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 41 of 192 · 3,838 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHarris Teeter9fb0fa91-282a-440d-9d1d-c868a5978ee32026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHARRIS TEETER98728688-32f6-44f1-9cc9-cd72c3a039ad2026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLHy-Vee, Inc.446de381-6685-748d-e063-6394a90a1b732026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHy-Vee, Inc.4538029b-1ff9-080a-e063-6394a90ac9b72026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLLidl US, LLCc3bd0ca6-3f42-423b-92ac-c7f8fc09152b2026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLMarc Glassman, Inc47339eeb-8097-498a-ba4e-a73de477aa182026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMarc Glassman, Ince668364b-907b-48fc-9fb2-97619607506b2026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMarc Glassman, Incf0ac9715-7d9f-48e9-9371-bb7d8be29c662026-02-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4a065965-43bd-e0e3-e063-6294a90ad76a2026-02-04WarningsExact identifier
unii: L7T10EIP3A
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a0969d3-1f06-3ba7-e063-6294a90a86272026-02-04WarningsExact identifier
unii: L7T10EIP3A
0.9 percentsalineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd487cb4fc-2e0b-020f-e063-6294a90a45262026-02-03WarningsExact identifier
unii: 451W47IQ8X
Relief FlexMENTHOLBeone Co., Ltd.49e6f0ef-78fb-26fe-e063-6294a90a66552026-02-03WarningsExact identifier
unii: L7T10EIP3A
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.204025ac-af00-48a0-be8e-7ccc7a36ad452026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.3fceecc1-22b4-43a5-a4e0-d7d5634bcf812026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.60d8a79c-82a4-4312-b7c8-519e2000bc8e2026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Foster and Thrive Cherry Cough DropsMENTHOLMcKesson49eefa70-cef9-d7ec-e063-6294a90ac3212026-02-03WarningsExact identifier
unii: L7T10EIP3A
Eucalyptol, menthol, methyl salicylate, thymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDemoulas Super Markets, Inc51748426-047a-4ecf-b0fe-205667c9ef082026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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