Esokalli Testosterone Booster Oral Dissolving Film
- Product NDC
- 84778-092
- 11-digit product format
- 847780092
- Labeler code
- 84778
- Product ID
- 84778-092_464bcdee-9535-2a99-e063-6394a90aebc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esokalli Testosterone Booster Oral Dissolving Film
- Dosage form
- FILM, SOLUBLE
- 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
- TADALAFIL; VARDENAFIL
- Active strength
- 30; 10 mg/100mg; mg/100mg
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esokalli Testosterone Booster Oral Dissolving Film
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 30 mg/100mg |
| VARDENAFIL | 10 mg/100mg |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT, UCE6F4125H |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84778-092-01 | Esokalli Testosterone Booster Oral Dissolving Film | 1 in 1 BOX | FILM, SOLUBLE | 1 | | 2 |
| 84778-092-01 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | | 2 |
| 84778-092-02 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | | 2 |
| 84778-092-02 | Esokalli Testosterone Booster Oral Dissolving Film | 2 in 1 BOX | FILM, SOLUBLE | 2 | | 2 |
| 84778-092-03 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | | 2 |
| 84778-092-03 | Esokalli Testosterone Booster Oral Dissolving Film | 4 in 1 BOX | FILM, SOLUBLE | 4 | | 2 |
| 84778-092-04 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | | 2 |
| 84778-092-04 | Esokalli Testosterone Booster Oral Dissolving Film | 8 in 1 BOX | FILM, SOLUBLE | 8 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84778-092-01 | 84778009201 | 1 PATCH in 1 BOX (84778-092-01) / 40 mg in 1 PATCH | 1 patch | 2025-08-24 | No | No | Historical |
| 84778-092-02 | 84778009202 | 2 PATCH in 1 BOX (84778-092-02) / 40 mg in 1 PATCH | 2 patch | 2025-08-24 | No | No | Historical |
| 84778-092-03 | 84778009203 | 4 PATCH in 1 BOX (84778-092-03) / 40 mg in 1 PATCH | 4 patch | 2025-08-24 | No | No | Historical |
| 84778-092-04 | 84778009204 | 8 PATCH in 1 BOX (84778-092-04) / 40 mg in 1 PATCH | 8 patch | 2025-08-24 | No | No | Historical |