<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85956-624-00
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BOX (85956-624-00) / 30 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
85956-0624-00
</NDC11Code>
<ProductNDC>
85956-624
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Comfort Candy Hemorrhoidal
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lidocaine, Phenylephrine Hydrochloride
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250620
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M015
</ApplicationNumber>
<LabelerName>
BOWLER ESTHETICS, INC
</LabelerName>
<SubstanceName>
LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
50; 2.5
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250620
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>