{
"NDC": {
"NDCCode": "84778-085-03",
"PackageDescription": "4 PATCH in 1 BOX (84778-085-03) / 60 mg in 1 PATCH",
"NDC11Code": "84778-0085-03",
"ProductNDC": "84778-085",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esokalli Testosterone Booster Oral Dissolving Film",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Esokalli Testosterone Booster Oral Dissolving Film",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250824",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Guangzhou Yixin Cross-border E-commerce Co., Ltd.",
"SubstanceName": "TADALAFIL; VARDENAFIL",
"StrengthNumber": "40; 20",
"StrengthUnit": "mg/100mg; mg/100mg",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA], Phosphodiesterase 5 Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250824",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}