Comfortcaine Topical Anesthetic
- Product NDC
- 68400-461
- 11-digit product format
- 684000461
- Labeler code
- 68400
- Product ID
- 68400-461_2b4ee13e-8116-b671-e063-6294a90a9fb0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-11-01
- 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
- Comfortcaine 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68400-461-30 | Comfortcaine Topical Anesthetic | 30 g in 1 JAR | GEL | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68400-461 | COMFORTCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250119_fda3d254-e103-4be9-9086-51ad022b2b3f.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 |
|---|
| 68400-461-30 | 68400046130 | 30 g in 1 JAR (68400-461-30) | 30 g | 2018-11-01 | 0000-00-00 | No | No | Current |