NDC 76357-489-02 - 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
Requested NDC: 76357-489-02
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
Label	Manufacturer	Effective date	Type
SmartMouth™ Mouthwash Mouth Sore Solution 1	Triumph Pharmaceuticals, Inc.	2024-12-18	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76357-489-02	SmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula	237 mL in 1 BOTTLE	LIQUID	237 mL	10 mg in 20mL	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76357-489	SMARTMOUTH MOUTHWASH SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS, INC.]	1	Unmatched	20250101_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 180 of 187 · 3,734 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAIR STIM	PEDICULUS 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 MINOR	The Wellness Center for Research and Education, Inc.	d5c75dc2-9edc-429e-8f25-e5641fe5042f	2021-11-23	Warnings	Exact identifier unii: 451W47IQ8X
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	e4f06c0b-7cb1-49c9-97a4-2cfc21298495	2021-11-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
CONSTIPATION CP	ALUMINUM 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-b5e4-0fd8d9652edf	2021-11-15	Warnings	Exact identifier unii: 451W47IQ8X
CENTROCODE	AMERICAN 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-7047c10198b6	2021-11-15	Warnings	Exact identifier unii: 451W47IQ8X
OHM-ANX	ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, MOSCHUS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, STANNUM METALLICUM, VALERIANA OFFICINALIS	OHM PHARMA INC.	f743b690-8f79-4e60-81cd-e3e2825a1ec8	2021-11-15	Warnings	Exact identifier unii: 451W47IQ8X
Hydrate 2	BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA	Natural Creations, Inc	52cb98dc-6858-42bf-9c54-d20fb607dfbb	2021-11-12	Warnings	Exact identifier unii: 451W47IQ8X
Adrenal and DHEA	ARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.	ProBLEN	44991952-c440-4a33-9423-a9369c8bab70	2021-10-22	Warnings	Exact identifier unii: 451W47IQ8X
Dr. Talbots Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC.	91c2795d-4cde-6e2c-e053-2995a90a0096	2021-10-05	Warnings	Exact identifier unii: 451W47IQ8X
Solucion InterSol	SOLUCION ADITIVA PARA PLAQUETAS 3	Fenwal, Inc.	d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1	2021-10-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ALOE SOCOTRINA	ALOE SOCOTRINA	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	9294683e-beaa-4c58-9b08-9890f1b61e43	2021-09-29	Warnings	Exact identifier unii: V5VD430YW9
NATRUM MURIATICUM	NATRUM MURIATICUM	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	520edb18-5f2a-4448-ba53-83408a839e1f	2021-09-02	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Lactated Ringers Irrigation	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE	B. Braun Medical Inc.	0db56c7a-2b8f-4593-8591-2c481c92b2cf	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride for Irrigation	SODIUM CHLORIDE FOR IRRIGATION	B. Braun Medical Inc.	5bd9b176-0402-4a3f-a6b4-c3f393fc092a	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
SPORTS gel	MENTHOL	Aloe Vera Korea Co.,Ltd.	c84fc51c-0e2c-56a2-e053-2995a90a077e	2021-08-03	Warnings	Exact identifier unii: L7T10EIP3A
0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c755e41b-acba-7234-e053-2995a90aff0f	2021-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
UNDA 5	TORMENTILLA, TUSSILAGO FARFARA, ADIANTUM CAPILLUS-VENERIS, GLYCYRRHIZA GLABRA, DROSERA, GRINDELIA, INULA HELENIUM, CUPRUM METALLICUM, ARGENTUM METALLICUM	Seroyal USA	1789ed21-3bc9-3b86-e054-00144ff88e88	2021-07-15	Warnings	Exact identifier unii: V5VD430YW9
Melange combination	CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA	Seroyal USA	0a071fbf-0075-4479-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 451W47IQ8X
Hemorrhoids	ELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.	Newton Laboratories, Inc.	c6f30a27-ae7f-2574-e053-2995a90a9102	2021-07-12	Warnings	Exact identifier unii: V5VD430YW9

Reported adverse events (FAERS/openFDA)#

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