Opalescence Whitening Sensitivity Relief

Product NDC: 51206-315
11-digit product format: 512060315
Labeler code: 51206
Product ID: 51206-315_5b14ca86-96a0-7c20-e063-6394a90af5bd
Type: HUMAN OTC DRUG
Nonproprietary name: Potassium Nitrate and Sodium Fluoride
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Ultradent Products, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-08
Marketing end: 2030-12-31
Substance: SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength: 1.1; 50 mg/g; 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 Sensitivity Relief

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1.1 mg/g
POTASSIUM NITRATE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup
RU45X2JN0Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038929	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
44e94663-895b-67da-e063-6394a90a5fe6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51206-315-01	Opalescence Whitening Sensitivity Relief	1 in 1 CARTON	GEL, DENTIFRICE	1	2
51206-315-01	Opalescence Whitening Sensitivity Relief	133 g in 1 TUBE	GEL, DENTIFRICE	133	2
51206-315-02	Opalescence Whitening Sensitivity Relief	1 in 1 CARTON	GEL, DENTIFRICE	1	2
51206-315-02	Opalescence Whitening Sensitivity Relief	12 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	12	2
51206-315-03	Opalescence Whitening Sensitivity Relief	28 g in 1 TUBE	GEL, DENTIFRICE	28	2
51206-315-03	Opalescence Whitening Sensitivity Relief	1 in 1 CARTON	GEL, DENTIFRICE	1	2
51206-315-04	Opalescence Whitening Sensitivity Relief	1 in 1 CARTON	GEL, DENTIFRICE	1	2
51206-315-04	Opalescence Whitening Sensitivity Relief	24 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	24	2
51206-315-05	Opalescence Whitening Sensitivity Relief	1 in 1 CARTON	GEL, DENTIFRICE	1	2
51206-315-05	Opalescence Whitening Sensitivity Relief	48 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	48	2

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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitivity Relief Fluoride Free	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	c23b2a83-ebc3-4bcf-a216-7693944dcfa0	2026-05-22	Warnings	Exact identifier application number: M022
Sensitivity and Gum with Cavity Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Health and Natural Beauty USA Corp	137d6935-19a3-499d-957c-820156eec7a5	2026-05-22	Warnings	Exact identifier application number: M022
SEXYTEETH MINTY T00THPASTE	SEXYTEETH MINTY TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51d288c1-fe86-ffe1-e063-6394a90ab4c4	2026-05-14	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat cherry	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	2026-05-12	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat honey lemon	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	d771095b-7de3-48f3-a125-8bc76e7d1778	2026-05-12	Warnings	Exact identifier application number: M022
SEXYTEETH CHARCOAL T00THPASTE	SEXYTEETH CHARCOAL TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51ab8a9a-6c12-b13b-e063-6294a90ace2a	2026-05-12	Warnings	Exact identifier application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity	FLUORIDE	WHOLE FOODS	25bc7ab1-116d-143a-e063-6394a90aa970	2026-05-04	Warnings	Exact identifier application number: M022
Gingicaine Gel Strawberry	GINGICAINE GEL STRAWBERRY FLAVOR	Gingi-Pak a Division of the Belport	2fd37612-a28b-3aa1-e054-00144ff8d46c	2026-05-01	Warnings	Exact identifier application number: M022
3ECARE Dual formula WhiteningToothpaste Refill	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	501df1c7-4884-bb39-e063-6294a90aaf6a	2026-04-23	Warnings	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	1f10a72f-0b49-41cb-92f9-b0160d7664de	2026-04-22	Warnings	Exact identifier application number: M022
EverSmile AlignerFresh Enamel Guard	SODIUM FLUORIDE	Everbrands, Inc.	7b3d0114-dac0-4370-8545-922ec018018e	2026-04-21	Warnings	Exact identifier application number: M022
PREOP	HYDROGEN PEROXIDE	Everbrands, Inc.	cc5cdd29-92c1-4ce0-997e-eb624b288b09	2026-04-20	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	CVS	a7576238-e7c8-7e86-e053-2995a90aaeb5	2026-04-20	Warnings	Exact identifier application number: M022
CVS Pharmacy Maximum Strength	BENZOCAINE	CVS Pharmacy	92747826-cf58-4406-b3b5-12f7c7077c2c	2026-04-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	9f991292-bbaa-4f4e-b2cb-059d1a04849e	2026-04-20	Warnings	Exact identifier application number: M022
Osstem S Sensitivity relief tooth	POTASSIUM NITRATE, SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8ab179-8f29-a7cf-e063-6294a90a0c22	2026-04-15	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum DetoxifyWinter Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6db58f-0b09-d155-e063-6394a90ae658	2026-04-14	Warnings	Exact identifier application number: M022
Lolleez Orange Mango	PECTIN	BFY LLC	4f6dec8b-078a-f321-e063-6294a90a248c	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Restore Smooth Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6e3b36-e565-7d27-e063-6294a90ae5ac	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Nightly Bacteria Shield	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6ec1e0-c6b5-226f-e063-6294a90a8f14	2026-04-14	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	44e94663-895b-67da-e063-6394a90a5fe6	2
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	44e94663-895b-67da-e063-6394a90a5fe6	2
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	44e94663-895b-67da-e063-6394a90a5fe6	2
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	44e94663-895b-67da-e063-6394a90a5fe6	2
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	44e94663-895b-67da-e063-6394a90a5fe6	2
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	44e94663-895b-67da-e063-6394a90a5fe6	2
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	44e94663-895b-67da-e063-6394a90a5fe6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51206-315-01	51206031501	1 TUBE in 1 CARTON (51206-315-01) / 133 g in 1 TUBE	1 tube	2025-10-08	2030-12-31	No	No	Historical
51206-315-02	51206031502	12 CARTON in 1 PACKAGE, COMBINATION (51206-315-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE	12 carton	2025-10-08	2030-12-31	No	No	Historical
51206-315-03	51206031503	1 TUBE in 1 CARTON (51206-315-03) / 28 g in 1 TUBE	1 tube	2025-10-08	2030-12-31	No	No	Historical
51206-315-04	51206031504	24 CARTON in 1 PACKAGE, COMBINATION (51206-315-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE	24 carton	2025-10-08	2030-12-31	No	No	Historical
51206-315-05	51206031505	48 CARTON in 1 PACKAGE, COMBINATION (51206-315-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE	48 carton	2025-10-08	2030-12-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Opalescence™ Whitening Toothpaste Sensitivity Relief	Ultradent Products, Inc. \| Ultradent Products, Inc	2026-09-09	HUMAN OTC DRUG LABEL	3