FDA.reportPublic FDA data

NDC 76357-599 - SmartMouth SmartMouth Gum Health Zinc Activated 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
76357-599
Package NDCs from labels
76357-599-02
Manufacturer
Triumph Pharmaceuticals, Inc.
Effective date
2024-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-599-02SmartMouth SmartMouth Gum Health Zinc Activated Formula237 mL in 1 BOTTLELIQUID237 mL500 mg in 20mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-599SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.]2Unmatched20241215_c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4.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 54 of 87 · 1,721 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus-Clear Flu ReliefANAS BARBARIAE, ARSENICUM ALB, BAPTISIA, ECHINACEA PURP, GELSEMIUM, INFLUENZINUM, PHYTOLACCA, SARCOLACTICUM AC, SULPHUR, ZINC ACET, ZINC MUR, ZINC OXYSilver Star Brandsc442a928-4745-40d9-e053-2a95a90ad36c2025-01-01WarningsExact identifier
unii: 86Q357L16B
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
unii: PDC6A3C0OX
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
unii: PDC6A3C0OX
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
unii: LKG8494WBH
DG Health Sterile Saline MistSODIUM CHLORIDEDG Healthf2e44ab4-ae0f-c87b-e053-2a95a90acd042024-12-31WarningsExact identifier
unii: 451W47IQ8X
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
unii: V5VD430YW9
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: 451W47IQ8X
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
unii: PDC6A3C0OX
TREE ANTIGENPOPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLENatural Creations, Inc8040ab36-90eb-4076-a478-9b82ccfa4ec92024-12-23WarningsExact identifier
unii: 451W47IQ8X
Sterile Hypertonic Saline Solution 7 Sodium ChlorideSODIUM CHLORIDEJOONEM LLCe7110525-9f9b-5b68-e053-2995a90ac0342024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC49309411-9af4-4f19-a3bf-dbeabc1068272024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLCba0868f6-d3de-40e2-bcb3-144fa53062c72024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC9d83f477-ebbc-4248-8445-769178181d4f2024-12-23WarningsExact identifier
unii: 451W47IQ8X
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
unii: PDC6A3C0OX
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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