<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84831-096-01
</NDCCode>
<PackageDescription>
100000 mg in 1 TUBE (84831-096-01)
</PackageDescription>
<NDC11Code>
84831-0096-01
</NDC11Code>
<ProductNDC>
84831-096
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Coca Lief
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Menthol, Methylsalicylate
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250120
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED HOMEOPATHIC
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.
</LabelerName>
<SubstanceName>
MENTHOL; METHYL SALICYLATE
</SubstanceName>
<StrengthNumber>
1500; 12500
</StrengthNumber>
<StrengthUnit>
mg/100000mg; mg/100000mg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-01-21
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250120
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>