NDC 10237-775
Orajel
Sodium Fluoride
Orajel is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Sodium Fluoride.
| Product ID | 10237-775_71713187-f51c-fcf1-e053-2995a90abe69 |
| NDC | 10237-775 |
| Product Type | Human Otc Drug |
| Proprietary Name | Orajel |
| Generic Name | Sodium Fluoride |
| Dosage Form | Gel, Dentifrice |
| Route of Administration | DENTAL |
| Marketing Start Date | 2018-07-20 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Labeler Name | Church & Dwight Co., Inc. |
| Substance Name | SODIUM FLUORIDE |
| Active Ingredient Strength | 6 mg/g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 10237-775-42
1 g in 1 TUBE (10237-775-42)
| Marketing Start Date | 2018-07-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 10237-775-42 [10237077542]
Orajel GEL, DENTIFRICE
| Marketing Category | OTC monograph final |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-07-20 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 6 mg/g |
OpenFDA Data
| SPL SET ID: | 71713187-f51b-fcf1-e053-2995a90abe69 |
| Manufacturer | |
| UNII |
NDC Crossover Matching brand name "Orajel" or generic name "Sodium Fluoride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 72337-776 | Orajel | Orajel |
| 10237-775 | Orajel | Orajel |
| 0135-0234 | AQUAFRESH | sodium fluoride |
| 0126-0021 | Colgate | SODIUM FLUORIDE |
| 0126-0034 | Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride | SODIUM FLUORIDE |
| 0126-0032 | Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride | SODIUM FLUORIDE |
| 0041-1421 | Oral-B | Sodium Fluoride |
| 0126-0131 | Phos-Flur | Sodium Fluoride |
| 0126-0135 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0138 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0139 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0074 | PrevidDent 5000 Booster Plus Spearmint | Sodium Fluoride |
| 0126-0016 | PreviDent | Sodium fluoride |
| 0126-0075 | PreviDent | Sodium fluoride |
| 0126-0076 | PreviDent | Sodium fluoride |
| 0126-0179 | PreviDent | Sodium Fluoride |
| 0126-0286 | PreviDent | Sodium Fluoride |
| 0126-0287 | PreviDent | Sodium Fluoride |
| 0126-0072 | PreviDent 5000 Booster Plus Fruitastic | Sodium Fluoride |
| 0126-0033 | PreviDent Alcohol Free | Sodium Fluoride |
| 0126-0088 | PreviDent Fresh Mint | Sodium Fluoride |
| 0126-0289 | PreviDent OrthoDefense | SODIUM FLUORIDE |
| 0126-0288 | PreviDent Very Berry | Sodium Fluoride |
Trademark Results [Orajel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORAJEL 88721637 not registered Live/Pending |
CHURCH & DWIGHT CO., INC. 2019-12-10 |
 ORAJEL 85639740 4277337 Dead/Cancelled |
Church & Dwight Co., Inc. 2012-05-31 |
 ORAJEL 85639732 4277336 Dead/Cancelled |
Church & Dwight Co., Inc. 2012-05-31 |
 ORAJEL 85135337 3950958 Live/Registered |
Church & Dwight Co., Inc. 2010-09-22 |
 ORAJEL 77653394 3647531 Live/Registered |
CHURCH & DWIGHT CO., INC. 2009-01-21 |
 ORAJEL 77648363 3647521 Live/Registered |
CHURCH & DWIGHT CO., INC. 2009-01-13 |
 ORAJEL 73277429 1166935 Live/Registered |
COMMERCE DRUG CO., INC. 1980-09-09 |
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