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 75 of 109 · 2,164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POP Gel Pumpin StrawberrySODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b1020b-a1c3-e1eb-e063-6394a90ac2662025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
PERIOE POP Complete Protection Prebiotic Mint BlastSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f547a468-d2fd-7176-e053-2995a90a55392025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
PERIOE Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.b4530d56-3a17-6868-e053-2995a90a25242025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
PERIOE Microbiome Total Care Strong MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de996aeb-9ac0-836f-e053-2a95a90aeda62025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
POP Hint Of MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05aafc53-49ca-eacd-e063-6394a90a606b2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
POP Gel Whatzzup WatermelonSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b18bb6-9fbf-469b-e063-6294a90a4f2f2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
AVON Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.9c820740-9148-3a9c-e053-2a95a90a39682025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
PERIOE Whitening Essentials Fresh Aloe Green MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.a3b21ceb-5aa5-29b4-e053-2a95a90a95452025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NeuropathEaseAGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEASilver Star Brands7809e54a-018d-9cf6-e053-2a91aa0aedfe2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
POP Gel Pumpin StrawberrySODIUM FLUORIDELG H&H Co., Ltd.05b25897-460c-2dfb-e063-6294a90ada3b2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H Co., Ltd.05b1f105-6f75-7a45-e063-6394a90a58bc2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
POP Hint Of MintSODIUM FLUORIDELG H&H Co., Ltd.05b25083-12f3-7a85-e063-6394a90a492e2025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
POP Gel Whatzzup WatermelonSODIUM FLUORIDELG H&H Co., Ltd.05b276a1-3778-104d-e063-6294a90a75372025-01-01WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
kids kareSTANNOUS FLUORIDEDEN-MAT HOLDINGS, LLC.66d7ae1f-ff7a-7fe4-e053-2991aa0a9f912024-12-31WarningsExact identifier
application number: M021
Kids KareSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.66d6b20f-d0ff-4dfe-e053-2991aa0a99ca2024-12-31WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Sensodyne Clinical White Intensive CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCf193ec40-032f-42c7-81f1-029ec89893742024-12-31WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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