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 19 of 192 · 3,838 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
unii: L7T10EIP3A
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
unii: L7T10EIP3A
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
unii: L7T10EIP3A
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
unii: L7T10EIP3A
Plantar Pain Relief PatchLIDOCAINE AND MENTHOLGuangzhou Sumi Technology Innovation Co., Ltd4e8734db-e474-e1fa-e063-6394a90a30292026-05-14WarningsExact identifier
unii: L7T10EIP3A
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
unii: L7T10EIP3A
Pain ReliefLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.3ed51136-ea8e-8101-e063-6394a90acd4c2026-05-14WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.4fdae0ab-94ba-5707-e063-6294a90a1f9d2026-05-14WarningsExact identifier
unii: L7T10EIP3A
OVERNIGHT RELIEF Gel-PatchMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.2c6c4737-dff3-6382-e063-6294a90a412c2026-05-14WarningsExact identifier
unii: L7T10EIP3A
Pain ReliefMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.3ed34e65-9d74-daff-e063-6394a90a94c72026-05-14WarningsExact identifier
unii: L7T10EIP3A
MENTHOL PAIN RELIEF Gel-PatchMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.0e6a09cc-7986-f851-e063-6294a90aff672026-05-14WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.3c166165-2ad8-206f-e063-6294a90a52fc2026-05-14WarningsExact identifier
unii: L7T10EIP3A
OVERNIGHT RELIEF Gel-PatchMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f1041b25-eb09-e43d-e053-2995a90a073a2026-05-14WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f1047707-3fe5-06bc-e053-2995a90a59b92026-05-14WarningsExact identifier
unii: L7T10EIP3A
Elastic Relief StripMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f103cf8a-a285-28d1-e053-2995a90ae70e2026-05-14WarningsExact identifier
unii: L7T10EIP3A
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
Halls Honey LemonMENTHOLMondelez Global LLCaec46410-ffb1-4db4-b232-82110c562f692026-05-13WarningsExact identifier
unii: L7T10EIP3A
Pain Relief Gel-Roll OnMENTHOLTrifecta Pharmaceuticals USA51b403dc-fc9b-0cad-e063-6394a90af0812026-05-13WarningsExact identifier
unii: L7T10EIP3A
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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