iSmile Topical Anesthetic
- Product NDC
- 69498-001
- 11-digit product format
- 694980001
- Labeler code
- 69498
- Product ID
- 69498-001_2b4cf783-f620-9e0d-e063-6394a90a81ec
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- iSmile Dental Products, Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-06-01
- 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
- iSmile Topical Anesthetic
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69498-001-30 | iSmile Topical Anesthetic | 30 g in 1 JAR | GEL | 30 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69498-001 | ISMILE TOPICAL ANESTHETIC (BENZOCAINE) GEL [ISMILE DENTAL PRODUCTS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250112_a2591a96-ed66-45b1-abf6-6b26d0bb4f44.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 |
|---|
| 69498-001-30 | 69498000130 | 30 g in 1 JAR (69498-001-30) | 30 g | 2018-06-01 | 0000-00-00 | No | No | Current |