Esokalli Testosterone Booster Oral Dissolving Film

Manufacturer
Guangzhou Yixin Cross-border E-commerce Co., Ltd.
Effective date
2025-09-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:12:21

Label at a glance#

ProductEsokalli Testosterone Booster Oral Dissolving Film
Active ingredientVARDENAFIL, TADALAFIL
Label structure11 sections

Indications and uses

For the treatment of erectile dysfunction (ED)

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active ingredients (in each film)

COMPONENTS

Tadalafil 30 mg – Erectile dysfunction treatment
Vardenafil 10 mg – Erectile dysfunction treatment

Purpose

OTC - PURPOSE SECTION

Phosphodiesterase type 5 (PDE5) inhibitors

Uses

INDICATIONS & USAGE SECTION

For the treatment of erectile dysfunction (ED)

Warnings

WARNINGS SECTION

For adult men only.

Do not use if you:

OTC - DO NOT USE SECTION

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

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

• 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.

When using this product you may experience:

OTC - WHEN USING SECTION

headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances

Stop use and ask a doctor if:

OTC - STOP USE SECTION

you experience chest pain, fainting, sudden vision or hearing loss
an erection lasts longer than 4 hours (priapism). This is a medical emergency.

Contraindications

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Not for use in pregnant or breastfeeding women
Not for use in children under 18 years

Inactive ingredients

INACTIVE INGREDIENT SECTION

Film-forming polymers, stabilizers, sweeteners, flavoring agents.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11223344

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TADALAFIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
VARDENAFIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84778-083-01Esokalli Testosterone Booster Oral Dissolving Film1 in 1 BOXFILM, SOLUBLE14
84778-083-01Esokalli Testosterone Booster Oral Dissolving Film40 mg in 1 PATCHFILM, SOLUBLE404
84778-083-02Esokalli Testosterone Booster Oral Dissolving Film2 in 1 BOXFILM, SOLUBLE24
84778-083-02Esokalli Testosterone Booster Oral Dissolving Film40 mg in 1 PATCHFILM, SOLUBLE404
84778-083-03Esokalli Testosterone Booster Oral Dissolving Film40 mg in 1 PATCHFILM, SOLUBLE404
84778-083-03Esokalli Testosterone Booster Oral Dissolving Film4 in 1 BOXFILM, SOLUBLE44
84778-083-04Esokalli Testosterone Booster Oral Dissolving Film8 in 1 BOXFILM, SOLUBLE84
84778-083-04Esokalli Testosterone Booster Oral Dissolving Film40 mg in 1 PATCHFILM, SOLUBLE404

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84778-08384778-083-01, 84778-083-02, 84778-083-03, 84778-083-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3dca6977-1abb-ca76-e063-6294a90a25a93d710111-debf-ff99-e063-6294a90a31862025-09-01WarningsExact identifier
spl id: 3dca6977-1abb-ca76-e063-6294a90a25a9
spl set id: 3d710111-debf-ff99-e063-6294a90a3186

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.