FDA.reportPublic FDA data

NDC 76357-599 - SmartMouth SmartMouth Gum Health 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
76357-599
Package NDCs from labels
76357-599-02
Manufacturer
Triumph Pharmaceuticals, Inc.
Effective date
2024-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SmartMouth Gum Health Solution 1 - Triumph Pharmaceuticals, Inc.Triumph Pharmaceuticals, Inc.2024-12-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-599-02SmartMouth SmartMouth Gum Health Zinc Activated Formula237 mL in 1 BOTTLELIQUID237 mL500 mg in 20mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-599SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.]2Unmatched20241215_c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4.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 88 · 1,741 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Anal Care GLO packCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.26612dae-21a0-6f12-e063-6394a90afe932026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, Proctalgia Relief WashCARBON, PANTHENOL, SODIUM HYALURONATEWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1e20de39-45b0-54ec-e063-6294a90a04ed2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, Proctalgia OintmentsCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERINWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1efe43d5-a29b-5cb2-e063-6394a90aca662026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: 451W47IQ8X
LuffaLUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTAMarco Pharma International LLC.7dbb79de-c3f5-4245-884a-a6bd29bb861c2026-01-12WarningsExact identifier
unii: 451W47IQ8X
LymphonestECHINACEA AUGUSTIFOLIA, SCROPHULARIA NODOSA, ABROTANUM, PETROLEUM, ALOE SOCOTRINA, MERCURIUS SOLUBILIS, CROTALUS HORIIDUS, THUJA OCCIDENTALIS, LACHESIS MUTUS, ARISTOLOCHIA CLEMATITISMarco Pharma International LLC.84e18e97-4892-4699-b0c6-c194dc783b2d2026-01-12WarningsExact identifier
unii: V5VD430YW9
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
unii: PDC6A3C0OX
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Renal Drops 5024RENAL DROPSProfessional Complementary Health Formulase598ae46-3b14-4dce-b7e0-abf159d102db2026-01-08WarningsExact identifier
unii: 8SKN0B0MIM
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 451W47IQ8X
Normal Intestinal Flora Nosode Combination 9412NORMAL INTESTINAL FLORA NOSODE COMBINATIONProfessional Complementary Health Formulasaf758440-624f-4844-9477-2eda7131ae072026-01-08WarningsExact identifier
unii: V5VD430YW9
Veratrum Combination 9250VERATRUM COMBINATIONProfessional Complementary Health Formulas63597f2a-22c1-41c2-b461-3517447cc03e2026-01-08WarningsExact identifier
unii: V5VD430YW9
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cranial Sacral Drops 5003CRANIAL SACRAL DROPSProfessional Complementary Health Formulasbb655e0a-f735-4bec-9903-d98ba09cebf72026-01-08WarningsExact identifier
unii: V5VD430YW9
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 451W47IQ8X
Viral Immune Stimulator 6017VIRAL IMMUNE STIMULATORProfessional Complementary Health Formulasf462cfb7-e1c3-4ded-9f79-f1983517fe152026-01-08WarningsExact identifier
unii: 451W47IQ8X
Rhododendron Combination 9241RHODODENDRON COMBINATIONProfessional Complementary Health Formulas9a3d93c9-261d-4711-ad75-8e4c1f87c9362026-01-08WarningsExact identifier
unii: 8SKN0B0MIM
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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