sodium fluoride rinse

Product NDC: 69892-971
11-digit product format: 698920971
Labeler code: 69892
Product ID: 69892-971_52430b12-4d60-d1e1-e063-6394a90abd64
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride rinse
Dosage form: LIQUID
Route: ORAL
Labeler: Rockland Cosmetics, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-05-20
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: sodium fluoride rinse
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
52430b12-4d5f-d1e1-e063-6394a90abd64	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69892-971-86	sodium fluoride rinse	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000		1

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 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Complete plus Whitening plus Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c5d5bc17-e81b-34aa-e053-2a95a90ad77f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c5745cc4-213d-1dde-e053-2995a90af562	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Shield	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	960fef18-4533-5250-e053-2995a90aaf76	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c574b51d-07bd-b363-e053-2995a90a7c0e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Blast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d9a1754-8d38-054f-e053-2991aa0a4653	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Breath Purify and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c60fdacf-d997-19a5-e053-2a95a90a96a3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	3d7fffb9-47e0-73cd-e054-00144ff88e88	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Ultra	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c73ed36a-0e2f-a137-e053-2a95a90a43e0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Extra Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c688d37e-9e80-4599-e053-2a95a90a1916	2026-01-08	Warnings	Exact identifier application number: M021
Crest Gum Detoxify plus Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	63779942-0f6c-11c5-e053-2991aa0a25ab	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Sensitivity Active Foam	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	b8535d1c-cf15-f353-e053-2a95a90a7974	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Extra White Zen Peppermint	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	81279e1f-6224-8114-e053-2991aa0aab08	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c74229c4-b095-df32-e053-2a95a90a4aec	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh Mint	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	c8350ab3-9347-58c0-e053-2995a90a7238	2026-01-08		Exact identifier application number: M021
Crest Premium Plus Anti-Bacterial	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	b7af946e-1cac-b8c0-e053-2a95a90afa4a	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Polishing Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	ddcb0871-9900-125f-e053-2a95a90a75de	2026-01-08		Exact identifier application number: M021
Burts Bees Deep Clean plus Whitening	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c924b8dd-8d84-1329-e053-2995a90a4531	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	07ed767e-225c-e9c5-e063-6394a90af931	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	0813171e-bda5-b004-e063-6394a90ad364	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Kids Strawberry Splash	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	087b3434-2636-74ce-e063-6394a90a25ad	2026-01-08	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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1485590	sodium fluoride Mouthwash [CTx3 Rinse]	sodium fluoride Mouthwash [CTx3 Rinse]	SBDF Active
1488070	sodium fluoride Mouthwash [ProDenRx Rinse]	sodium fluoride Mouthwash [ProDenRx Rinse]	SBDF Active

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	52430b12-4d5f-d1e1-e063-6394a90abd64	1
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	52430b12-4d5f-d1e1-e063-6394a90abd64	1
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	52430b12-4d5f-d1e1-e063-6394a90abd64	1
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	52430b12-4d5f-d1e1-e063-6394a90abd64	1

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	52430b12-4d5f-d1e1-e063-6394a90abd64	1
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	52430b12-4d5f-d1e1-e063-6394a90abd64	1
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	52430b12-4d5f-d1e1-e063-6394a90abd64	1
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	52430b12-4d5f-d1e1-e063-6394a90abd64	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69892-971-86	69892097186	1000 mL in 1 BOTTLE, PLASTIC (69892-971-86)	1000 ml	2026-05-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MINT'EVO 971.001/971AB Burn-Free Fluoride Anti-Cavity Mouthwash	Rockland Cosmetics, Inc. \| Nice-Pak Products, LLC	2026-05-20	HUMAN OTC DRUG LABEL	1

sodium fluoride rinse

Reported adverse events (FAERS/openFDA)#

Additional Listing Data#

Active Ingredients#

Harmonized UNII identifiers#

Harmonized RxCUI identifiers#

Harmonized SPL set identifiers#

DailyMed Package Descriptions#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#