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 72 of 82 · 1,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 451W47IQ8X
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HKIATROPINUM SULPHURICUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, CALCAREA CARBONICA, COLOCYNTHIS, COCCUS CACTI, LAPIS ALBUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, ORYCTOLAGUS CUNICULUS KIDNEY, RUBIA TINCTORUM, SARSAPARILLA, URTICA URENSSeroyal USA26e048f5-8e87-51e6-e054-00144ff88e882023-01-31WarningsExact identifier
unii: 8SKN0B0MIM
Natrum muriaticumSODIUM CHLORIDEBoiron86463b98-58f5-7f65-e053-2a91aa0ad3a22023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645f130-6a19-ae73-e053-2991aa0ab05b2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645eb60-65d1-9d6c-e053-2991aa0a94ef2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0e6-5c06-e053-2a91aa0ae83d2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466614-b8ee-2335-e053-2a91aa0aa67c2023-01-23Exact identifier
unii: 451W47IQ8X
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
unii: 86Q357L16B
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALSab40b62b-9f8d-4394-92d5-09d9f1941eaa2023-01-16Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: 8SKN0B0MIM
AKUTURBENZOIC ACID, NITRIC ACID, APIS MELLIFERA, LYTTA VESICATORIA, POPULUS TREMULOIDES BARK, ANEMONE PRATENSIS FLOWERING TOP, GINGER, AND SOLIDAGO VIRGAUREA FLOWERING TOPPEKANA Nautrheilmittel GmbH7facf36e-c26e-4bc3-a4c1-74e9409f25352023-01-11WarningsExact identifier
unii: 8SKN0B0MIM
RENELIXBENZOIC ACID, NITRIC ACID, APIS MELLIFERA, BERBERIS VULGARIS ROOT BARK, COLCHICUM AUTUMNALE BULB, PROTORTONIA CACTI, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CAPSELLA BURSA-PASTORIS TOPPEKANA Naturheilmittel GmbH11a057e9-4b2a-4de0-a7e9-fbd4029bb7a82023-01-11WarningsExact identifier
unii: 8SKN0B0MIM
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
PSORIASISARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMZorex Internationalb5b8bb82-4d36-4faa-b023-e48066f4521c2023-01-09WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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