Gelato Topical Anesthetic
- Product NDC
- 68400-323
- 11-digit product format
- 684000323
- Labeler code
- 68400
- Product ID
- 68400-323_15d7eb39-c284-291a-e063-6294a90adc6a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- SPRAY, METERED
- Route
- DENTAL
- Labeler
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-07-29
- Substance
- BENZOCAINE
- Active strength
- 11.4 g/57g
- 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
- Gelato Topical Anesthetic
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 11.4 g/57g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5 |
| Rxcui | 1435490, 1435495 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68400-323-35 | Gelato Topical Anesthetic | 57 g in 1 BOTTLE, SPRAY | SPRAY, METERED | 57 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68400-323 | GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241222_9991de96-99a1-42f0-9ddd-e530ca9ceab1.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 |
|---|
| 68400-323-35 | 68400032335 | 57 g in 1 BOTTLE, SPRAY (68400-323-35) | 57 g | 2018-09-01 | 0000-00-00 | No | No | Current |