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 83 of 109 · 2,164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clinpro 5000SODIUM FLUORIDESolventum US LLCa20d3cf0-2e1f-4191-971e-9e47936b45802024-08-01Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum FlavorSODIUM FLUORIDEAshtel Studios Inc.bbf6cfe7-c5e5-4e63-ac7d-4535a0ca39732024-07-31WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios Inc.32780fe9-82bf-42f8-8218-bed5bc579c722024-07-30WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.7ba8cff2-92a4-4432-aaf3-50358d9483a22024-07-30WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios Inc.ed057c95-90cd-4edb-ac00-78db8f6a065b2024-07-29WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.f01c5eaf-7e81-4b30-bb6f-50566a7273642024-07-29WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsExact identifier
unii: 8ZYQ1474W7
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium MonofluorophosphateWHITE TOOTHPASTEDynarex Corporation1be422b9-6320-ed5c-e063-6294a90a7e422024-07-03WarningsExact identifier
application number: M021
Wpgcng Antiacvity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.5756206e-43cc-8cc7-e063-6394a90a29502024-07-03WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
dentalux SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE, SODIUM FLUORIDELidl US, LLCbaef7f15-8082-4e61-8c08-8beda8ad40c02024-07-03WarningsExact identifier
unii: 8ZYQ1474W7
dentalux Kids ANTI-CAVITY FLUORIDE Bubble GumSODIUM FLUORIDELidl US, LLC0c77ba33-acb9-4c83-aa75-7d5c82f903eb2024-07-02WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
dentalux ANTI-CAVITY FLUORIDE WHITENING MINTSODIUM FLUORIDELidl US, LLC37011052-16ef-4ae4-aade-a86f9fa9cdac2024-07-02WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
dentalux ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATELidl US, LLCccf54743-81c2-43f8-9c5c-d4baa85fc18d2024-07-02WarningsExact identifier
application number: M021
SmileSenseSTANNOUS FLUORIDESGII, INC1c371393-da75-c9c8-e063-6294a90a58402024-07-01WarningsExact identifier
application number: M021
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium FluorideCLEAR MINT, GEL TOOTHPASTEDynarex Corporation1be193b6-4c07-4f0a-e063-6394a90a32c72024-06-27WarningsExact identifier
application number: M021
rxcui: 245598
unii: 8ZYQ1474W7
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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