<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
76472-7005-2
</NDCCode>
<PackageDescription>
1 BOTTLE, SPRAY in 1 BOX (76472-7005-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7005-1)
</PackageDescription>
<NDC11Code>
76472-7005-02
</NDC11Code>
<ProductNDC>
76472-7005
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Smooth Breath
</ProprietaryName>
<ProprietaryNameSuffix>
Spasmodic Cough
</ProprietaryNameSuffix>
<NonProprietaryName>
Bryonia 5c, Drosera 5c, Mentha Piperita 3c, Spongia Tosta 5c, Verbascum Thapsus 3c, Viola Odorata 3c
</NonProprietaryName>
<DosageFormName>
SPRAY
</DosageFormName>
<RouteName>
BUCCAL
</RouteName>
<StartMarketingDate>
20260819
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED HOMEOPATHIC
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
SEVENE USA
</LabelerName>
<SubstanceName>
VERBASCUM THAPSUS WHOLE; DROSERA ROTUNDIFOLIA WHOLE; BRYONIA CRETICA SUBSP. DIOICA ROOT; MENTHA PIPERITA; SPONGIA OFFICINALIS WHOLE; VIOLA ODORATA WHOLE
</SubstanceName>
<StrengthNumber>
.1; .1; .1; .1; .1; .1
</StrengthNumber>
<StrengthUnit>
mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-08-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260819
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>