Orajel Cold Sore Touch Free - Single Dose
- Product NDC
- 10237-798
- 11-digit product format
- 102370798
- Labeler code
- 10237
- Product ID
- 10237-798_51b6fb8e-eeba-a04a-e063-6294a90a610f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium Chloride, Benzocaine
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-09-01
- Substance
- BENZALKONIUM CHLORIDE; BENZOCAINE
- Active strength
- 1.3; 50 mg/mL; mg/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orajel Cold Sore Touch Free - Single Dose
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | 1.3 mg/mL |
| BENZOCAINE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7, U3RSY48JW5 |
| Rxcui | 2572114 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10237-798-35 | Orajel Cold Sore Touch Free - Single Dose | 3.5 mL in 1 VIAL, SINGLE-DOSE | LIQUID | 3.5 | | 6 |
| 10237-798-35 | Orajel Cold Sore Touch Free - Single Dose | 6 in 1 PACKAGE | LIQUID | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10237-798 | ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE (BENZALKONIUM CHLORIDE, BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250330_ce40829e-941f-2548-e053-2995a90a1e0e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10237-798-35 | 10237079835 | 6 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-798-35) / 3.5 mL in 1 VIAL, SINGLE-DOSE | 2021-09-01 | 0000-00-00 | No | No | Current |