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 170 of 189 · 3,765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
unii: L7T10EIP3A
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: PDC6A3C0OX
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: PDC6A3C0OX
DG Health Cough Drops Cherry FlavorMENTHOLDollar General Corporationc7a603d8-72fb-9626-e053-2995a90a09ea2023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol CherryMENTHOLRiclan S.A.8e471265-3594-451a-8921-f0db474abe852023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol EucalyptusMENTHOLRiclan S.A.1141593a-f3ba-4adf-b332-f9fcb0b5a0132023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol Honey LemonMENTHOLRiclan S.A.f6271e85-9ca2-41d3-9bff-a13670ac5b802023-10-26WarningsExact identifier
unii: L7T10EIP3A
Freegells Cough Drops Menthol StrawberryMENTHOLRiclan S.A.da2bbc92-7d96-4f3e-89e2-c2a9e3e4b4572023-10-26WarningsExact identifier
unii: L7T10EIP3A
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
unii: L7T10EIP3A
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: PDC6A3C0OX
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.c8d4ae28-efc4-6a00-e053-2a95a90a40bf2023-10-25WarningsExact identifier
unii: L7T10EIP3A
Cryo10 Topical AnalgesicMENTHOLElement 26 LLCff1d2140-9302-918c-e053-6394a90acb9a2023-10-25WarningsExact identifier
unii: L7T10EIP3A
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
unii: L7T10EIP3A
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
XtraCare Ice Cold Topical Analgesic GelMENTHOLRejoice Internationald38f3099-d940-44d8-aa7f-404157c5e0e32023-10-24WarningsExact identifier
unii: L7T10EIP3A
TheraPlus PlusMENTHOLZhejiang Jingwei Pharmaceutical Co., Ltd.d4119f84-eb60-4134-b58e-de13d96011992023-10-24WarningsExact identifier
unii: L7T10EIP3A
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
unii: PDC6A3C0OX
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
NUMOTIZINEMENTHOLHobart Laboratories, Inc.9a29ad1b-4ba3-403f-90c9-ee7582fe45352023-10-20WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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