Orajel 4X Medicated For Toothache and Gum is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzocaine; Menthol; Benzalkonium Chloride; Zinc Chloride.
| Product ID | 10237-787_99d3357b-524f-53a7-e053-2a95a90a2c38 |
| NDC | 10237-787 |
| Product Type | Human Otc Drug |
| Proprietary Name | Orajel 4X Medicated For Toothache and Gum |
| Generic Name | Benzalkonium Chloride, Benzocaine, Menthol, Zinc Chloride |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2019-11-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part333A |
| Labeler Name | Church & Dwight Co., Inc. |
| Substance Name | BENZOCAINE; MENTHOL; BENZALKONIUM CHLORIDE; ZINC CHLORIDE |
| Active Ingredient Strength | 200 mg/g; mg/g; mg/g; mg/g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-11-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part333A |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-11-01 |
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/g |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10237-787 | Orajel 4X Medicated For Toothache and Gum | Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride |
| 10237-788 | Orajel 4X Medicated For Toothache and Gum, Cream | Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride |
| 10237-789 | Orajel 4X Medicated PM For Toothache and Gum | Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride |