Indications and uses
For the treatment of erectile dysfunction (ED)
For the treatment of erectile dysfunction (ED)
For external use only.
Tadalafil 20 mg – Erectile dysfunction treatment
Vardenafil 20 mg – Erectile dysfunction treatment
Phosphodiesterase type 5 (PDE5) inhibitors
For the treatment of erectile dysfunction (ED)
For prescription use only (Rx only).
Do not use if you are taking any form of nitrate medications (such as nitroglycerin) due to the risk of severe hypotension.
Do not use if allergic to tadalafil, vardenafil, or any component of this product.
For external use only.
heart problems, history of heart attack, irregular heartbeat, or chest pain
high or low blood pressure
liver or kidney disease
vision or hearing problems
history of priapism (painful or prolonged erection lasting >4 hours)
headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances
you experience chest pain, fainting, sudden vision or hearing loss
an erection lasts longer than 4 hours (priapism). This is a medical emergency.
Pregnant or breastfeeding women
Children under 18 years
Film-forming polymers, stabilizers, sweeteners, flavoring agents.
| Class | Version | Type | Effective |
|---|---|---|---|
| TADALAFIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| VARDENAFIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b90b74cb-f6c8-3798-d11c-73b8768b278a | Product name | 8 | 20250317 |
| 0fe0157c-95a7-4870-ae64-de9f3fa874ae | Product name | 1 | 20250227 |
| 20ae0006-d78c-4dba-9e3e-6ae424841903 | Product name | 1 | 20250127 |
| b86a08b7-54cc-440b-ad4a-3e530ccd8324 | Product name | 6 | 20230421 |
| 7a02e74a-2844-42af-84a8-96bae57351cf | Product name | 1 | 20230313 |
| 928d249c-35c3-4d88-a9ef-cf2f2e31b96f | Product name | 1 | 20220706 |
| f2f15561-f1f1-39f4-fff4-873c88c535cd | Product name | 4 | 20210224 |
| 9c8b57d3-6030-411c-8a17-97b4b8f0ea17 | Product name | 3 | 20200708 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84778-079-01 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | LIQUID | 40 | 1 | |
| 84778-079-01 | Esokalli Testosterone Booster Oral Dissolving Film | 1 in 1 BOX | LIQUID | 1 | 1 | |
| 84778-079-02 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | LIQUID | 40 | 1 | |
| 84778-079-02 | Esokalli Testosterone Booster Oral Dissolving Film | 2 in 1 BOX | LIQUID | 2 | 1 | |
| 84778-079-03 | Esokalli Testosterone Booster Oral Dissolving Film | 4 in 1 BOX | LIQUID | 4 | 1 | |
| 84778-079-03 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | LIQUID | 40 | 1 | |
| 84778-079-04 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | LIQUID | 40 | 1 | |
| 84778-079-04 | Esokalli Testosterone Booster Oral Dissolving Film | 8 in 1 BOX | LIQUID | 8 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84778-079 | 84778-079-01, 84778-079-02, 84778-079-03, 84778-079-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TADALAFIL | 742SXX0ICT | ACTIB |
| VARDENAFIL | UCE6F4125H | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3d1ee1c9-96ac-2a0f-e063-6394a90a3eb9 | 3d1ee1c9-96ab-2a0f-e063-6394a90a3eb9 | 2025-08-24 | Warnings | 3d1ee1c9-96ac-2a0f-e063-6394a90a3eb9 3d1ee1c9-96ab-2a0f-e063-6394a90a3eb9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.