FDA.reportPublic FDA data

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 181 of 187 · 3,734 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CO COOLMENTHOL, PEPPERMINT OIL, PINUS PUMILIO BRANCH/LEAF OILLydia Co., Ltd.90b213fe-f7b9-555c-e053-2a95a90a1df32021-06-27WarningsExact identifier
unii: L7T10EIP3A
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC4a655cde-283f-4ec8-a3d9-5f539c55c2042021-05-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCed8fd0c1-ac42-4267-877e-ceadf3831c902021-04-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: 451W47IQ8X
Dr. Talbots Infant Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLCc0963200-67dd-6349-e053-2a95a90adde12021-04-22WarningsExact identifier
unii: 451W47IQ8X
D.PRO Pack SolidSODIUM CHLORITEPure O2c0289ea3-c592-0760-e053-2a95a90a0cfd2021-04-17WarningsExact identifier
unii: G538EBV4VF
DEFENDERSTICKSODIUM CHLORITEPure O2c02915ef-e7fc-4811-e053-2a95a90a97702021-04-17WarningsExact identifier
unii: G538EBV4VF
DEFENDER SIGNATURESODIUM CHLORITEPure O2c029345a-d44b-74db-e053-2995a90a1dbe2021-04-17WarningsExact identifier
unii: G538EBV4VF
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMedical Purchasing Solutions, LLCc3f8e83c-4fb9-91da-e053-2a95a90abd632021-04-12Adverse reactionsExact identifier
unii: 451W47IQ8X
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c69eaaf5-b8d4-708b-e053-2a95a90ae6d12021-03-15WarningsExact identifier
unii: V5VD430YW9
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c69f4926-c5c9-63a0-e053-2a95a90a2ca62021-03-15WarningsExact identifier
unii: V5VD430YW9
CVS Health Sterile Saline Mist Live BetterSODIUM CHLORIDECVS Pharmacyccc3ab8c-b22f-420d-869b-f2a65b8c71802021-03-13WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationaeaed9cb-b629-4019-88d2-a916179427de2021-02-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GUNA HEALTHY BRAINCITRULLUS COLOCYNTHIS FRUIT PULP - UBIDECARENONE - SUS SCRIFA ADRENAL GLAND - SUS SCROFA PLACENTA - SELENIUM - THUJA OCCIDENTALIS LEAFY TWIG - CONIUM MACULATUM FLOWERING TOP - SUS SCROFA EMBRYO - ACONITUM NAPELLUS - ALOE - BARIUM OXALOSUCCINATE - SUS SCROFA CEREBRUM - ARNICA MONTANA - SUS SCROFA HYPOTHALAMUS -Guna spaba486fa9-53d1-95d9-e053-2995a90af42d2021-02-17WarningsExact identifier
unii: V5VD430YW9
GUNA KIDNEY PLUSCALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -Guna spab8dacd94-8da1-4a8d-e053-2995a90acb672021-02-04WarningsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRUM MURIATICUMTrue Botanica, LLCb30b2880-28a1-47bd-83e7-da885a7c6f772021-01-24WarningsExact identifier
unii: 451W47IQ8X
Met-ToxARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODESwHITE mANUFACTURING INC DBA MICRO-WESTe65db4c2-0bc7-4c50-8f18-b36ee004c4f52021-01-21WarningsExact identifier
unii: 9NEZ333N27
unii: 451W47IQ8X
HPZECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCCWhite Manufacturing Inc. DBA Micro-Westdfbb5a35-8dfe-48f4-9177-6cb52fb440902021-01-21WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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