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 30 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIPasteOne Kids Blue Raspberry	MI PASTE ONE KIDS BLUE RASPBERRY	GC America Inc.	bf7d668c-752a-2eee-e053-2a95a90add16	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Tutti Frutti	MIPASTE PLUS TUTTI FRUTTI	GC America Inc.	d724bd2a-2a8e-faeb-e053-2995a90aca19	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Vanilla	MIPASTE PLUS VANILLA	GC America Inc.	d7244125-1ca5-78ba-e053-2995a90ab764	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Melon	MIPASTE PLUS MELON	GC America Inc.	d724fe9f-c9ef-d9ad-e053-2995a90a7ecf	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Mint	MIPASTE PLUS MINT	GC America Inc.	d72415b3-c501-141f-e053-2995a90aaaa3	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Perio	MIPASTE ONE PERIO	GC America Inc.	d656b72d-48f8-4425-e053-2995a90ab1f2	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Blue Raspberry	MIPASTE ONE KIDS BLUE RASPBERRY	GC America Inc.	c07e1058-903b-fd47-e053-2995a90afdab	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Strawberry	MIPASTE PLUS STRAWBERRY	GC America Inc.	d7235ad7-83d7-12e5-e053-2a95a90aaeaf	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Cotton Candy	MIPASTE ONE KIDS COTTON CANDY	GC America Inc.	c07d6b50-1d67-ea7f-e053-2a95a90afbe4	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Bubble Gum	MIPASTE ONE KIDS BUBBLE GUM	GC America Inc.	c07c7853-763b-4383-e053-2995a90ab725	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One	MIPASTE ONE	GC America Inc.	d71f8e6e-7005-4b3e-e053-2995a90a6789	2025-12-19	Warnings	Exact identifier application number: M021
TheraBreath AM-PM Twin Pack	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4618e390-9039-a1d0-e063-6294a90ab294	2025-12-16	Warnings	Exact identifier application number: M021
Parodontax Gum Strengthen and Protect	STANNOUS FLUORIDE	Haleon US Holdings LLC	3bb40ceb-841b-4a25-e063-6294a90ab897	2025-12-15	Warnings	Exact identifier application number: M021
Sensodyne Pronamel Kids Bubble Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	41b1e626-e79b-d638-e063-6394a90a1f5b	2025-12-15	Warnings	Exact identifier application number: M021
Simple Truth Kids Flouride	SODIUM MONOFLUOROPHOSPHATE	Kroger Company	82b9db89-d108-3f64-e053-2991aa0aee74	2025-12-15	Warnings	Exact identifier application number: M021
Natural Adult Fluoride	SODIUM MONOFLUOROPHOSPHATE	Kroger	a71c537e-39d9-1c3b-e053-2a95a90ac3ec	2025-12-15	Warnings	Exact identifier application number: M021
Therabreath Overnight Chamomile Mint	SODIUM FLUORIDE	Church & Dwight Co., Inc.	cc0c533c-145e-4877-b421-1baf3a3a572e	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188d28f9-a814-0f98-e063-6294a90a106b	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b4cf935-38a6-f4fb-e063-6394a90a4bc0	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188cddb2-c799-0897-e063-6294a90a5d96	2025-12-11	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