Orajel 4X Medicated For Toothache and Gum, Cream
- Product NDC
- 10237-788
- 11-digit product format
- 102370788
- Labeler code
- 10237
- Product ID
- 10237-788_45c2f5a1-7e8d-1fbd-e063-6394a90ab88f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-01
- Substance
- BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM; ZINC CATION
- Active strength
- 1.3; 200; 2.6; 1.5 mg/g; mg/g; mg/g; mg/g
- Pharmacologic 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
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orajel 4X Medicated For Toothache and Gum, Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | 1.3 mg/g |
| BENZOCAINE | 200 mg/g |
| MENTHOL, UNSPECIFIED FORM | 2.6 mg/g |
| ZINC CATION | 1.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7, U3RSY48JW5, L7T10EIP3A, 13S1S8SF37 |
| Rxcui | 2370903 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10237-788-33 | Orajel 4X Medicated For Toothache and Gum, Cream | 9.4 g in 1 TUBE | CREAM | 9.4 | | 7 |
| 10237-788-33 | Orajel 4X Medicated For Toothache and Gum, Cream | 1 in 1 CARTON | CREAM | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10237-788 | ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM, CREAM (BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE) CREAM [CHURCH & DWIGHT CO., INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241129_999aa7b9-bf9e-9285-e053-2a95a90a345b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10237-788-33 | 10237078833 | 1 TUBE in 1 CARTON (10237-788-33) / 9.4 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |