FDA.reportPublic FDA data

NDC 76357-489 - 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
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 92 of 192 · 3,838 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KALAYA BACK AND NECK PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp48fd73e7-1443-4ac7-bf7c-d99bf2449f512025-10-08WarningsExact identifier
unii: L7T10EIP3A
Equate RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalmart Inc01e1f418-c232-e89e-e063-6294a90abd352025-10-08WarningsExact identifier
unii: L7T10EIP3A
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 451W47IQ8X
Equate Pain Relief BalmMENTHOL 11%, CAMPHOR 11% OINTMENTWALMART, INCd8ddf835-f008-ce1f-e053-2a95a90aa9b32025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Dollar General Assorted Flavors 80ctMENTHOLDollar General425d2e63-f5bc-45fb-b330-967ae64cfddb2025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporationb96268da-d6f2-41e4-ba04-ce419376f6262025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporation8f8a9474-f388-4ede-85f2-86222b15ee582025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporation61a23ce6-5157-4076-afa7-6a79c62fe9e02025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation9f9916f5-83ea-4f36-b8c2-c6fe1f77884b2025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporationfbe92e39-6470-4634-b976-e316baa2c9952025-10-08WarningsExact identifier
unii: L7T10EIP3A
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporation0ea61a4c-690a-4349-9952-cc17fb1f06712025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporation773f4ad2-6c91-431f-ad3d-c0e53e7ca9182025-10-08WarningsExact identifier
unii: L7T10EIP3A
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 451W47IQ8X
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporation13c7d3b1-12ac-4931-877c-728d3d89942c2025-10-08WarningsExact identifier
unii: L7T10EIP3A
TheraCare Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare9d2ccb02-746c-4cb9-905d-280987778f4d2025-10-08WarningsExact identifier
unii: L7T10EIP3A
Cough Drops Freegells Strawberry 30ctMENTHOLR.L. ALBERT & SON, INCdc077c36-c403-4b83-894a-e9922e9288412025-10-08WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol Cherry 200ctMENTHOLR.L. ALBERT & SON, INCf62b7f75-3275-46c9-880c-64148d0dce592025-10-08WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol 80ctMENTHOLR.L. ALBERT & SON, INC15917bfb-f660-4a12-bdcc-5b4a96e0e1d02025-10-08WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol Cherry 30ctMENTHOLR.L. ALBERT & SON, INCbac77712-6197-4b30-a5f8-9b99eb9d7b5a2025-10-08WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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