FDA.reportPublic FDA data

NDC 76357-489 - SmartMouth Mouthwash SmartMouth Mouth Sore 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
76357-489
Package NDCs from labels
76357-489-02
Manufacturer
Triumph Pharmaceuticals, Inc.
Effective date
2024-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SmartMouth™ Mouthwash Mouth Sore Solution 1Triumph Pharmaceuticals, Inc.2024-12-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-489-02SmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula237 mL in 1 BOTTLELIQUID237 mL10 mg in 20mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-489SMARTMOUTH MOUTHWASH SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS, INC.]1Unmatched20250101_f1e5f1e0-ad3f-4bc6-a2ca-5ec71f081815.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 169 of 186 · 3,719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
unii: L7T10EIP3A
EXOTEN-CMETHYL SALICYLATE, MENTHOL, CAPSAICINAsclemed USA, Inc.76ed37e0-64b5-4abe-a03c-3dc7084a39192023-10-16WarningsExact identifier
unii: L7T10EIP3A
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Incbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b62023-10-16WarningsExact identifier
unii: L7T10EIP3A
Calypxo HP Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Inc89a8c267-bd92-4d0d-8e50-c52224aff9cd2023-10-16WarningsExact identifier
unii: L7T10EIP3A
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
unii: L7T10EIP3A
Eyeganics Organic TearsGLYCERINEyeganics LLC42470af7-a3ae-4e14-88e0-04cd92db4b372023-10-13WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal Pain Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
unii: PDC6A3C0OX
Bio Detox FormulaEUCALYPTUS GLOBULUS, ALOE, HYDRASTIS CANADENSIS, ALLIUM SATIVUM, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, BACILLUS TETANI, PNEUMOCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, STAPHYSAGRIA, EUCALYPTOL, PYROGENIUM, LAC CANINUM, LAC VACCINUM, PESTINUMNutritional Specialties, Inc.a4644c7a-fa08-4a43-909a-13b2be773e4e2023-10-09WarningsExact identifier
unii: V5VD430YW9
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
Diarrhea FormulaCINCHONA OFFICINALIS, RHEUM (PALMATUM), PODOPHYLLUM PELTATUM, IPECACUANHA, ALOE, COLOCYNTHIS, ARSENICUM ALBUM, TEREBINTHINA, VERATRUM ALBUM, ANTIMONIUM CRUDUM, MERCURIUS CORROSIVUSNutritional Specialties, Inc.9390968d-6316-4f3f-a041-831275fd41352023-10-05WarningsExact identifier
unii: V5VD430YW9
Zincum MuriaticumZINCUM MURIATICUMHahnemann Laboratories, INC.06ecda16-b4b2-1b9e-e063-6294a90a48912023-10-04Exact identifier
unii: 86Q357L16B
Uric Acid BalancerDULCAMARA, LEDUM PALUSTRE, ARNICA MONTANA, BENZOICUM ACIDUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, LITHIUM CARBONICUM, NATRUM PHOSPHORICUM, URTICA URENS, FORMICA RUFA, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f46c8203-4022-4240-bb45-2a3a8a318eae2023-10-04WarningsExact identifier
unii: 8SKN0B0MIM
Cough DropsMENTHOLTopco Associates LLC06d2c6cf-0adb-91b9-e063-6294a90aff522023-10-03WarningsExact identifier
unii: L7T10EIP3A
WHITE FLOWER STRAIN RELIEFCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD65282267-de63-453a-a686-f8752c71b9ef2023-10-02WarningsExact identifier
unii: L7T10EIP3A
WHITE FLOWER ANALGESIC BALM FLORAL SCENTEDCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD4e9cb5aa-b0aa-4a5c-b561-cc38437758d82023-10-02WarningsExact identifier
unii: L7T10EIP3A
PhysiolyteSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e2023-09-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: 451W47IQ8X
CardCareECHINACEA, HYPERICUM, VALERIANA, ACONITUM NAP., ARSENICUM ALB., AUR. MET., BARYTA CARB., BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. FLUOR., CANTHARIS, CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, CONVALLARIA, CROTALUS HOR., DIGITALIS, GELSEMIUM, GLONOINUM, HYDROFLUORICUM AC. KALI IOD., LACHESIS, LYCOPUS, NAJA, NUX VOM., PHOS., PULSATILLA, RHUS TOX., VIPERA, ELAPS.Newton Laboratories, Inc.06342201-f0b4-de0d-e063-6294a90a56212023-09-25WarningsExact identifier
unii: 8SKN0B0MIM
Epiforce P-HPARSENICUM ALBUM, BORAX, GRAPHITES, NATRUM MURIATICUM, SEPIA, SULPHURBioActive Nutritional, Inc.250441d1-e261-417e-9100-700368ea38fd2023-09-11WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.a9910e09-5aea-4ee1-a35e-ae4abf8b80b42023-09-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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