FDA.reportPublic FDA data

NDC 76357-599 - SmartMouth SmartMouth Gum Health Zinc Activated Formula

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
76357-599
Package NDCs from labels
76357-599-02
Manufacturer
Triumph Pharmaceuticals, Inc.
Effective date
2024-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SmartMouth Gum Health Solution 1 - Triumph Pharmaceuticals, Inc.Triumph Pharmaceuticals, Inc.2024-12-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-599-02SmartMouth SmartMouth Gum Health Zinc Activated Formula237 mL in 1 BOTTLELIQUID237 mL500 mg in 20mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-599SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.]2Unmatched20241215_c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 18 of 88 · 1,741 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Equate Healthy MouthCPC 0.05% ANTIPLAQUE/ANTI-GINGIVITISWalmart, Inc.1cc1f6fd-67d4-b314-e063-6294a90ab9952026-01-19WarningsExact identifier
unii: D9OM4SK49P
GuruNanda Anti-GingivitisCETYLPYRIDINIUM CHLORIDEGURUNANDA, LLC386f8d92-8186-eed7-e063-6394a90a87e12026-01-19WarningsExact identifier
rxcui: 1251617
unii: D9OM4SK49P
Up and Up AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation386ee9f9-598e-ad00-e063-6394a90aeb462026-01-19WarningsExact identifier
unii: D9OM4SK49P
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Hemorrhoids ReliefHORSE CHESTNUT,ALOE,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,NITRIC ACID,PAEONIA OFFICINALIS ROOT,SEPIA OFFICINALIS JUICE.Homeocare Laboratories0e9a1e8b-129f-496c-859b-d71332bd49182026-01-15WarningsExact identifier
unii: V5VD430YW9
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.