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 Premium Plus Deep Clean Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b851fe5c-d904-12da-e053-2a95a90a86f9 | 2026-01-08 | Warnings | M021 |
| Crest Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | adebbd47-011d-4cd3-a002-1eb67e885e5b | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Stain Shield | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c9b5ef-8dd4-a842-e053-2a95a90ad387 | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Rush | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 7baa77f5-fe45-6566-e053-2991aa0a381f | 2026-01-08 | Warnings | M021 |
| Crest 3D White Vibrant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f63c3354-a264-8130-e053-2a95a90a2022 | 2026-01-08 | M021 | |
| Crest Pro Health Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb466fb4-0915-a41f-e053-6294a90a2dfb | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Clean and Free | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb4771cd-f478-e2bd-e053-6394a90aa83e | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Sensitive and Enamel Shield | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb48b15c-f821-e5cd-e053-6294a90ac64c | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Luminous Purple | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fbfcd837-4d88-5f82-e053-6394a90afbf6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health with a Touch of Scope | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb572b41-36cd-55d7-e053-6394a90a71c8 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Whitening Gel | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb5b1e94-bed6-8486-e053-6294a90a3a84 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Ultra Vivid Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | cba96ef0-0519-059f-e053-2a95a90a43ad | 2026-01-08 | Warnings | M021 |
| Crest 4in1 | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ce545406-3c4f-1ba7-e053-2a95a90a91ac | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d218ddc0-1d5f-f39b-e053-2995a90a96ed | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Antibacterial Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d58bc842-2687-e52d-e053-2995a90a5433 | 2026-01-08 | Warnings | M021 |
| Scope Stay Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d65b3153-2026-a8c0-e053-2a95a90a31d6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Charcoal | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6f68485-b92f-41c7-e053-2995a90a4fe5 | 2026-01-08 | Warnings | M021 |
| KIDS Crest Advanced Enamel Plus Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d837ecde-249a-7868-e053-2a95a90a56ae | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Intensive Cleaning | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6fa4187-a651-647b-e053-2995a90a8567 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Gum Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7729dde-c828-34e6-e053-2a95a90a5ee6 | 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 |