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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moon Charcoal Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c55f7b3-fea1-58f3-e063-6394a90a3bde	2023-12-12	Warnings	Exact identifier application number: M022
ORCA Complete Menthol Pain Reliever	MENTHOL	ORCA Products, LLC	99990e27-d66b-4d61-97f2-6a76066eb8b8	2023-12-08	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	0070858b-e02e-431f-a7c2-313fef01791b	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	d1802f08-80cb-41dd-b34d-9c576b101ddb	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	80182c43-100f-4b15-a07e-819599ab9562	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c19e6426-8f1e-47b3-a3a6-551a5bec6cd9	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1f8431bb-f33c-4fd8-9472-9b59ffb5f18e	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1163d248-d648-443e-bed0-ccb7fd26ba63	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	88caabe2-a096-44d0-98d3-afad1935c012	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c1b02a2f-db1f-44f0-a74a-d02c085c5bd7	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	39081585-fe6a-4ba1-93f8-d92d26fe75bc	2023-12-07	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d7c69357-795c-03d8-e053-2a95a90a03a6	2023-12-06	Warnings	Exact identifier application number: M022
Dr. Sheffield Sensitive Care	SENSITIVE TOOTH PASTE	Sheffield Pharmaceuticals LLC	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	2023-11-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f3bf106c-5320-ced2-e053-2a95a90a71ac	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b517321-25ed-2676-e063-6294a90ab4c9	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b51b67c-03ac-5730-e063-6394a90a5060	2023-11-29	Warnings	Exact identifier application number: M022
Pearl White	POTASSIUM NITRATE, SODIUM FLUORIDE	Beyond International Inc.	51c79544-9536-5863-e054-00144ff8d46c	2023-11-28	Warnings	Exact identifier application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE AND SODIUM FLUORIDE	Universal Distribution Center LLC	fcf59439-7e06-4129-a89f-cdeecdf8d488	2023-11-17	Warnings	Exact identifier application number: M022
PerioRestore	HYDROGEN PEROXIDE	DEN-MAT HOLDINGS, LLC.	97a07c36-1af8-a636-e053-2a95a90ad6db	2023-11-13	Warnings	Exact identifier application number: M022
Wild Horse 777 Oral	PHENOL	Wild Horse 777, Inc.	b0b517bb-969f-0c65-e053-2995a90a48b1	2023-11-10	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