ESOKALLI Delay Performance Gel
- Product NDC
- 84778-103
- 11-digit product format
- 847780103
- Labeler code
- 84778
- Product ID
- 84778-103_42b2f99b-7bdf-cc56-e063-6294a90a27de
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ESOKALLI Delay Performance Gel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Guangzhou Yixin Cross-border E-commerce Co., Ltd.
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-24
- Substance
- ARGININE; LIDOCAINE
- Active strength
- .1; 2 g/100mL; g/100mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESOKALLI Delay Performance Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARGININE | .1 g/100mL |
| LIDOCAINE | 2 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 94ZLA3W45F, 98PI200987 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84778-103-01 | ESOKALLI Delay Performance Gel | 1.8 mL in 1 TUBE | GEL | 1.8 | | 4 |
| 84778-103-01 | ESOKALLI Delay Performance Gel | 1 in 1 BOX | GEL | 1 | | 4 |
| 84778-103-02 | ESOKALLI Delay Performance Gel | 1.8 mL in 1 TUBE | GEL | 1.8 | | 4 |
| 84778-103-02 | ESOKALLI Delay Performance Gel | 2 in 1 BOX | GEL | 2 | | 4 |
| 84778-103-03 | ESOKALLI Delay Performance Gel | 1.8 mL in 1 TUBE | GEL | 1.8 | | 4 |
| 84778-103-03 | ESOKALLI Delay Performance Gel | 3 in 1 BOX | GEL | 3 | | 4 |
| 84778-103-04 | ESOKALLI Delay Performance Gel | 1.8 mL in 1 TUBE | GEL | 1.8 | | 4 |
| 84778-103-04 | ESOKALLI Delay Performance Gel | 4 in 1 BOX | GEL | 4 | | 4 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84778-103-01 | 84778010301 | 1 TUBE in 1 BOX (84778-103-01) / 1.8 mL in 1 TUBE | 1 tube | 2025-08-24 | No | No | Historical |
| 84778-103-02 | 84778010302 | 2 TUBE in 1 BOX (84778-103-02) / 1.8 mL in 1 TUBE | 2 tube | 2025-08-24 | No | No | Historical |
| 84778-103-03 | 84778010303 | 3 TUBE in 1 BOX (84778-103-03) / 1.8 mL in 1 TUBE | 3 tube | 2025-08-24 | No | No | Historical |
| 84778-103-04 | 84778010304 | 4 TUBE in 1 BOX (84778-103-04) / 1.8 mL in 1 TUBE | 4 tube | 2025-08-24 | No | No | Historical |