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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Kids Space Jam Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	54cbfb09-8fd7-ef08-99fd-14fc019c81ff	2024-11-14	Warnings	Exact identifier application number: M021
Colgate Kids Llama Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive	a7b02cb2-cfb3-7b35-42da-7924d156dcc3	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	82bc1101-84d7-4e21-be9c-870ad88a4b7c	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	COLGATE PALMOLIVE COMPANY	b6ca4ec7-5087-4693-82b7-199b44d7f931	2024-11-13	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Clinical Solutions Teeth Strength Alpine Mint	SODIUM FLUORIDE	Kenvue Brands LLC	06e2de03-4a58-3de0-e063-6294a90a5857	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	ee9a962d-83c7-4b13-bff6-140e48785e8a	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield	SODIUM FLUORIDE	Kenvue Brands LLC	d69d2e0d-a3e3-4d95-992d-c0c59172b3a5	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast	SODIUM FLUORIDE	Kenvue Brands LLC	f09f334b-709c-473e-b91e-3f31480ceb90	2024-11-11	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	LG H&H Co.,Ltd.	2697fa68-b991-ab09-e063-6394a90aec4c	2024-11-01	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	Tai Guk Pharma. Co., Ltd.	2698d6d8-051b-6c10-e063-6394a90a9418	2024-11-01	Warnings	Exact identifier application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)	SODIUM FLUORIDE	MADE BY DENTISTS INC	263c448b-728f-4370-bcdb-148d614d9b34	2024-10-30	Warnings	Exact identifier application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	17f589e9-f4ba-46d3-a345-db38f9a9067d	2024-10-17	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Wild Watermelon	SODIUM FLUORIDE	Chattem, Inc.	8d7faeab-ac70-472a-acbb-de67493718ce	2024-10-16	Warnings	Exact identifier application number: M021
Rexall Restore and Defend Sensitive Whitening	STANNOUS FLUORIDE	Old East Main CO.	691c9638-75d2-4e53-bec4-2eafacd7216c	2024-10-14	Warnings	Exact identifier application number: M021
Rexall Travel Toothbrush and Tooth-paste	SODIUM MONOFLUOROPHOSPHATE	Old East Main CO.	1bfba18b-1418-4c39-b666-96fa0674cc70	2024-10-14	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Navajo Manufacturing Company Inc.	23851360-e30e-dd97-e063-6394a90a5474	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	36cd9cfc-7390-4400-8ede-b9d172d83953	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	85e83b72-2d09-aec0-db7e-6b5715c5a86c	2024-10-01	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