Anticavity Fluoride Rinse

Product NDC: 36800-213
11-digit product format: 368000213
Labeler code: 36800
Product ID: 36800-213_4ab8141c-7913-66fb-e063-6394a90aa357
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Topco Associates LLC
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2003-10-20
Substance: SODIUM FLUORIDE
Active strength: .2 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Anticavity Fluoride Rinse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240698	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-213-44	Anticavity Fluoride Rinse	532 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	532		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-213	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]	15	Current NDC, Legacy NDC, 1 package rows	20250406_f760f8f8-0c74-4a6e-b5c9-cc82b8758a45.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 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SprinJene White Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	2026-08-14	Warnings	Exact identifier application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	2b123d70-4f7d-41b0-b48f-711999e97ee0	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE STRAWBERRY BURST	SODIUM FLUORIDE	Colgate-Palmolive Company	d037f65c-3d22-4d2a-a0a9-3dcba2357ebd	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd954777-697a-4cc7-8f5f-b2caf357ef95	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRY	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	e36ceb7a-9a29-41d8-8d08-a859e515f1f5	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	08d7ed04-67a4-437a-82c5-496f9893c6c7	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	27278b02-c4fd-4092-a632-a14e442f5a95	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICE	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	59a6b9ac-c28b-4ec3-8231-f35054ce0eaf	2026-08-10	Warnings	Exact identifier application number: M021
Toms Kids Watermelon Wiggle	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	64b60e74-fceb-4de9-a966-73bf8dbd666c	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	7e880d50-8aab-4d57-abc1-e900070f9a11	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	5cb5eb46-705c-4bb7-bef1-e93a598636fd	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	0e043431-9d87-478d-87f5-5aa8b0a932eb	2026-08-10	Warnings	Exact identifier application number: M021
Willo Minty Mist Dye Free	SODIUM FLUORIDE	Willo 32, Inc.	3ee5b49e-ca9a-ece6-e063-6394a90a3d00	2026-08-10	Warnings	Exact identifier application number: M021
Willo Bubble Twist	SODIUM FLUORIDE	Willo 32 Inc	36560d62-e901-1f93-e063-6394a90a2803	2026-08-10	Warnings	Exact identifier application number: M021
Willo Berry Splash Dye Free	SODIUM FLUORIDE	Willo 32, Inc	3ea91af9-2895-e530-e063-6394a90a39e5	2026-08-10	Warnings	Exact identifier application number: M021
Fluoride Mouth Rinse Anticavity	SODIUM FLUORIDE	Target Corporation	3daf3cc3-585a-4bb2-9b56-7117d220ed38	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	19de1e71-ab94-415f-b66d-e5748dea8317	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	d5e1396e-0253-4ec0-a9ff-b61bda70de35	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED COOL MILD MINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	de92408c-d401-47c3-94ee-fb6c08092651	2026-08-10	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	16
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	16
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-213-44	36800021344	532 mL in 1 BOTTLE, PLASTIC (36800-213-44)	532 ml	2003-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 213.002/213AE rev 2 Anticavity Fluoride Rinse, Mint	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	16