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 62 of 192 · 3,838 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amazon Basics Cold and Hot Medicated PatchMENTHOLAmazon.com Services LLCe3b4db12-c846-b984-e053-2a95a90a8e9a2025-12-28WarningsExact identifier
unii: L7T10EIP3A
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Absorbine Jr Neck and ShoulderABSORBINE JR NECK AND SHOULDERClarion Brands LLC22f2f191-9146-3075-e063-6394a90aef5f2025-12-28WarningsExact identifier
unii: L7T10EIP3A
Absorbine Jr. Pain Relieving Knee PatchABSORBINE JR. PAIN RELIEVING KNEE PATCHClarion Brands, LLC22f71254-e521-2d82-e063-6394a90a12d82025-12-28WarningsExact identifier
unii: L7T10EIP3A
Absorbine Jr Back PatchABSORBINE JR BACK PATCHClarion Brands LLC.22f5147e-ff2b-4ae8-e063-6394a90a4e542025-12-28WarningsExact identifier
unii: L7T10EIP3A
Med Rub BalmACHES AND PAIN BALMWellmetech Pharmaceutical Industries SDN BHDa5801566-6bbe-44f6-8761-9c1ce30969002025-12-27WarningsExact identifier
unii: L7T10EIP3A
N-Labs ArcticZen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNutriomo Labs PTE., LTD46e92db7-a48b-2c7a-e063-6394a90a438e2025-12-27WarningsExact identifier
unii: L7T10EIP3A
Absorbine Jr. PlusMENTHOLClarion Brands, LLC46f4ad3c-7418-a6bf-e063-6394a90a4eb82025-12-27WarningsExact identifier
unii: L7T10EIP3A
Equate Lidocaine Cool and HeatLIDOCAINE 4% PLUS MENTHOL 1%Walmart Stores Incb86769c3-a0b4-c481-e053-2a95a90af38b2025-12-27WarningsExact identifier
unii: L7T10EIP3A
Medicated Body Extra Strength PowderMENTHOL 0.80%Walmart Stores Incb0786418-7b28-d316-e053-2995a90a3ab52025-12-27WarningsExact identifier
unii: L7T10EIP3A
Maximum Strength Medicated Foot PowderMEDICATED FOOT POWDERWalmart Stores Incb0794d48-eb8b-55c9-e053-2995a90a5b382025-12-27WarningsExact identifier
unii: L7T10EIP3A
Arthritis Pain Relieving CreamMENTHOL, METHYL SALICYLATEInternational Nature Nutraceuticals, Inc.2c9d070c-bf90-4482-8a6e-c7491cdd34c52025-12-27WarningsExact identifier
unii: L7T10EIP3A
caring mill Cough drops CHERRYMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a28aa-00e9-8b9d-e063-6394a90ace2a2025-12-26WarningsExact identifier
unii: L7T10EIP3A
Creamy Strawberry Flavor Cough DropCREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749b83a-ea4f-d8ca-e063-6394a90a69b72025-12-26WarningsExact identifier
unii: L7T10EIP3A
DISCOUNT DRUG MARTCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f4a026-c4d2-2645-e063-6294a90aac582025-12-26WarningsExact identifier
unii: L7T10EIP3A
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a13b5-6fcb-70ed-e063-6394a90a7fb32025-12-26WarningsExact identifier
unii: L7T10EIP3A
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a4802-7c02-ccce-e063-6394a90ad71d2025-12-26WarningsExact identifier
unii: L7T10EIP3A
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749f353-9286-15b9-e063-6394a90a76932025-12-26WarningsExact identifier
unii: L7T10EIP3A
Leader Cough Drops Vanilla HoneyMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a93c2c-a663-e3d1-e063-6394a90ad8592025-12-26WarningsExact identifier
unii: L7T10EIP3A
Frankincense and Myrrh Foot Pain ReliefMENTHOLWISE CONSUMER PRODUCTS CO.115f1abc-34aa-3c20-e063-6294a90a97642025-12-26WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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