Topicaine Ultra
- Product NDC
- 85477-307
- 11-digit product format
- 854770307
- Labeler code
- 85477
- Product ID
- 85477-307_39d5838a-c935-4447-a315-d27d91659444
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Topicaine Ultra
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Oncora Pharma, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-01
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topicaine Ultra
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE HYDROCHLORIDE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V13007Z41A |
| Rxcui | 1011852 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85477-307-85 | Topicaine Ultra | 85 g in 1 TUBE | GEL | 85 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85477-307-85 | 85477030785 | 85 g in 1 TUBE (85477-307-85) | 85 g | 2026-03-01 | No | No | Current |