Topicale Xtra
- Product NDC
- 10733-175
- 11-digit product format
- 107330175
- Labeler code
- 10733
- Product ID
- 10733-175_28dd1dbf-cda3-de75-e063-6294a90a48f6
- 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
- 2022-08-22
- Substance
- BENZOCAINE
- Active strength
- 200 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 Xtra
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 200 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5 |
| Rxcui | 238910, 864735 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10733-175-01 | Topicale Xtra | 28.35 g in 1 BOTTLE, PLASTIC | GEL | 28.35 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10733-175 | TOPICALE XTRA (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] | 4 | Current NDC, 1 package rows | 20241213_e3d924b5-0788-46d3-e053-2995a90a027b.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 |
|---|
| 10733-175-01 | 10733017501 | 28.35 g in 1 BOTTLE, PLASTIC (10733-175-01) | 28.35 g | 2022-08-22 | No | No | Historical |