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 |
|---|---|---|---|---|---|---|
| Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash | SODIUM FLUORIDE | Kenvue Brands LLC | 28986d7f-3e9a-8dfb-e063-6394a90a731e | 2025-12-10 | Warnings | M021 |
| Toms of Maine Tropical Island | ALUMINUM CHLOROHYDRATE | Colgate-Palmolive Company | 0d6c51bc-5391-4533-b4fd-961dc4f36342 | 2025-12-10 | Warnings | M021 |
| Business Class Kit | SODIUM MONOFLUOROPHOSPHATE | American Airlines, Inc. | 483d7aec-34ac-49c5-ac0e-8fba5b4737ae | 2025-12-09 | Warnings | M021 |
| Colgate Anticavity Kit | SODIUM MONOFLUOROPHOSPHATE | Ming Fai Industrial (Shenzhen) Co. Ltd | 121decce-c364-4060-87da-0c6a6cd48474 | 2025-12-08 | Warnings | M021 |
| First Class Kit | SODIUM MONOFLUOROPHOSPHATE | American Airlines, Inc. | ba717de8-c3a2-41bf-85a1-aa75f9744d30 | 2025-12-08 | Warnings | M021 |
| United Airlines Business Class Kit | SODIUM MONOFLUOROPHOSPHATE | United Airlines | 94c5e9a4-19f3-4590-9da4-313c75261231 | 2025-12-08 | Warnings | M021 |
| Dr. Jen SuperPaste Nano-Hydroxyapatite | SODIUM FLUORIDE | Dr Jen Natural, LLC | 5f08d994-e458-42b2-aa39-e84fca3acf48 | 2025-12-05 | Warnings | M021 |
| Colgate Anticavity Kit | SODIUM MONOFLUOROPHOSPHATE | Ming Fai Industrial (Shenzhen) Co. Ltd | 86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec | 2025-12-05 | Warnings | M021 |
| Dr. Jen SuperPaste Nano-Hydroxyapatite | SODIUM FLUORIDE | Dr Jen Natural, LLC | 8b28b857-9162-4065-b0a0-571efffe9787 | 2025-12-05 | Warnings | M021 |
| Dr. Jen SuperPaste Ortho | SODIUM FLUORIDE | Dr Jen Natural, LLC | 9dd248bf-9488-43cd-a041-e8315a05ce5d | 2025-12-04 | Warnings | M021 |
| Dr. Jen SuperPaste Perio | SODIUM FLUORIDE | Dr Jen Natural, LLC | 8c7e6d3a-49d9-4098-9d5e-e9792b373574 | 2025-12-04 | Warnings | M021 |
| Colgate Total Plaque Cleanse | STANNOUS FLUORIDE | Colgate-Palmolive Company | b2980238-5bcb-467f-9e90-a307938632c2 | 2025-12-03 | Warnings | M021 |
| Advance White Extreme Whitening Tartar Control | SODIUM FLUORIDE | Church & Dwight Co., Inc. | b539264f-e1ff-440b-af76-84266fe2c0a2 | 2025-12-02 | Warnings | M021 |
| Sensodyne Pronamel Clinical Enamel Strength Fresh Breath | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | 34a1a32e-3017-f018-e063-6394a90a0230 | 2025-12-01 | Warnings | M021 |
| Freshmint Anticavity Fluoride | SODIUM MONOFLUOROPHOSPHATE | New World Imports, Inc | 77e51d6f-c1a2-4650-b3dd-5e4552379e77 | 2025-12-01 | Warnings | M021 |
| Freshmint Sensitive | POTASSIUM NITRATE AND SODIUM FLUORIDE | New World Imports, Inc | aa2e0864-3325-4acf-a2c5-0eb27eb18baf | 2025-12-01 | Warnings | m021 |
| PRO-SYS | SODIUM FLUORIDE AND POTASSIUM NITRATE | Benco Dental | 4e470ba4-60bb-1815-e063-6294a90abacc | 2025-12-01 | Warnings | M021 |
| PRO-SYS | SODIUM FLUORIDE | Benco Dental | 4e539cb2-bcbd-95fc-e063-6294a90a2121 | 2025-12-01 | Warnings | M021 |
| Cool sense Care Plus | SODIUM FLUORIDE | DONG IL PHARMS CO., LTD. | 44763bf6-caf3-ec69-e063-6394a90a0ee1 | 2025-11-25 | Warnings | M021 |
| DOCTRUST DOUBLEX Tooth | SODIUM FLUORIDE | DONG IL PHARMS CO.,LTD | 44765e86-2eb2-6381-e063-6394a90a761f | 2025-11-25 | 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 |