<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
76420-253-04
</NDCCode>
<PackageDescription>
1 TUBE in 1 BOX (76420-253-04) > 99.2 g in 1 TUBE
</PackageDescription>
<NDC11Code>
76420-0253-04
</NDC11Code>
<ProductNDC>
76420-253
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lidothol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lidocaine Hcl, Menthol
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20190401
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Asclemed USA, Inc.
</LabelerName>
<SubstanceName>
LIDOCAINE HYDROCHLORIDE; MENTHOL
</SubstanceName>
<StrengthNumber>
4.5; 5
</StrengthNumber>
<StrengthUnit>
g/100g; g/100g
</StrengthUnit>
<Pharm_Classes>
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2022-09-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220719
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>