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 80 of 82 · 1,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA ALLERGYADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -Guna spaae6bd80d-2c70-1a3f-e053-2a95a90a26522020-10-23WarningsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PURE O2 Pack-SolidSODIUM CHLORITEPure O2a397afb9-53a7-e6d8-e053-2a95a90a54d42020-08-29WarningsExact identifier
unii: G538EBV4VF
QVE - SSODIUM CHLORITEPure O2acdeca69-4e20-9502-e053-2a95a90a53272020-08-14WarningsExact identifier
unii: G538EBV4VF
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstac0fd44a-3f39-8d7e-e053-2995a90afeec2020-08-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CardioplegicCALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Corporation1fd50ce5-2799-4c26-81da-02cf0578dd9e2020-06-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta62b71db-8ba2-6f6b-e053-2a95a90a29d12020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERS AND DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirsta62cf623-9b8a-37e0-e053-2995a90add5b2020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Hay FeverAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENSNewton Laboratories, Inc.a6045b91-d361-2731-e053-2a95a90a97722020-05-18WarningsExact identifier
unii: 451W47IQ8X
Isolyte SSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.7e8fe27f-ff82-48c1-9bf6-3c589c8e985d2020-05-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DrainageCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Xymogena526f4ac-1630-c122-e053-2995a90a6a272020-05-08WarningsExact identifier
unii: 8SKN0B0MIM
V Doctor pure chlorine dioxideSODIUM CHLORITEPure O2a492a03c-c28e-fcd6-e053-2a95a90a65d42020-05-01WarningsExact identifier
unii: G538EBV4VF
DEXTROSE AND SODIUM CHLORIDEDEXTROSE MONOHYDRATE, SODIUM CHLORIDEFresenius Kabi USA, LLCb825c9c4-f2fb-4a4a-9d8c-fb020ad07e932020-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2b8220f-e33a-51c3-e053-2995a90a07342020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2bba76a-08ce-6902-e053-2995a90ab9c92020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationfbc01464-8885-4075-af41-911ffec5ae922020-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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