<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83817-102-01
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 BLISTER PACK (83817-102-01) / 8 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
83817-0102-01
</NDC11Code>
<ProductNDC>
83817-102
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Code Red Eye Drops
</ProprietaryName>
<ProprietaryNameSuffix>
Micro
</ProprietaryNameSuffix>
<NonProprietaryName>
Glycerin And Naphazoline Hydrochloride
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
CONJUNCTIVAL
</RouteName>
<StartMarketingDate>
20250331
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M018
</ApplicationNumber>
<LabelerName>
4 Trees LLC
</LabelerName>
<SubstanceName>
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
20; .96
</StrengthNumber>
<StrengthUnit>
mg/8mL; mg/8mL
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-05-31
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250331
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>