Orajel Sensitivity Relief
- Product NDC
- 10237-678
- 11-digit product format
- 102370678
- Labeler code
- 10237
- Product ID
- 10237-678_88d71cb7-8abf-407d-a74c-f5537497759a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride and Potassium Nitrate
- Dosage form
- PASTE, DENTIFRICE
- Route
- ORAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-31
- 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 Sensitivity Relief
- 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 |
|---|---|
| 7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-678-12 | Orajel Sensitivity Relief | 2 in 1 CARTON | PASTE, DENTIFRICE | 2 | 2 | |
| 10237-678-12 | Orajel Sensitivity Relief | 170 g in 1 TUBE | PASTE, DENTIFRICE | 170 | 2 | |
| 10237-678-43 | Orajel Sensitivity Relief | 121.9 g in 1 TUBE | PASTE, DENTIFRICE | 121.9 | 2 |
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 |
|---|---|---|---|---|---|---|
| Murchison Hume Dental Kit | SODIUM MONOFLUOROPHOSPHATE | Buzz Products Inc. | b1a442e1-86cf-cba6-e053-2995a90a593a | 2023-12-20 | Warnings | M021 |
| United Airlines Polaris Kit with Colgate | SODIUM MONOFLUOROPHOSPHATE | Buzz Export Services Pty Ltd (Buzz Products) | de4564a4-1012-baad-e053-2a95a90a11b7 | 2023-12-20 | Warnings | M021 |
| Orajel Complete Protection | SODIUM FLUORIDE | Church & Dwight Co., Inc. | daebd16f-d278-446d-8b7a-33add5a74fdd | 2023-12-19 | Warnings | M021 |
| Orajel Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | Church & Dwight Co., Inc. | 7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb | 2023-12-19 | Warnings | M021 10237-678 |
| ORTHO GUARD | SODIUM FLUORIDE | Massco Dental A Division of Dunagin Pharmaceuticals | 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd | 2023-12-17 | Warnings | M021 |
| Beyond Activated Coconut Charcoal and Sea Salt | SODIUM FLUORIDE | Beyond International Inc | d075fa15-7309-0c10-e053-2995a90a7c95 | 2023-11-28 | Warnings | M021 |
| Pro-Den Rx | STANNOUS FLUORIDE | Den-mat Holdings, Llc | 9036aa8a-59b1-41b0-b3cb-529d3303a1c0 | 2023-11-20 | Warnings | M021 |
| Fluoridex | STANNOUS FLUORIDE RINSE | DEN-MAT HOLDINGS, LLC | 5e81f073-c0ca-aa38-e053-2a91aa0ab37b | 2023-11-20 | Warnings | M021 |
| Hello Vitamin C Whitening | SODIUM FLUORIDE | Colgate-Palmolive Company | 38a0276e-910c-527d-1736-65928b9d4ca4 | 2023-11-20 | Warnings | M021 |
| POP Feeling Peachy | SODIUM FLUORIDE | LG H&H CO., LTD. | 0abaf99b-9547-46ae-e063-6394a90a6c15 | 2023-11-17 | Warnings | M021 |
| UNIVERSAL ANTI-CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | e3356374-befa-41b0-ab0f-edfd5a062601 | 2023-11-16 | Warnings | M021 |
| ANTI CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 421fc2f0-b118-4e7a-a399-ba4780028c54 | 2023-11-16 | Warnings | M021 |
| UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE | SODIUM FLUORIDE | Universal Distribution Center LLC | 3411924d-1002-460c-83e8-c0c7fbff9ad1 | 2023-11-16 | Warnings | M021 |
| ADVANCED WHITENING ANTI CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e | 2023-11-16 | Warnings | M021 |
| UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 879dfaf0-27c8-41a3-8d01-a1c3eec9edfc | 2023-11-15 | Warnings | M021 |
| EUTHYMOL Extraordinary Pink Whitening | SODIUM FLUORIDE | LG H&H CO., LTD. | 0989936c-237d-dc63-e063-6294a90a885f | 2023-11-07 | Warnings | M021 |
| Eurofresh Whitening | SODIUM FLUORIDE | Farmasi US LLC | b56b2b55-e3a4-785a-e053-2a95a90a7abf | 2023-11-05 | Warnings | M021 |
| Farmasi Whitening | SODIUM FLUORIDE | Farmasi US LLC | 25b3608e-abed-41ca-9971-21981b8a4610 | 2023-11-05 | Warnings | M021 |
| United Airlines Therabody UPP Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | fb6c355b-a67d-c4b4-e053-6394a90a0e66 | 2023-10-26 | Warnings | M021 |
| United Dental Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | 7f348fe7-9918-4934-bed0-f0a77c09d046 | 2023-10-26 | Warnings | M021 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10237-678-12 | 10237067812 | 2 TUBE in 1 CARTON (10237-678-12) / 170 g in 1 TUBE | 2 tube | 2024-06-01 | No | No | Current |
| 10237-678-43 | 10237067843 | 121.9 g in 1 TUBE (10237-678-43) | 121.9 g | 2024-01-31 | No | No | Current |