FDA.reportPublic FDA data

NDC 76357-290 - SmartMouth Clinical Gum and Plaque 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
76357-290
Package NDCs from labels
76357-290-01
Manufacturer
Triumph Pharmaceuticals Inc.
Effective date
2024-12-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SmartMouth Gum and Plaque Solution 1 - Triumph Pharmaceuticals Inc.Triumph Pharmaceuticals Inc.2024-12-11HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-290-01SmartMouth Clinical Gum and Plaque Formula296 mL in 1 BOTTLE, PLASTICLIQUID296 mL500 mg in 20mL8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-290SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS INC.]8Unmatched20241215_0f836ac2-eb0e-483f-9374-ec8e511e32b6.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 15 of 83 · 1,651 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 451W47IQ8X
MintCETYLPYRIDINIUM CHLORIDEBetter Living Brands, LLC4af3b64e-060e-4c0f-a39b-f0bfb92dceb82026-02-23WarningsExact identifier
unii: D9OM4SK49P
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
AntisepticCETYLPYRIDINIUM CHLORIDEPerrigo Direct, Inc4d452c85-8e28-4915-a638-c71fc9cc77d62026-02-19Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
MintCETYLPYRIDINIUM CHLORIDEMeijer, Inc.de72012b-c5f5-4883-865e-3bc8d075ef842026-02-19Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation51d2100a-bbd8-4937-aa2a-a49a1224f43b2026-02-18Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Equaline Multi-Action AntisepticCETYLPYRIDINIUM CHLORIDEUnited Natural Foods, Inc. dba UNFI138d04b5-0b35-45f0-87a1-7a90cef2a9bc2026-02-17Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
ANTISEPTICCETYLPYRIDINIUM CHLORIDEValu Merchandisers Company34f1e92a-be34-4da1-84da-3e8a2a74693b2026-02-16Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
AntisepticCETYLPYRIDINIUM CHLORIDETopco Associates LLC857e8bc4-125f-4796-ac10-6880702816fe2026-02-13Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDETopco Associates LLCc20cbcca-1509-491b-9ec4-3d9611b311592026-02-13Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDETopco Associates LLC3fefe9b3-d61d-494d-bd85-5d2cf83213982026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 1251617
unii: D9OM4SK49P
Mint Alcohol FreeCETYLPYRIDINIUM CHLORIDEWinCo Foods LLC30b50da5-14d0-d0c7-e063-6394a90a091b2026-02-12Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
AntisepticCETYLPYRIDINIUM CHLORIDEYour Military Exchangese1fe5fd5-e0a9-428f-82a4-fdf7486a529c2026-02-12Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
HealthCETYLPYRIDINIUM CHLORIDEWalgreen Co.698f7c5a-11d4-4ea9-811d-9c2ffb4df71e2026-02-12Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Cetylpyridinium ChlorideCETYLPYRIDINIUM CHLORIDEWalgreen Co.476df2f5-42fa-edc2-e063-6294a90a7b5c2026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 1251617
unii: D9OM4SK49P
CVS AntisepticCETYLPYRIDINIUM CHLORIDECVS Pharmacy, Inc.60f6a6b5-a3d6-49fc-9543-113ef0205dd22026-02-11Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P

Reported adverse events (FAERS/openFDA)#

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