FDA.reportPublic FDA data

NDC 76357-491 - 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
76357-491
Manufacturer
Triumph Pharmaceuticals Inc.
Effective date
2023-12-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SmartMouth Mouth Sore Solution 1 - Triumph Pharmaceuticals Inc.Triumph Pharmaceuticals Inc.2023-12-21HUMAN OTC DRUG LABEL

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 178 of 183 · 3,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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 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
Flora PlusALOE, ALUMINA, ANTIMON CRUD, ARG NIT, CHELIDONIUM MAJ, GAMBOGIA, GRAPHITES, HYDRASTIS, LYCOPODIUM, SILICEANET Remediesfc1ced48-bd9f-4b3f-b786-573fba0729752021-01-21WarningsExact identifier
unii: ZY81Z83H0X
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
Day and Night VitalsALLIUM SAT, ALOE, ARSENICUM ALB, BERBER VULG, CALC PHOS, CEANOTHUS, CHELIDONIUM MAJ, CHOLESTERINUM, CLEMATIS ERECTA, CONDURANGO, GAMBOGIA, HAMAMELIS, KALI BROM, KALI PHOS, LYCOPODIUM, NAT CARB, PASSIFLORA, SENNA, SILICEA, SOLIDAGO, SPIGELIA ANTH, SPONGIA, VERATRUM VIRNET Remediesd5ddba51-5f0c-4b06-8f87-3cd6faf64b792021-01-19WarningsExact identifier
unii: ZY81Z83H0X
MetalALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIANET Remediesf7682a4e-c767-4429-98aa-e8c5ef6560a62021-01-19WarningsExact identifier
unii: 451W47IQ8X
3% Sodium Chloride3% SODIUM CHLORIDEBecton Dickinson and Companya8058593-48af-457a-b0f0-166935c7d10c2021-01-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEAsclemed USA, Inc.a411c118-ef0e-4c42-9924-4a06ec690e942021-01-14Adverse reactionsExact identifier
unii: 451W47IQ8X
Real ReliefAPIS MELLIFICA, ARNICA MONTANA, BENZOICUM ACIDUM, CAUSTICUM, COLCHICUM AUTUMNALE, NATRUM CARBONICUMGMP Laboratories of America, Inc.b7a1ce34-a996-22cf-e053-2a95a90afa452020-12-29WarningsExact identifier
unii: 8SKN0B0MIM
Sciatica-Back CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.99ea75a9-3250-281b-e053-2a95a90aed452020-12-07WarningsExact identifier
unii: 8SKN0B0MIM
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.99eda7db-ce40-446f-e053-2995a90a95aa2020-12-07WarningsExact identifier
unii: 8SKN0B0MIM

Reported adverse events (FAERS/openFDA)#

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