FDA.reportPublic FDA data

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
IngredientStrength
SODIUM FLUORIDE1.1 mg/g
POTASSIUM NITRATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44e94663-895b-67da-e063-6394a90a5fe6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-315-01Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-01Opalescence Whitening Sensitivity Relief133 g in 1 TUBEGEL, DENTIFRICE1332
51206-315-02Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-02Opalescence Whitening Sensitivity Relief12 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE122
51206-315-03Opalescence Whitening Sensitivity Relief28 g in 1 TUBEGEL, DENTIFRICE282
51206-315-03Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-04Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-04Opalescence Whitening Sensitivity Relief24 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE242
51206-315-05Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-05Opalescence Whitening Sensitivity Relief48 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE482

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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
application number: M022
Dual-FormulaToothpaste for sensitive teethDUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETHHangzhou Namei Zhikang Technology Co., Ltd.4d735f91-8abc-3a30-e063-6394a90a76392026-03-20WarningsExact identifier
application number: M022
SmileCare Mouth Ulcer GelMENTHOLYantai Aien Biotechnology Co., Ltd.4d6db039-5b97-8f3f-e063-6294a90a9d852026-03-19WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f91e609-8ca5-0492-e053-2a95a90a85d02026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f81ffa5-05fd-4eef-e053-2995a90aac3e2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947366-9380-3fa9-e053-2a95a90ad49c2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947672-4873-5546-e053-2a95a90a3c4b2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f9490c1-8bfe-3166-e053-2a95a90a71752026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f94b65d-47e3-9c6b-e053-2a95a90aa1f82026-03-17WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c00a6-1346-7780-e063-6294a90a3d5a2026-03-12WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINENantong Health & Beyond Hygienic Products Inc.a5f0be98-d47e-4307-8044-304a64db774b2026-03-11WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDECVS Pharmacy, Inc.a5dbaadf-76a8-4c48-af2d-f4455e9411f02026-03-09Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDESam's West, Inc78a3e024-73da-40b7-9d9c-099fd6ca9b9e2026-03-03WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
application number: M022
Spring Gene Oil Pulling SensitivityPOTASSIUM NITRATEHealth and Natural Beauty USA Corp294051e3-69ec-4190-8b03-fa34988376b72026-02-26WarningsExact identifier
application number: M022
Lolleez WatermelonPECTINBFY LLC4ba8af8b-5a17-8b8c-e063-6394a90a63f32026-02-25WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLH E Bf1450866-1be4-46d9-9fe4-52d699636b4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD44e94663-895b-67da-e063-6394a90a5fe62
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-315-01512060315011 TUBE in 1 CARTON (51206-315-01) / 133 g in 1 TUBE1 tube2025-10-082030-12-31NoNoHistorical
51206-315-025120603150212 CARTON in 1 PACKAGE, COMBINATION (51206-315-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE12 carton2025-10-082030-12-31NoNoHistorical
51206-315-03512060315031 TUBE in 1 CARTON (51206-315-03) / 28 g in 1 TUBE1 tube2025-10-082030-12-31NoNoHistorical
51206-315-045120603150424 CARTON in 1 PACKAGE, COMBINATION (51206-315-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE24 carton2025-10-082030-12-31NoNoHistorical
51206-315-055120603150548 CARTON in 1 PACKAGE, COMBINATION (51206-315-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE48 carton2025-10-082030-12-31NoNoHistorical