<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80921-001-50
</NDCCode>
<PackageDescription>
1 TUBE in 1 CARTON (80921-001-50) / 50 mL in 1 TUBE
</PackageDescription>
<NDC11Code>
80921-0001-50
</NDC11Code>
<ProductNDC>
80921-001
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Skin Mercy Intense Recovery Cream
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Colloidal Oatmeal
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260102
</StartMarketingDate>
<EndMarketingDate>
20270401
</EndMarketingDate>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M016
</ApplicationNumber>
<LabelerName>
Cultskin Apothecary, Inc.
</LabelerName>
<SubstanceName>
OATMEAL
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
g/100mL
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20260102
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20270401
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>