Indications and uses
For the treatment of erectile dysfunction (ED)
For the treatment of erectile dysfunction (ED)
• Take 1 oral film as a single dose. • Administer orally by placing on the tongue until dissolved. • Administer approximately 0.5 to 4 hours prior to anticipated sexual activity. • Do not exceed 1 dose in 24 hours.
Tadalafil 30 mg – Erectile dysfunction treatment
Vardenafil 10 mg – Erectile dysfunction treatment
Phosphodiesterase type 5 (PDE5) inhibitors
For the treatment of erectile dysfunction (ED)
For adult men only.
take nitrate medicines (such as nitroglycerin)
have severe heart disease or very low blood pressure
are allergic to tadalafil, vardenafil, or any ingredient in this product
have galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
• Take 1 oral film as a single dose.
• Administer orally by placing on the tongue until dissolved.
• Administer approximately 0.5 to 4 hours prior to anticipated sexual activity.
• Do not exceed 1 dose in 24 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.
Not for use in pregnant or breastfeeding women
Not for use in 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 |
|---|---|---|---|---|---|---|
| 84778-083-01 | Esokalli Testosterone Booster Oral Dissolving Film | 1 in 1 BOX | FILM, SOLUBLE | 1 | 4 | |
| 84778-083-01 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | 4 | |
| 84778-083-02 | Esokalli Testosterone Booster Oral Dissolving Film | 2 in 1 BOX | FILM, SOLUBLE | 2 | 4 | |
| 84778-083-02 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | 4 | |
| 84778-083-03 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | 4 | |
| 84778-083-03 | Esokalli Testosterone Booster Oral Dissolving Film | 4 in 1 BOX | FILM, SOLUBLE | 4 | 4 | |
| 84778-083-04 | Esokalli Testosterone Booster Oral Dissolving Film | 8 in 1 BOX | FILM, SOLUBLE | 8 | 4 | |
| 84778-083-04 | Esokalli Testosterone Booster Oral Dissolving Film | 40 mg in 1 PATCH | FILM, SOLUBLE | 40 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84778-083 | 84778-083-01, 84778-083-02, 84778-083-03, 84778-083-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| VARDENAFIL | UCE6F4125H | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
| TADALAFIL | 742SXX0ICT | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 3dca6977-1abb-ca76-e063-6294a90a25a9 | 3d710111-debf-ff99-e063-6294a90a3186 | 2025-09-01 | Warnings | 3dca6977-1abb-ca76-e063-6294a90a25a9 3d710111-debf-ff99-e063-6294a90a3186 |
Adverse event summaries are temporarily unavailable. Other product information remains available.