FDA.reportPublic FDA data

NDC 76357-491 - 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
76357-491
Manufacturer
Triumph Pharmaceuticals Inc.
Effective date
2023-12-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SmartMouth Mouth Sore Solution 1 - Triumph Pharmaceuticals Inc.Triumph Pharmaceuticals Inc.2023-12-21HUMAN OTC DRUG LABEL

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 102 of 189 · 3,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dairy-Grain-NightshadeIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.99fcbd61-ecc8-cf9d-e053-2995a90aebeb2025-07-25WarningsExact identifier
unii: 451W47IQ8X
BedwettingECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUSNewton Laboratories, Inc.9d5f51d0-01e9-271c-e053-2995a90a63bc2025-07-24WarningsExact identifier
unii: 451W47IQ8X
BedwettingECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUSNewton Laboratories, Inc.9d6058a0-69dd-66d0-e053-2a95a90a58f82025-07-24WarningsExact identifier
unii: 451W47IQ8X
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: 451W47IQ8X
Cannarelief 2000mgMENTHOLEarthmed LLC01f810de-52ba-8beb-e063-6394a90a61c02025-07-24WarningsExact identifier
unii: L7T10EIP3A
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: 451W47IQ8X
CHING WAN HUNG SOOTHING HERBAL BALMMENTHOLTIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD.ffadc904-8e9d-4cb8-815a-d583bbdb3f0b2025-07-24WarningsExact identifier
unii: L7T10EIP3A
PT Elite Premium Pain ReliefCAPSAICIN, MENTHOLPT ELITE PRODUCTS LLCad251821-4c58-425d-bdcb-8dd9bd41b7132025-07-23WarningsExact identifier
unii: L7T10EIP3A
Game On XtremeMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.5a1b6192-d537-42b3-add8-22c63e7c986c2025-07-23WarningsExact identifier
unii: L7T10EIP3A
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Rheumatic-Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.9cae6bd9-5427-4482-e053-2a95a90a7a762025-07-23WarningsExact identifier
unii: 8SKN0B0MIM
DetoxifierCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS,CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, NUX VOMICA, URICUM ACIDUM.Newton Laboratories, Inc.9d720ba6-294f-4c9b-e053-2a95a90ac2d92025-07-23WarningsExact identifier
unii: 8SKN0B0MIM
Sodium ChlorideSODIUM CHLORIDENextgen Pharmaceuticals LLC28f79c75-82d2-4912-81fc-a723b5ccf4c12025-07-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AMRUTANJAN RELIEF PAIN BALMCAMPHOR , MENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITEDddee6714-8b18-4d87-944b-8467fda22e6b2025-07-23WarningsExact identifier
unii: L7T10EIP3A
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.8bb89002-d7a2-4bee-b5a5-1fd1949273ef2025-07-22WarningsExact identifier
unii: L7T10EIP3A
Hielo ArdienteMENTHOLMenper Distributors, Inc.97ec516c-d2bc-47ce-82fe-bd68445d95702025-07-22WarningsExact identifier
unii: L7T10EIP3A
DetoxifierCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS,CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, NUX VOMICA, URICUM ACIDUM.Newton Laboratories, Inc.9d72d9ec-c7c3-7b45-e053-2a95a90afe962025-07-22WarningsExact identifier
unii: 8SKN0B0MIM
Viva Porru Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMenper Distributors, Inc.0dfadfe3-9e40-0eee-e063-6294a90a00c32025-07-22WarningsExact identifier
unii: L7T10EIP3A
AMRUTANJAN RELIEF STRONG PAIN BALMMENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITED206d8c1e-eb5b-4ec7-a54e-8defc9fb9d272025-07-22WarningsExact identifier
unii: L7T10EIP3A
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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