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 142 of 189 · 3,765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f515f-7302-d153-e053-6394a90a08342024-10-08WarningsExact identifier
unii: L7T10EIP3A
Vamousse Lice DefenseEUCALYPTUS GLOBULUS, NATRUM MURIATICUMAlliance Pharma Inc.c87ce5d3-c200-421e-88be-bc8060a5993a2024-10-08WarningsExact identifier
unii: 451W47IQ8X
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharma, PTda338796-de9c-be51-e053-2a95a90a25092024-10-07WarningsExact identifier
unii: L7T10EIP3A
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharmae2c5f821-cdd5-190d-e053-2a95a90a91592024-10-07WarningsExact identifier
unii: L7T10EIP3A
Severe Throat Sore DropsMENTHOLTarget Corporation Inc.949543d5-5043-ac06-e053-2995a90ab3982024-10-07WarningsExact identifier
unii: L7T10EIP3A
Natural Herbal Cough DropsCOUGH DROPSTarget Corporation Inc.a23ddfa9-19e0-99ee-e053-2a95a90a68562024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsSIMPLY MENTHOL COUGH DROPSPerrigo Direct, Inc.fb809c63-94f1-bb7a-e053-6294a90a0a392024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsSIMPLY CHERRY COUGH DROPSPerrigo Direct, Inc.fb808dc5-bf63-836c-e053-6294a90a80aa2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsSIMPLY HONEY LEMONPerrigo Direct Inc.fb898616-d604-b4c3-e053-6294a90a23bf2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Natural Herb Cough DropsMENTHOL HERBCVS Pharmacyfcd16063-abca-49a0-e053-6294a90acb262024-10-07WarningsExact identifier
unii: L7T10EIP3A
Lemon Mint Herb Throat DropsSUGAR FREE LEMON MINT HERBCVS Pharmacyfce6b5fa-846d-9911-e053-6294a90afc9b2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cough DropsMENTHOLCVS Pharmacyfcd053e9-92ef-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyf074a64d-dc01-1a37-e053-2995a90adc492024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsHONEY LEMONCVS Pharmacyf075010d-a07a-5e9d-e053-2995a90a3ca32024-10-07WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyfcd053e9-92ee-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
unii: L7T10EIP3A
NanoXtreme Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLCc1490c30-a9db-4120-adaf-9e8000169e462024-10-07WarningsExact identifier
unii: L7T10EIP3A
Black Cherry Cough DropsMENTHOLBoston Nutraceutical Production SL856f2e1a-2593-99e6-e053-2991aa0ad0392024-10-07WarningsExact identifier
unii: L7T10EIP3A
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857363b6-e025-e074-e053-2a91aa0a43792024-10-07WarningsExact identifier
unii: L7T10EIP3A
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857365ba-895e-4a63-e053-2991aa0a8b9f2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Menthol Vapor Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La7062db1-8201-b400-e053-2a95a90a55e82024-10-07WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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