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 fluoride rinse | SODIUM FLUORIDE | Topco Associates LLC | c3f2e952-a8d5-4e9d-a5c6-09e4f2544179 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Topco Associates LLC | a9b8b2fe-0a60-4f65-b6f6-aae8509c919f | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Salivea | FLUORIDE TOOTHPASTE | Laclede, Inc. | 4abb0f80-d87d-730f-e063-6294a90a15f7 | 2026-02-13 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Your Military Exchanges | 581d5cdb-018a-42ad-899d-5331f0063376 | 2026-02-12 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Your Military Exchanges | 965911c3-7aa8-4830-8269-6aa5d526ee73 | 2026-02-12 | Warnings, Adverse reactions | M021 |
| Mouth Rinse | SODIUM FLUORIDE | Walgreen Co. | eae87899-3eba-4d50-bc31-9eaf54ff9e00 | 2026-02-12 | Warnings, Adverse reactions | M021 |
| Crest Complete plus Whitening plus Scope Outlast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 960e0e3e-10e8-7426-e053-2a95a90a5b02 | 2026-02-12 | Warnings | M021 |
| Crest Fresh and White | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e | 2026-02-12 | Warnings | M021 |
| Kids Crest Cavity Protection Sparkle Fun | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 126c6f39-0ef7-40ee-b3ba-e56a76739c57 | 2026-02-12 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | CVS Pharmacy, Inc. | b2f7490c-e2af-49df-b054-70fb4815f729 | 2026-02-11 | Warnings, Adverse reactions | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | FORMIA LIMITED | b7d7c41e-f8b6-4e55-8acd-78eb6dda47c5 | 2026-02-09 | Warnings | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | FORMIA LIMITED | 48ef2635-7157-4cd7-9f99-967f0143f7f1 | 2026-02-09 | Warnings | M021 |
| Made by Dentists For Kids Eyeball Juice (Watermelon) | SODIUM FLUORIDE | MADE BY DENTISTS INC | 287887df-64de-4b5d-80e2-146c77c0fa8b | 2026-02-09 | Warnings | M021 |
| PERIOSCIENCES White Care AO Pro | SODIUM FLUORIDE | PERIOSCIENCES LLC | 092bdfa3-6267-439e-9320-e51b4805d1a1 | 2026-02-09 | Warnings | M021 |
| PERIOSCIENCES HYDRATING AO Pro | SODIUM MONOFLUOROPHOSPHATE | PERIOSCIENCES LLC | 5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3 | 2026-02-09 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Retail Business Services, LLC | 77c066cf-f064-45d3-9732-4433165ba9ef | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Retail Business Services, LLC | d1c878a9-2151-4986-be09-cbab658cdd31 | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Retail Business Services, LLC | 542e067a-c134-44c9-b962-f2a2b667b76f | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Colgate 5g Toothbrush Kit | SODIUM MONOFLUOROPHOSPHATE | Wuhan Jinshengyuan Textiles Manufacturing Co., Ltd. | 4f0fda5e-ef42-42c3-8270-3ba614650ad1 | 2026-02-06 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Retail Business Services, LLC | 3954edfd-f7f1-4218-9ee2-23f5b3661b4e | 2026-02-06 | 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 |