<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87843-311-50
</NDCCode>
<PackageDescription>
50 mL in 1 BOTTLE, PLASTIC (87843-311-50)
</PackageDescription>
<NDC11Code>
87843-0311-50
</NDC11Code>
<ProductNDC>
87843-311
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Freeze Ease Roll-on
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Menthol
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260901
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
Global America Group LLC
</LabelerName>
<SubstanceName>
MENTHOL, UNSPECIFIED FORM
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-09-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260901
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>