<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72863-076-01
</NDCCode>
<PackageDescription>
1 BOTTLE, WITH APPLICATOR in 1 CARTON (72863-076-01) / 50 mL in 1 BOTTLE, WITH APPLICATOR
</PackageDescription>
<NDC11Code>
72863-0076-01
</NDC11Code>
<ProductNDC>
72863-076
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Rael Pain Relief Roll-on
</ProprietaryName>
<ProprietaryNameSuffix>
Analgesic
</ProprietaryNameSuffix>
<NonProprietaryName>
Camphor (synthetic) And Menthol, Unspecified Form
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20241009
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
Rael, Inc.
</LabelerName>
<SubstanceName>
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
</SubstanceName>
<StrengthNumber>
40; 40
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241009
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>