Esokalli Testosterone Booster Oral Dissolving Film — v1

Esokalli Testosterone Booster Oral Dissolving Film

9 Views

Version

v1

Effective date

September 23, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
3f80b924-c8e8-b048-e063-6294a90a219e
Set ID
3f80b8cc-5140-a70e-e063-6394a90ac265
Application numbers
505G(a)(3)
Product NDCs
84778-092
Package NDCs
84778-092-01, 84778-092-02, 84778-092-03, 84778-092-04
Original packager NDCs
—

Names & Manufacturers

Brand names
Esokalli Testosterone Booster Oral Dissolving Film
Generic names
ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM
Manufacturer names
Guangzhou Yixin Cross-border E-commerce Co., Ltd.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
TADALAFIL, VARDENAFIL
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
Phosphodiesterase 5 Inhibitor [EPC]
Pharmacologic class (CS)
—
Mechanism of action
Phosphodiesterase 5 Inhibitors [MoA]

Other identifiers

NUI
N0000020026, N0000175599
RxCUI
—
UNII
742SXX0ICT, UCE6F4125H
UPC
—

Structured Label Sections

Components (1)

Sequence 1

Active ingredients (in each film) Tadalafil 30 mg – Erectile dysfunction treatment Vardenafil 10 mg – Erectile dysfunction treatment
Do Not Use (1)

Sequence 1

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 (1)

Sequence 1

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.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients Film-forming polymers, stabilizers, sweeteners, flavoring agents.
Indications And Usage (1)

Sequence 1

Uses For the treatment of erectile dysfunction (ED)
Keep Out Of Reach Of Children (1)

Sequence 1

Contraindications Not for use in pregnant or breastfeeding women Not for use in children under 18 years
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL 1 2 3 4
Purpose (1)

Sequence 1

Purpose Phosphodiesterase type 5 (PDE5) inhibitors
Spl Product Data Elements (1)

Sequence 1

Esokalli Testosterone Booster Oral Dissolving Film Esokalli Testosterone Booster Oral Dissolving Film VARDENAFIL VARDENAFIL HYPROMELLOSES SUCRALOSE SUCROSE TADALAFIL TADALAFIL
Stop Use (1)

Sequence 1

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.
Warnings (1)

Sequence 1

Warnings For adult men only.
When Using (1)

Sequence 1

When using this product you may experience: headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances

OpenFDA raw payload

{'application_number': ['505G(a)(3)'],
 'brand_name': ['Esokalli Testosterone Booster Oral Dissolving Film'],
 'generic_name': ['ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM'],
 'is_original_packager': [True],
 'manufacturer_name': ['Guangzhou Yixin Cross-border E-commerce Co., Ltd.'],
 'nui': ['N0000175599', 'N0000020026'],
 'package_ndc': ['84778-092-01',
                 '84778-092-02',
                 '84778-092-03',
                 '84778-092-04'],
 'pharm_class_epc': ['Phosphodiesterase 5 Inhibitor [EPC]'],
 'pharm_class_moa': ['Phosphodiesterase 5 Inhibitors [MoA]'],
 'product_ndc': ['84778-092'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3f80b924-c8e8-b048-e063-6294a90a219e'],
 'spl_set_id': ['3f80b8cc-5140-a70e-e063-6394a90ac265'],
 'substance_name': ['TADALAFIL', 'VARDENAFIL'],
 'unii': ['742SXX0ICT', 'UCE6F4125H']}