Label: ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM liquid

  • NDC Code(s): 84778-079-01, 84778-079-02, 84778-079-03, 84778-079-04
  • Packager: Guangzhou Yixin Cross-border E-commerce Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 24, 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 prescription use only (Rx only).

    Do not use if you are taking any form of nitrate medications (such as nitroglycerin) due to the risk of severe hypotension.
    Do not use if allergic to tadalafil, vardenafil, or any component of this product.

  • Dosage and administration

    For external use only.

  • Do not use

    heart problems, history of heart attack, irregular heartbeat, or chest pain
    high or low blood pressure
    liver or kidney disease
    vision or hearing problems
    history of priapism (painful or prolonged erection lasting >4 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

    Pregnant or breastfeeding women
    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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84778-079
    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:84778-079-011 in 1 BOX08/24/2025
    140 mg in 1 PATCH; Type 0: Not a Combination Product
    2NDC:84778-079-022 in 1 BOX08/24/2025
    240 mg in 1 PATCH; Type 0: Not a Combination Product
    3NDC:84778-079-034 in 1 BOX08/24/2025
    340 mg in 1 PATCH; Type 0: Not a Combination Product
    4NDC:84778-079-048 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(84778-079) , label(84778-079)
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