Orajel 4X Medicated For Toothache and Gum, Cream is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzalkonium Chloride; Benzocaine; Menthol, Unspecified Form; Zinc Cation.
| Product ID | 10237-788_821f2e07-a85d-46dd-b11d-bd3c13376342 |
| NDC | 10237-788 |
| Product Type | Human Otc Drug |
| Proprietary Name | Orajel 4X Medicated For Toothache and Gum, Cream |
| Generic Name | Benzalkonium Chloride, Benzocaine, Menthol, Zinc Chloride |
| Dosage Form | Cream |
| 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 | BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM; ZINC CATION |
| Active Ingredient Strength | 1 mg/g; mg/g; mg/g; mg/g |
| Pharm Classes | Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2024-12-31 |
| 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 |
|---|---|
| BENZALKONIUM CHLORIDE | 1.3 mg/g |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10237-788 | Orajel 4X Medicated For Toothache and Gum, Cream | Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride |
| 10237-787 | Orajel 4X Medicated For Toothache and Gum | Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride |
| 10237-789 | Orajel 4X Medicated PM For Toothache and Gum | Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride |