Orajel 4X Medicated PM For Toothache and Gum
- Product NDC
- 10237-789
- 11-digit product format
- 102370789
- Labeler code
- 10237
- Product ID
- 10237-789_45c30015-1521-2ab6-e063-6294a90ac193
- 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 CHLORIDE
- 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 PM For Toothache and Gum
- 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 CHLORIDE | 1.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7, U3RSY48JW5, L7T10EIP3A, 86Q357L16B |
| Rxcui | 2370903 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10237-789-25 | Orajel 4X Medicated PM For Toothache and Gum | 1 in 1 CARTON | CREAM | 1 | | 9 |
| 10237-789-25 | Orajel 4X Medicated PM For Toothache and Gum | 7 g in 1 TUBE | CREAM | 7 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10237-789 | ORAJEL 4X MEDICATED PM FOR TOOTHACHE AND GUM (BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE) CREAM [CHURCH & DWIGHT CO., INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241129_999cff2b-c23e-5abe-e053-2a95a90a7569.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 |
|---|
| 10237-789-25 | 10237078925 | 1 TUBE in 1 CARTON (10237-789-25) / 7 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |