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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Total Care Zero Alcohol Anticavity Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	4b594a6e-db1d-443b-bfa7-23ee15749f47	2024-12-19	Warnings	Exact identifier application number: M021
NewYork-Presbyterian Amenity	SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	4b307471-445d-4c51-a499-d074a8172f20	2024-12-17	Warnings	Exact identifier application number: M021
Colgate Anticavity	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive (Thailand) Limited - Branch	5bc0b430-6f68-4e52-a1da-de19136eaeac	2024-12-09	Warnings	Exact identifier application number: M021
CURODONT REPAIR FLUORIDE PLUS	SODIUM FLUORIDE	CREDENTIS AG	03ec09f9-4281-9ccb-e063-6294a90aadd8	2024-12-01	Warnings	Exact identifier application number: M021
CURODONT PROTECT	STANNOUS FLUORIDE	CREDENTIS AG	03ec591c-68c3-a380-e063-6394a90a131a	2024-12-01	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Bubble Gum Blowout	SODIUM FLUORIDE	Chattem, Inc.	61f3a3e6-645b-4368-b1d5-7de1fc14542e	2024-12-01	Warnings	Exact identifier application number: M021
SparkleFresh Flouride Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Medline Industries, LP	1565528b-89f2-4c97-b294-15b6ebd3f80e	2024-11-26	Warnings	Exact identifier application number: M021
Rembrandt Intense Stain	SODIUM FLUORIDE	Ranir LLC	55dcd063-5661-35aa-e054-00144ff8d46c	2024-11-26	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	9f98913f-6754-4e1c-98cf-b89fe87750f8	2024-11-25	Warnings	Exact identifier application number: M021
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
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	2a882210-49e6-4b9c-a2c6-eaa37b6514c3	2024-11-25	Warnings	Exact identifier application number: M021
Pepsodent Complete Care Original	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c6931cb-0ec9-41bb-b410-c355573aab57	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Strawberry Natural Fluoride	SODIUM FLUORIDE	Ranir LLC	8ee37955-fe1a-4964-ac29-d1d7dfb694cc	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	abdc7f79-5f87-4307-8ddd-e6281ac67a04	2024-11-20	Warnings	Exact identifier application number: M021
AIM Bubble Berry	SODIUM FLUORIDE	Church & Dwight Co., Inc.	c83ccdea-d75f-4084-853e-ed4bab9a12d4	2024-11-20	Warnings	Exact identifier application number: M021
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
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
Enamel Defense	SODIUM FLUORIDE	Church & Dwight Co., Inc.	9e8f1ce9-b161-50db-e053-2995a90ad32b	2024-11-20	Warnings	Exact identifier application number: M021
Rembrandt Deeply White Plus Peroxide	SODIUM MONOFLUOROPHOSPHATE	Ranir LLC	bf7da007-ab9d-4631-bc28-6ca245fd6265	2024-11-20	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