FDA.reportPublic FDA data

NDC 65517-2004-01 - DawnMist Gel Fluoride

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
65517-2004
Requested NDC
65517-2004-01
Package NDCs from labels
65517-2004-1, 65517-2004-0, 65517-2004-2, 65517-2004-3, 65517-2004-01
Manufacturer
Dukal LLC
Effective date
2025-02-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DawnMist Gel Fluoride - Dukal LLCDukal LLC2025-02-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2004-0DawnMist Gel Fluoride78 g in 1 TUBEGEL, DENTIFRICE783
65517-2004-1DawnMist Gel Fluoride17 g in 1 TUBEGEL, DENTIFRICE173
65517-2004-2DawnMist Gel Fluoride24 g in 1 TUBEGEL, DENTIFRICE243
65517-2004-3DawnMist Gel Fluoride43 g in 1 TUBEGEL, DENTIFRICE433

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2004DAWNMIST GEL FLUORIDE (GEL FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [DUKAL LLC]3Current NDC, 4 package rows20250210_14443184-1694-70b9-e063-6394a90a86fe.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 64 of 111 · 2,214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8264e849-a6b3-4953-a85b-da9d4e7f5a702025-09-02WarningsExact identifier
application number: M021
CAREKON ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEHunan Yinhuatang Pharmaceutical Technology Co., Ltd.3baca3b6-ff48-0579-e063-6394a90abd082025-08-29WarningsExact identifier
application number: M021
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multivitamin with FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLCa10ff759-eba7-414b-bb98-f17fbb6e6b572025-08-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
unii: ETJ7Z6XBU4
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: K679OBS311
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: K679OBS311
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Inc.0c3ed6fe-8dce-0496-e063-6394a90add562025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc.fc794fe5-7135-4b2b-b002-a75908223f202025-08-13WarningsExact identifier
application number: M021
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEAcuseplanet Inc3c04778b-9535-856e-e063-6294a90aa8682025-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEAcuseplanet Inc3c0e1862-293f-4d23-e063-6294a90a33e12025-08-10WarningsExact identifier
application number: M021
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
rxcui: 245598
unii: 8ZYQ1474W7
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
unii: 8ZYQ1474W7
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
unii: 8ZYQ1474W7
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: K679OBS311
Schuessler Tissue Salts Silica Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltdf70dcf90-bde9-404d-9ede-4113553ccbff2025-08-04WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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