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 77 of 82 · 1,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix75826e2a-737a-43ac-aed7-fad960889b882021-12-15WarningsExact identifier
unii: 451W47IQ8X
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.d5c75dc2-9edc-429e-8f25-e5641fe5042f2021-11-23WarningsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.e4f06c0b-7cb1-49c9-97a4-2cfc212984952021-11-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CONSTIPATION CPALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.Natural Creations, Inc.961b3ddf-41fe-46ed-b5e4-0fd8d9652edf2021-11-15WarningsExact identifier
unii: 451W47IQ8X
CENTROCODEAMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE.Natural Creations, Inc.e5bbe9ec-7602-4de5-907a-7047c10198b62021-11-15WarningsExact identifier
unii: 451W47IQ8X
OHM-ANXARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, MOSCHUS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, STANNUM METALLICUM, VALERIANA OFFICINALISOHM PHARMA INC.f743b690-8f79-4e60-81cd-e3e2825a1ec82021-11-15WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc52cb98dc-6858-42bf-9c54-d20fb607dfbb2021-11-12WarningsExact identifier
unii: 451W47IQ8X
Adrenal and DHEAARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.ProBLEN44991952-c440-4a33-9423-a9369c8bab702021-10-22WarningsExact identifier
unii: 451W47IQ8X
Dr. Talbots Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLC.91c2795d-4cde-6e2c-e053-2995a90a00962021-10-05WarningsExact identifier
unii: 451W47IQ8X
Solucion InterSolSOLUCION ADITIVA PARA PLAQUETAS 3Fenwal, Inc.d5eaf5f4-67d3-4475-af9a-f5b0f882f5d12021-10-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NATRUM MURIATICUMNATRUM MURIATICUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc520edb18-5f2a-4448-ba53-83408a839e1f2021-09-02WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lactated Ringers IrrigationSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEB. Braun Medical Inc.0db56c7a-2b8f-4593-8591-2c481c92b2cf2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride for IrrigationSODIUM CHLORIDE FOR IRRIGATIONB. Braun Medical Inc.5bd9b176-0402-4a3f-a6b4-c3f393fc092a2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstc755e41b-acba-7234-e053-2995a90aff0f2021-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: 451W47IQ8X
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC4a655cde-283f-4ec8-a3d9-5f539c55c2042021-05-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCed8fd0c1-ac42-4267-877e-ceadf3831c902021-04-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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