Alcohol-Free Anticavity

Product NDC: 36800-482
11-digit product format: 368000482
Labeler code: 36800
Product ID: 36800-482_4ab9671f-9d7c-0b2a-e063-6294a90a50d0
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium fluoride
Dosage form: LIQUID
Route: ORAL
Labeler: Topco Associates LLC
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-19
Substance: SODIUM FLUORIDE
Active strength: .1 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: Alcohol-Free Anticavity
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.1 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
313029	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
ade7dcb2-b4e2-4cef-b9a7-469867ead68a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-482-86	Alcohol-Free Anticavity	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000		21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-482	ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [TOPCO ASSOCIATES LLC]	19	Current NDC, Legacy NDC, 1 package rows	20240919_ade7dcb2-b4e2-4cef-b9a7-469867ead68a.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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ed8e02-3c2f-750c-e063-6394a90a4d33	2026-06-23	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	c68b0644-685d-4c62-bf5d-3a5bbea3b052	2026-06-22	Warnings, Adverse reactions	Exact identifier application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	fdbadaae-eab7-4d9a-acf7-815ca93f877c	2026-06-16	Warnings	Exact identifier application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	ebb62015-0027-459a-a9cf-56b640f9f456	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	b9962eac-186e-4da2-929d-393f18ed0234	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	1c029b10-29b0-4131-9134-cebfca4328a3	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	3e7ab39a-989c-4924-af3e-689404912bee	2026-06-16	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	7f6b6aa8-50da-151b-c448-9e427d37398f	2026-06-11	Warnings	Exact identifier application number: M021
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total Sensitivity Mineral Shield	STANNOUS FLUORIDE	Colgate-Palmolive Company	f065318c-1e2a-c04d-f254-f8127b05a88f	2026-06-10	Warnings	Exact identifier application number: M021
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier application number: M021
Colgate Total SF Fresh Mint Stripe	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	657020c7-e85c-4c61-9f62-b50351e4b4e5	2026-06-10	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Bubblegum	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	1adc752b-2ba8-4d8f-b4f1-5741f864255b	2026-06-09	Warnings	Exact identifier application number: M021
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier application number: M021
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Raspberry	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	57e1d1cb-da58-4cd2-b960-4056e0b0d214	2026-06-05	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteeth	POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fc83e-a8cf-15c1-e063-6294a90a7b74	2026-06-02	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
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	21
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	21
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	21
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-482-86	36800048286	1000 mL in 1 BOTTLE, PLASTIC (36800-482-86)	1000 ml	2013-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 482.002/482AC Alcohol Free Fluoride Violet Mint Mouthwash	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	21