<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
57619-300-01
</NDCCode>
<PackageDescription>
1 BOTTLE, PLASTIC in 1 PACKAGE (57619-300-01) > 15 mL in 1 BOTTLE, PLASTIC
</PackageDescription>
<NDC11Code>
57619-0300-01
</NDC11Code>
<ProductNDC>
57619-300
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Nazil
</ProprietaryName>
<ProprietaryNameSuffix>
Ofteno
</ProprietaryNameSuffix>
<NonProprietaryName>
Naphazoline Hydrochloride
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20100412
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH FINAL
</MarketingCategoryName>
<ApplicationNumber>
part349
</ApplicationNumber>
<LabelerName>
LABORATORIOS SOPHIA, S.A. DE C.V.
</LabelerName>
<SubstanceName>
NAPHAZOLINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
.2
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2015-08-28
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>