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 38 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CURODONT REPAIR FLUORIDE PLUS	SODIUM FLUORIDE	CREDENTIS AG	290c57b0-a562-0a51-e063-6294a90a0720	2025-06-23	Warnings	Exact identifier application number: M021
KarlnHans Fresh Breath Jasmine Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	384863bd-b2cb-a46d-e063-6394a90a3ce2	2025-06-23	Warnings	Exact identifier application number: M021
KarlnHans Fresh Breath Double Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	38487130-9508-a2c4-e063-6394a90aa323	2025-06-23	Warnings	Exact identifier application number: M021
Crest Kids SparkleFun Bubblegum	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	01f0e81a-03bf-e17f-e063-6394a90a7358	2025-06-12	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	2ee626d1-6150-87db-e063-6294a90a64d8	2025-06-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh Citrus Fresh	SODIUM FLUORIDE	Colgate-Palmolive Company	13a74642-51d2-493c-ae97-a54508546a74	2025-06-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh Watermelon Blast	SODIUM FLUORIDE	Colgate-Palmolive Company	4f07f945-6594-40f4-bc19-6acc12c37cdd	2025-06-12	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	36994628-e5f3-3c35-e063-6294a90a609d	2025-06-02	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SET	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	35bfa3fc-106e-aecc-e063-6294a90a7eb0	2025-05-22	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369aa02f-c312-6a0d-e063-6294a90adaa5	2025-05-22	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING TRAVEL	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	3596306e-858c-9bf7-e063-6294a90ac1d6	2025-05-20	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	3582cc91-8c32-9f93-e063-6394a90a8792	2025-05-19	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING SET	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	35839b10-4c40-40e5-e063-6294a90a85b4	2025-05-19	Warnings	Exact identifier application number: M021
Hello Unicorn Sparkle	SODIUM FLUORIDE	Colgate-Palmolive Company	5acfbd9b-278c-24dd-8041-5e2cdffbf710	2025-05-13	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Cotton Candy	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	25f182cb-ad1e-4c13-bc79-1ec251754cf8	2025-05-12	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Watermelon	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	b506df13-649f-4615-bc25-6ae08bd56b18	2025-05-12	Warnings	Exact identifier application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	346daeae-7590-176c-e063-6294a90a52ea	2025-05-05	Warnings	Exact identifier application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	3de0d71a-7704-97dd-e063-6294a90a5d2c	2025-05-01	Warnings	Exact identifier application number: M021
Brush Buddies Value 2 pack Whitening	SODIUM MONOFLUOROPHOSPHATE	Ashtel Studios, Inc	636bf51d-9750-4305-ab4a-3483c9f0169b	2025-04-30	Warnings	Exact identifier application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope	SODIUM FLUORIDE	Navajo Manufacturing Company Inc	3adb1524-0fd6-4728-b757-dcbda4cdd0fb	2025-04-29	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#