Topicale
- Product NDC
- 10733-166
- 11-digit product format
- 107330166
- Labeler code
- 10733
- Product ID
- 10733-166_28dd05fd-da61-a52d-e063-6394a90afe83
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Medical Products Laboratories, Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-05
- Substance
- BENZOCAINE
- Active strength
- 180 mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [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
- Topicale
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 180 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5 |
| Rxcui | 1042838, 1049213 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10733-166-35 | Topicale | 35 g in 1 CARTON | GEL | 35 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10733-166 | TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] | 4 | Current NDC, 1 package rows | 20241213_826eaef8-4457-3dc2-e053-2991aa0a528b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 10733-166-35 | 10733016635 | 35 g in 1 CARTON (10733-166-35) | 35 g | 2019-03-05 | No | No | Current |