ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM film, soluble

Esokalli Testosterone Booster Oral Dissolving Film by

Drug Labeling and Warnings

Esokalli Testosterone Booster Oral Dissolving Film by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yixin Cross-border E-commerce Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each film)

Tadalafil 40 mg – Erectile dysfunction treatment
Vardenafil 20 mg – Erectile dysfunction treatment

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

Uses

For the treatment of erectile dysfunction (ED)

Warnings

For adult men only.

Do not use if you:

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

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:

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

Stop use and ask a doctor if:

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

Contraindications

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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM 
esokalli testosterone booster oral dissolving film film, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84778-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)	TADALAFIL	40 mg  in 100 mg
VARDENAFIL (UNII: UCE6F4125H) (VARDENAFIL - UNII:UCE6F4125H)	VARDENAFIL	20 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84778-085-01	1 in 1 BOX	08/24/2025
1		60 mg in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 84778-085-02	2 in 1 BOX	08/24/2025
2		60 mg in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 84778-085-03	4 in 1 BOX	08/24/2025
3		60 mg in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 84778-085-04	8 in 1 BOX	08/24/2025
4		60 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/24/2025

Labeler - Guangzhou Yixin Cross-border E-commerce Co., Ltd. (455800881)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yixin Cross-border E-commerce Co., Ltd.		455800881	manufacture(84778-085) , label(84778-085)