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 73 of 82 · 1,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VirimmuneALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2021-2022), MORBILLINUMDeseret Biologicals, Inc.56555cb5-89e5-4a30-8ebe-ce2c01bdd4262023-01-03WarningsExact identifier
unii: 451W47IQ8X
BOLYM-EX DropsBENZOIC ACID, FORMIC ACID, ARISTOLOCHIA CLEMATITIS ROOT, FERULA ASSA-FOETIDA RESIN, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, CALCIUM PHOSPHATE, UNSPECIFIED FORM, CAPSELLA BURSA-PASTORIS, GALIUM APARINE, DAPHNE MEZEREUM BARK, AND PIPER METHYSTICUM ROOTPEKANA Naturheilmittel GmbH77ec6ee5-1c22-4799-b582-1c32056b14ff2022-12-23WarningsExact identifier
unii: 8SKN0B0MIM
AILGENOAMANITA MUSCARIA FRUITING BODY, ARSENIC TRIOXIDE, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, GLECHOMA HEDERACEA FLOWERING TOP, GRINDELIA HIRSUTULA WHOLE, AND SODIUM CHLORIDEPEKANA Naturheilmittel GmbH4e24f727-4c83-46b6-9549-8f66bd1356472022-12-21WarningsExact identifier
unii: 451W47IQ8X
Weight Management HPARSENIC TRIOXIDE, GOLD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, IODINE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SULFURNatural Creations, Inc.93736f0b-a419-4b90-84b0-f27e4c71299b2022-12-20WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDELiebel-Flarsheim Company LLCe4540d03-06b4-4b4d-b859-75c13e5c20dd2022-12-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NATRUM MURIATICUMSODIUM CHLORIDEHyland's Inc.21ee53eb-b41a-4d2e-8037-12973d2b73d92022-12-19WarningsExact identifier
unii: 451W47IQ8X
CataraccARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET.Newton Laboratories, Inc.eff981fd-5436-7c34-e053-2a95a90a3e8e2022-12-16WarningsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy4df47f14-8268-4cd3-b29e-96446743e2f62022-12-16WarningsExact identifier
unii: 451W47IQ8X
Cold and CoughONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALWal-Mart Stores, Inc.69349b4d-6c5b-7121-e053-2991aa0a35942022-12-15WarningsExact identifier
unii: 451W47IQ8X
Childrens Cold and Cough NighttimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEALWalgreen Company80c41b65-0411-4395-e053-2a91aa0a9df92022-12-15WarningsExact identifier
unii: 451W47IQ8X
Childrens Cold and CoughONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALWalgreen Company80b5f707-a839-7729-e053-2991aa0a1c562022-12-15WarningsExact identifier
unii: 451W47IQ8X
FERRODONNAARSENIC TRIOXIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, COBALTOUS NITRATE, CUPRIC SULFATE, IRON, MANGANESE ACETATE, AND SODIUM CHLORIDEPEKANA Naturheilmittel GmbH64c6f75a-382d-4aa0-b210-6be83a62fa3f2022-12-14WarningsExact identifier
unii: 451W47IQ8X
Nat MurSODIUM CHLORIDEHyland's Inc.d3ab4254-daaf-24ac-e053-2995a90afb8f2022-12-13WarningsExact identifier
unii: 451W47IQ8X
RestSILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIANHyland's Inc.5e9924be-4dad-324a-e053-2a91aa0a8ec12022-12-13WarningsExact identifier
unii: 451W47IQ8X
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7611e508-6da2-3a2f-e053-2a91aa0a9f402022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst763ff805-af1a-e8e9-e053-2a91aa0a82532022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2fae04e3-20b1-4b8c-b1fb-646b384836f12022-12-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
MET TOXARSENICUM ALB, AVENA, BERBERIS VULG, LYCOPODIUM, NAT MUR, NUX VOM, PHYTOLACCA, RHAMNUS FRANG, SOLIDAGO, TRIFOLIUM PRATWhite Manufacturing Inc. DBA Micro-West2653d62b-5dd7-482c-b31c-ce5fa13739002022-12-02WarningsExact identifier
unii: 451W47IQ8X
Miranda Castros Healing Gel for Bites and StingsCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS.OHM PHARMA INC.8e06aaa4-c177-45cf-9d8d-e0099de256682022-12-02WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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