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 36 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cloveden Sensitive Care Tooth	SODIUM FLUORIDE	DONG IL PHARMS CO.,LTD	3fb153f1-ba6e-7251-e063-6294a90abe62	2025-09-26	Warnings	Exact identifier application number: M021
Cloveden 100 times higher concentrated	CETYLPYRIDINIUM CHLORIDE	DONG IL PHARMS CO.,LTD	3fb1a2ee-381e-a9e8-e063-6394a90a864b	2025-09-26	Warnings	Exact identifier application number: M021
unpa Cha Cha Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Lycl Inc.	230b3cf2-053a-4e8b-8d50-05bbc877faa8	2025-09-25	Warnings	Exact identifier application number: M021
TheraBreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c5d58f1-ea8c-4708-bbc6-21e1cd1446da	2025-09-19	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1	2025-09-18	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	c1bbdd36-53fb-43a3-ba20-afbeb6359d31	2025-09-18	Warnings	Exact identifier application number: M021
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	f70d378b-d4d6-454c-90a9-794459960c8c	2025-09-17	Warnings	Exact identifier application number: M021
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	26b9b2dd-7cb2-47c3-8bbb-94a48f02dd21	2025-09-16	Warnings	Exact identifier application number: M021
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	3436532d-e078-4dbb-a823-b4542e961534	2025-09-16	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Fresh Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	9b1671c4-8680-6e2a-9f10-0400840ca5a9	2025-09-12	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	ddc09ce5-181a-1b50-7094-314bb58a15cf	2025-09-12	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint Anticavity Mouthwash	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	3efc66b2-fcf9-4d26-9cdd-1af8225312b4	2025-09-10	Warnings	Exact identifier application number: M021
CLOSE UP Freshening with Mouthwash	SODIUM FLUORIDE	Church & Dwight Co., Inc.	e660b0d7-4cc5-4028-bdf5-016b85899728	2025-09-09	Warnings	Exact identifier application number: M021
Essentials Healthy Teeth and Gums	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	9652c004-6b47-840f-e053-2995a90a6e98	2025-09-09	Warnings	Exact identifier application number: M021
Complete Care Whole Mouth Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	d00f9d16-de0e-4ffc-e053-2a95a90a2069	2025-09-09	Warnings	Exact identifier application number: M021
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	e911effb-d59f-4054-9501-803b64369ab4	2025-09-05	Warnings	Exact identifier application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	HISMILE PTY LTD	3de10638-1a39-b747-e063-6294a90a4ca5	2025-09-03	Warnings	Exact identifier application number: M021
Optimax Purple Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8264e849-a6b3-4953-a85b-da9d4e7f5a70	2025-09-02	Warnings	Exact identifier application number: M021
CAREKON ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.	3baca3b6-ff48-0579-e063-6394a90abd08	2025-08-29	Warnings	Exact identifier application number: M021
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Ashtel Studios, Inc.	fc794fe5-7135-4b2b-b002-a75908223f20	2025-08-13	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