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 35 of 189 · 3,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sodium chlorideSODIUM CHLORIDEMedefil, Inc.d1468c0f-dd4f-4d38-a84c-c1d1103039652026-02-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
ResentmentADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f42e08d9-349e-4e53-802c-175cf17f3f2c2026-02-26WarningsExact identifier
unii: 451W47IQ8X
Advanced Pain Relief Cream With 5 % Natural MentholMENTHOLAllure Labs4bab9c43-86d4-dad2-e063-6394a90ac0952026-02-25WarningsExact identifier
unii: L7T10EIP3A
Walgreens Pain Relieving PatchMENTHOL, CAMPHOR, METHYL SALICYLATEWalgreen Co.4223c74a-12fb-51a3-e063-6294a90a0deb2026-02-25WarningsExact identifier
unii: L7T10EIP3A
Advanced Pain Relief Roll-On Gel With 5% Natural MentholMENTHOLAllure Labs4bad597f-acb2-a122-e063-6394a90a9fcf2026-02-25WarningsExact identifier
unii: L7T10EIP3A
Anti-Itch Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, AND SODIUM CHLORIDEForces of Nature6131d921-c772-4684-b9ea-c5c8923daaf02026-02-25WarningsExact identifier
unii: 451W47IQ8X
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLBetter Living Brands, LLCc2c6a591-c2fd-47ac-bf80-41e6030fdd752026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Rinse Spring MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Inc974e97c5-a255-4bb4-9ec9-5edc3f7899eb2026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFamily Dollar Stores, Inc1b50b865-3dfc-4b3f-86d5-5e91ca7724452026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Inc7a581e30-b062-498c-aefa-8fad58517afc2026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Inc7b6563bc-8aa7-48ea-bf1c-5d5a5ee2d3812026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Incc74250c1-785e-49da-9e53-88007bdfdaf52026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLH E Bf1450866-1be4-46d9-9fe4-52d699636b4f2026-02-24Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
unii: L7T10EIP3A
Family Wellness SF Honey Lemon Cough DropsMENTHOLFamily Dollar4437853d-1f42-a41d-e063-6294a90aa81e2026-02-24WarningsExact identifier
unii: L7T10EIP3A
dermaFIT Muscle Retention Cream StrengthMENTHOLEX Healthcare Inc.4620c41a-2187-00f5-e063-6394a90a613c2026-02-23WarningsExact identifier
unii: L7T10EIP3A
dermaFIT Muscle Retention Cream SculptMENTHOLEX Healthcare Inc.4620d4ca-42e4-eeae-e063-6394a90a5c842026-02-23WarningsExact identifier
unii: L7T10EIP3A
dermaFIT Muscle Retention Cream Extra StrengthMENTHOLEX Healthcare Inc.4620ca7a-afe6-d063-e063-6394a90ab5db2026-02-23WarningsExact identifier
unii: L7T10EIP3A
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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