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
Label	Manufacturer	Effective date	Type
DawnMist Gel Fluoride - Dukal LLC	Dukal LLC	2025-02-07	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65517-2004-0	DawnMist Gel Fluoride	78 g in 1 TUBE	GEL, DENTIFRICE	78	3
65517-2004-1	DawnMist Gel Fluoride	17 g in 1 TUBE	GEL, DENTIFRICE	17	3
65517-2004-2	DawnMist Gel Fluoride	24 g in 1 TUBE	GEL, DENTIFRICE	24	3
65517-2004-3	DawnMist Gel Fluoride	43 g in 1 TUBE	GEL, DENTIFRICE	43	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65517-2004	DAWNMIST GEL FLUORIDE (GEL FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [DUKAL LLC]	3	Current NDC, 4 package rows	20250210_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 77 of 109 · 2,164 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%	PURIFIED WATER 98.3%	Acme United Corporation	9248ee71-2d47-620d-e053-2995a90af5c8	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution Eyewash	PURIFIED WATER 98.3%	Acme United Corporation	cca454e0-b2bd-4215-bc06-426fcc3f7bd6	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution Eyewash	PURIFIED WATER 98.3%	Acme United Corporation	d3812fa3-9334-464d-b50c-98548ff76727	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R
DANGTTEOL	MINERAL WATER	AQBC CO., LTD	27db14a9-3812-433f-e063-6394a90a11e7	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R
Rembrandt Intense Stain	SODIUM FLUORIDE	Ranir LLC	55dcd063-5661-35aa-e054-00144ff8d46c	2024-11-26	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	9f98913f-6754-4e1c-98cf-b89fe87750f8	2024-11-25	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	88f87f7a-5b2d-47c9-8830-6b88b4ddbb59	2024-11-25	Warnings	Exact identifier application number: M021
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	0c85d273-3b98-43ea-81ba-c90f70ab72f8	2024-11-25	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	2a882210-49e6-4b9c-a2c6-eaa37b6514c3	2024-11-25	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	2787f88c-752e-cbaa-e063-6394a90a732c	2024-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Pepsodent Complete Care Original	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c6931cb-0ec9-41bb-b410-c355573aab57	2024-11-21	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Firefly Strawberry Natural Fluoride	SODIUM FLUORIDE	Ranir LLC	8ee37955-fe1a-4964-ac29-d1d7dfb694cc	2024-11-21	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	abdc7f79-5f87-4307-8ddd-e6281ac67a04	2024-11-20	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Hempvana Ultra Pain Relief - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	f93a1ed0-5046-0355-e053-6294a90a6a90	2024-11-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM	Energetix Corporation	37063a49-6b45-4167-875d-49c9dac3f79b	2024-11-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
AIM Bubble Berry	SODIUM FLUORIDE	Church & Dwight Co., Inc.	c83ccdea-d75f-4084-853e-ed4bab9a12d4	2024-11-20	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
AIM TARTAR CONTROL Plus Mouthwash and Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0fc71c-d28e-4afa-e054-00144ff8d46c	2024-11-20	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Advance White Tartar Control Breath Freshening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	aa8be8f5-ba46-4b1b-afaa-58fddf8f8780	2024-11-20	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Enamel Defense	SODIUM FLUORIDE	Church & Dwight Co., Inc.	9e8f1ce9-b161-50db-e053-2995a90ad32b	2024-11-20	Warnings	Exact identifier application number: M021 unii: 8ZYQ1474W7
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	e91ed8a1-0d45-402c-9c16-1ae72e695a37	2024-11-20	Warnings	Exact identifier unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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