | M021 |
| Crest Strawberry | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 7d615c52-f9c9-4856-e053-2991aa0a7927 | 2026-01-08 | Warnings | M021 |
| Crest Fresh and White | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 5a1bb1fb-12a5-5fd1-e053-2991aa0a628b | 2026-01-08 | Warnings | 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 |