{
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"PackageDescription": "25 POUCH in 1 CARTON (0121-1077-25) / 1 APPLICATOR in 1 POUCH (0121-1077-01) / .5 mL in 1 APPLICATOR",
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"ProductNDC": "0121-1077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzocaine 20%",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Benzocaine 20%",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260320",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}