NDC 64778-0446-01 - Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse

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: 64778-0446
Requested NDC: 64778-0446-01
Package NDCs from labels: 64778-0446-1, 64778-0446-3, 64778-0446-01
Manufacturer: AMD Medicom
Effective date: 2026-03-05
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse - AMD Medicom	AMD Medicom	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64778-0446-1	Denti-Care Denti-RinseNeutral Sodium Fluoride Oral Rinse	1900 mL in 1 BOTTLE, PUMP	LIQUID	1900		8
64778-0446-3	Denti-Care Denti-RinseNeutral Sodium Fluoride Oral Rinse	12 in 1 CASE	LIQUID	12		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64778-0446	DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AMD MEDICOM]	7	Current NDC, Legacy NDC, 2 package rows	20210128_1da64824-9389-4109-bea9-b91600caf023.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AR MEDICOM INC]	1
fluoride ion	ACTIVE MOIETY	Q80VPU408O	DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AR MEDICOM INC]	1

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 7 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier unii: 8ZYQ1474W7
PreviDent 5000 Enamel Protect	SODIUM FLUORIDE AND POTASSIUM NITRATE	Colgate Oral Pharmaceuticals, Inc.	bbc66b1b-e05c-4e14-bef3-b8bae419fc89	2026-06-12	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
PreviDent OrthoDefense	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	99d37f3e-ac4f-4e8f-92e3-9b27d7632d35	2026-06-12	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier unii: 8ZYQ1474W7
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier unii: 8ZYQ1474W7
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier unii: 8ZYQ1474W7
PreviDent 5000 Dry Mouth	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	2026-06-10	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
PreviDent 5000 Kids	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	29a110f3-f407-fdfa-4346-937269ca849b	2026-06-10	Warnings, Adverse reactions	Exact identifier unii: 8ZYQ1474W7
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier unii: 8ZYQ1474W7
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	Warnings	Exact identifier unii: 8ZYQ1474W7
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Hello Unicorn Splash unicorn splash anticavity fluoride rinse	SODIUM FLUORIDE	Colgate-Palmolive Company	a1014431-7d23-aaff-6dc7-ab58683d0338	2026-06-02	Warnings	Exact identifier unii: 8ZYQ1474W7
Therabreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	feab3d45-ff95-4b32-8258-7d932a7380c9	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7
Orajel Toy Story 5 Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b80947d-f389-2f80-e063-6294a90abd55	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	54113245-0c1e-739e-e063-6294a90aea42	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	545258fd-8179-fffc-e063-6394a90a467f	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7
Orajel Paw Patrol	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d87bea-3e99-5d04-e053-2a95a90aaf54	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7
Orajel SuperMario	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	27d2f6cb-8661-da9c-e063-6394a90a5bde	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7
Orajel KidsToothpaste	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d62125-c2c5-5926-e053-2995a90aaa29	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7
AIM CAVITY PROTECTION Multi Benefit	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0f8a33-0b01-40e2-e054-00144ff88e88	2026-06-01	Warnings	Exact identifier unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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