Opalescence Whitening

Product NDC: 51206-314
11-digit product format: 512060314
Labeler code: 51206
Product ID: 51206-314_5b14bdd2-2852-1c00-e063-6294a90ac4cc
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Ultradent Products, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-09-23
Marketing end: 2031-01-31
Substance: SODIUM FLUORIDE
Active strength: 1.1 mg/g
NDC exclude flag: No
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: Opalescence Whitening
Brand name suffix: Cool Mint

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1.1 mg/g

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
416783	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
44e7d0ed-3c37-5889-e063-6294a90afcca	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51206-314-01	Opalescence WhiteningCool Mint	133 g in 1 TUBE	GEL, DENTIFRICE	133	3
51206-314-01	Opalescence WhiteningCool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	3
51206-314-02	Opalescence WhiteningCool Mint	12 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	12	3
51206-314-02	Opalescence WhiteningCool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	3
51206-314-03	Opalescence WhiteningCool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	3
51206-314-03	Opalescence WhiteningCool Mint	28 g in 1 TUBE	GEL, DENTIFRICE	28	3
51206-314-04	Opalescence WhiteningCool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	3
51206-314-04	Opalescence WhiteningCool Mint	24 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	24	3
51206-314-05	Opalescence WhiteningCool Mint	48 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	48	3
51206-314-05	Opalescence WhiteningCool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	3

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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CloSYS	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	ed617c7a-805c-4788-9bce-9b7fead4312d	2026-03-31	Warnings	Exact identifier application number: M021
Colgate Total Enamel Strength	STANNOUS FLUORIDE	Colgate-Palmolive Company	1f29c893-e7c5-4a0e-941b-c2634d821147	2026-03-25	Warnings	Exact identifier application number: M021
AP-24 Whitening	SODIUM MONOFLUOROPHOSPHATE	NSE Products, Inc.	57e9e68c-41dd-470b-80db-dfaedc0e2a0a	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369c0d44-6375-dcae-e063-6394a90a74d0	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369bc785-fb77-a56d-e063-6394a90a2e6b	2026-03-24	Warnings	Exact identifier application number: M021
SensitiveToothpaste	ANTI SENSITIVETOOTHPASTE	Huain Best Trade Co., Ltd.	4db239f3-2ad7-3a5b-e063-6294a90a11a7	2026-03-23	Warnings	Exact identifier application number: M021
Crest Bubblegum	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d6268c7-b273-1bbf-e053-2a91aa0a5d32	2026-03-17	Warnings	Exact identifier application number: M021
Natures Promise Childrens Fluoride Strawberry	SODIUM MONOFLUOROPHOSPHATE	Foodhold U.S.A.	81a4e196-8b2d-0745-e053-2991aa0a7de6	2026-03-16	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae8badf-f960-62fd-e054-00144ff8d46c	2026-03-11	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae71258-a8c2-6eb5-e054-00144ff88e88	2026-03-11	Warnings	Exact identifier application number: M021
Delta Travel Kit Comfort plus	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	d31e0920-4317-1e0c-e053-2a95a90aebeb	2026-03-11	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	CVS Pharmacy, Inc.	eac346d9-d9c1-4417-8193-390c7a0dcc2a	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6caf3f2e-70a2-4530-99fa-f5af7e4c511a	2026-03-10	Warnings	Exact identifier application number: M021
Amerfresh Toothpowder	SODIUM FLUORIDE	Yangzhou ONE & ONLY Personal Care Products Co., LTD	1cacf93e-aa60-4717-87ab-0568a701a4f3	2026-03-10	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	CVS Pharmacy, Inc.	a51357df-6d55-4030-a5db-42da7ba54a37	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M021
Fluoride	FLUORIDE TOOTHPASTE	McKesson	4c482e45-0502-a93a-e063-6394a90aa961	2026-03-05	Warnings	Exact identifier application number: M021
Colgate Maximum Cavity Protection Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	0a1389f6-cac9-3d58-0744-c488abb0bbcc	2026-03-03	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Amazon.com Services LLC	349eca80-2e0c-409b-af29-3235fdc0695b	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Amazon.com Services LLC	03735abc-d1be-4ca0-a497-0a5c5f289402	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Old East Main Co.	f8036e2e-7541-4922-92b9-0d8319f7b64c	2026-03-02	Warnings, Adverse reactions	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
416783	sodium fluoride 0.24 % Toothpaste	PSN	44e7d0ed-3c37-5889-e063-6294a90afcca	3
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	44e7d0ed-3c37-5889-e063-6294a90afcca	3
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	44e7d0ed-3c37-5889-e063-6294a90afcca	3
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	44e7d0ed-3c37-5889-e063-6294a90afcca	3
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	44e7d0ed-3c37-5889-e063-6294a90afcca	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51206-314-01	51206031401	1 TUBE in 1 CARTON (51206-314-01) / 133 g in 1 TUBE	1 tube	2025-09-23	2031-01-31	No	No	Historical
51206-314-02	51206031402	12 CARTON in 1 PACKAGE, COMBINATION (51206-314-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE	12 carton	2025-09-23	2031-01-30	No	No	Historical
51206-314-03	51206031403	1 TUBE in 1 CARTON (51206-314-03) / 28 g in 1 TUBE	1 tube	2025-09-23	2030-11-30	No	No	Historical
51206-314-04	51206031404	24 CARTON in 1 PACKAGE, COMBINATION (51206-314-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE	24 carton	2025-09-23	2030-11-30	No	No	Historical
51206-314-05	51206031405	48 CARTON in 1 PACKAGE, COMBINATION (51206-314-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE	48 carton	2025-09-23	2030-10-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Opalescence™ Whitening Toothpaste Original Cool Mint	Ultradent Products, Inc.	2026-09-09	HUMAN OTC DRUG LABEL	4