Comfortcaine Topical Anesthetic
- Product NDC
- 68400-458
- Requested package NDC
- 68400-458-30
- 11-digit product format
- 684000458
- Labeler code
- 68400
- Product ID
- 68400-458_d66f5dca-ff8b-25ca-e053-2995a90a2101
- 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
- part356
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2018-11-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68400-458-30 | 68400045830 | 30 g in 1 JAR (68400-458-30) | 30 g | 2018-11-01 | 0000-00-00 | No | No | Current |