FDA.reportPublic FDA data

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
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 123 of 189 · 3,765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
unii: L7T10EIP3A
Sulfur anti-mite shower gelSODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.Guangdong Junhui Biotechnology Co., Ltd251ee057-1adf-bc97-e063-6394a90acdd32025-01-08WarningsExact identifier
unii: 9NEZ333N27
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
unii: L7T10EIP3A
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 8SKN0B0MIM
unii: LKG8494WBH
unii: 506T60A25R
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEGERI-GENTLE CORPORATIONe673d8bd-2573-9f04-e053-2995a90a172a2025-01-06WarningsExact identifier
unii: L7T10EIP3A
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
unii: L7T10EIP3A
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: 451W47IQ8X
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Sweat-LessARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MURSilver Star Brands4053d10b-4b06-291b-e054-00144ff88e882025-01-01WarningsExact identifier
unii: 451W47IQ8X
Arthritis EaseARNICA, BENZOICUM AC, BRYONIA, CALC PHOS, COLCHIUM, RHUS TOX, RUTASilver Star Brandsc68b587f-14eb-395a-e053-2a95a90ae8012025-01-01WarningsExact identifier
unii: 8SKN0B0MIM
NativeRemedies Triple Complex Brain TonicCALC PHOS, KALI PHOS, NAT MUR.Silver Star Brandsf76eaf46-4a80-31a9-e053-6394a90a542d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: 8SKN0B0MIM
Headache EaseAUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIASilver Star Brandsc689fb16-6200-ac94-e053-2995a90a703d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: 451W47IQ8X
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
Green Compass Reduce Pain Relief with MentholMENTHOLGreen Compass, Inc.0a0c212e-ae5d-8505-e063-6394a90af6222025-01-01WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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