<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84423-077-01
</NDCCode>
<PackageDescription>
250 g in 1 BOX (84423-077-01)
</PackageDescription>
<NDC11Code>
84423-0077-01
</NDC11Code>
<ProductNDC>
84423-077
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Papaya Glutasoap
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Papayaglutasoap
</NonProprietaryName>
<DosageFormName>
SOAP
</DosageFormName>
<RouteName>
CUTANEOUS
</RouteName>
<StartMarketingDate>
20250219
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M016
</ApplicationNumber>
<LabelerName>
Guangzhou Kadiya Biotechnology Co., Ltd.
</LabelerName>
<SubstanceName>
CARICA PAPAYA (PAPAYA) FRUIT; PAPAYA SEED OIL
</SubstanceName>
<StrengthNumber>
.5; 1.25
</StrengthNumber>
<StrengthUnit>
g/250g; g/250g
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-02-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250219
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>