Label: ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM film, soluble

  • NDC Code(s): 84778-091-01, 84778-091-02, 84778-091-03, 84778-091-04
  • Packager: Guangzhou Yixin Cross-border E-commerce Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2025

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  • Active ingredients (in each film)

    Tadalafil 20 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

    1234

  • INGREDIENTS AND APPEARANCE
    ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM 
    esokalli testosterone booster oral dissolving film film, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84778-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL20 mg  in 100 mg
    VARDENAFIL (UNII: UCE6F4125H) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL20 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84778-091-011 in 1 BOX08/24/2025
    140 mg in 1 PATCH; Type 0: Not a Combination Product
    2NDC:84778-091-022 in 1 BOX08/24/2025
    240 mg in 1 PATCH; Type 0: Not a Combination Product
    3NDC:84778-091-034 in 1 BOX08/24/2025
    340 mg in 1 PATCH; Type 0: Not a Combination Product
    4NDC:84778-091-048 in 1 BOX08/24/2025
    440 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/24/2025
    Labeler - Guangzhou Yixin Cross-border E-commerce Co., Ltd. (455800881)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yixin Cross-border E-commerce Co., Ltd.455800881manufacture(84778-091) , label(84778-091)
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