Anticavity

Product NDC: 36800-971
11-digit product format: 368000971
Labeler code: 36800
Product ID: 36800-971_4aba08c6-5e06-e60a-e063-6394a90abde8
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: RINSE
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: 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
a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	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
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
36800-971-86	Anticavity	1000 mL in 1 BOTTLE, PLASTIC	RINSE	1000		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-971	ANTICAVITY (SODIUM FLUORIDE) RINSE [TOPCO ASSOCIATES LLC]	14	Current NDC, Legacy NDC, 1 package rows	20250328_a9b8b2fe-0a60-4f65-b6f6-aae8509c919f.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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	13910b55-9b5d-af53-e063-6294a90acf5d	2024-03-13	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	e3bb60f8-2a06-42d6-a182-8c31bb982a2a	2024-03-01	Warnings	Exact identifier application number: M021
Maximum Security	SODIUM FLUORIDE	Bob Barker Company Inc.	e29f30ec-72ea-4944-a2c2-b1696d31b639	2024-02-27	Warnings	Exact identifier application number: M021
Made by Dentists For Kids Monster Slime Sour Apple	SODIUM FLUORIDE	MADE BY DENTISTS INC	dfddc67c-3626-48c4-8120-bcc6c455d119	2024-02-23	Warnings	Exact identifier application number: M021
Orajel Gabbys Dollhouse	SODIUM FLUORIDE	Church & Dwight Co., Inc.	cd47bd1e-44ac-465f-8529-6073ade14706	2024-02-23	Warnings	Exact identifier application number: M021
Colgate Kids Maximum Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive	c44c7a7e-fc3e-a81b-1961-ff89614b678f	2024-02-22	Warnings	Exact identifier application number: M021
TheraBreath Fresh Breath Anticavity Mild Mint	SODIUM FLUORIDE	Church & Dwight Co., Inc.	19ce5324-7d8d-4d70-ad9b-238f7e612eac	2024-02-06	Warnings	Exact identifier application number: M021
Nature Mint Anticavity	SODIUM MONOFLUOROPHOSPHATE	Bob Barker Company Inc.	916891d3-5234-46a8-a492-21a31f36a852	2024-02-02	Warnings	Exact identifier application number: M021
Treatment Rinse Mint	ANTICARIES	DENTAL ALLIANCE HOLDINGS LLC	f1255065-b7c3-4eb6-e053-2995a90afcdb	2024-01-31	Warnings	Exact identifier application number: M021
Maintenance Rinse Mint	ANTICARIES	Dental Alliance Holdings LLC	f1273510-aa83-3ef9-e053-2a95a90aea27	2024-01-31	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98d839e3-a1aa-c83d-e053-2995a90a7e79	2024-01-30	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98aebbec-aec0-1478-e053-2a95a90a03ea	2024-01-30	Warnings	Exact identifier application number: M021
Toms Childrens Anticavity Mouthwash Silly Strawberry	SODIUM FLUORIDE	Tom's of Maine, Inc.	998c6f35-20f4-4cb8-bc48-6aa39e61481a	2024-01-18	Warnings	Exact identifier application number: M021
Gel-Kam Fruit and Berry	STANNOUS FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	2024-01-18	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	9a976ac8-d966-4d94-93da-45652f2d2481	2024-01-12	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	2b4b6f9a-0e31-4891-8721-d1b9a58cca96	2024-01-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	51abd6bc-7a3d-4b0e-a810-af9e94926438	2024-01-09	Warnings	Exact identifier application number: M021
Colgate Enamel Strength Mouthwash	SODIUM FLUORIDE	Colgate-Palmolive - do not use	f0cca38b-c0a3-4788-8cca-727a5684c16b	2024-01-09	Warnings	Exact identifier application number: M021
PerCara Oral Health Rinse Fresh Mint	CETYLPYRIDINIUM CHLORIDE	LEC Custom Products, Inc	bd98c654-218b-15ac-e053-2a95a90a75d1	2024-01-01	Warnings	Exact identifier application number: M021
PerCara Kids Bubble Gum	SODIUM FLUORIDE	LEC Custom Products, Inc.	be3a7272-acfb-7d14-e053-2995a90a9420	2024-01-01	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
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	15
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	15
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	15
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-971-86	36800097186	1000 mL in 1 BOTTLE, PLASTIC (36800-971-86)	1000 ml	2013-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 971.001/971AB Burn-Free Fluoride Anti-Cavity Mouthwash	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	15