FDA.reportPublic FDA data

Opalescence Sensitivity Relief Whitening

Product NDC
51206-308
11-digit product format
512060308
Labeler code
51206
Product ID
51206-308_5b14ddfe-ec8e-3a25-e063-6294a90afe5b
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
2015-11-30
Marketing end
2030-10-13
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 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 Sensitivity Relief Whitening

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086243Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5176a84-76a3-4ad0-a2e2-4997a12da9a5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
51206-308-01Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-01Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-02Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-02Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-03Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-03Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-04Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-04Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-05Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-05Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-06Opalescence™ Sensitivity Relief Whitening Toothpaste
51206-308-06Opalescence™ Sensitivity Relief Whitening Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-308-01Opalescence Sensitivity Relief Whitening28.35 g in 1 TUBEGEL, DENTIFRICE28.3511
51206-308-01Opalescence Sensitivity Relief Whitening1 in 1 CARTONGEL, DENTIFRICE111
51206-308-02Opalescence Sensitivity Relief Whitening1 in 1 CARTONGEL, DENTIFRICE111
51206-308-02Opalescence Sensitivity Relief Whitening133 g in 1 TUBEGEL, DENTIFRICE13311
51206-308-03Opalescence Sensitivity Relief Whitening3 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE311
51206-308-03Opalescence Sensitivity Relief Whitening1 in 1 CARTONGEL, DENTIFRICE111
51206-308-04Opalescence Sensitivity Relief Whitening1 in 1 CARTONGEL, DENTIFRICE111
51206-308-04Opalescence Sensitivity Relief Whitening12 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE1211
51206-308-05Opalescence Sensitivity Relief Whitening1 in 1 CARTONGEL, DENTIFRICE111
51206-308-05Opalescence Sensitivity Relief Whitening24 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE2411
51206-308-06Opalescence Sensitivity Relief Whitening1 in 1 CARTONGEL, DENTIFRICE111
51206-308-06Opalescence Sensitivity Relief Whitening6 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE611

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium NitrateACTIVE INGREDIENTRU45X2JN0ZOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Fluoride IonACTIVE MOIETYQ80VPU408OOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Nitrate IonACTIVE MOIETYT93E9Y2844OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022YOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25ROPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0ROPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1EOPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-308OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]9Current NDC, Legacy NDC, 12 package rows20240224_b5176a84-76a3-4ad0-a2e2-4997a12da9a5.zip

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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.af430cf4-f1b4-4b57-b8e3-87df96d655d32025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.2b089fec-cae3-4dc9-964d-d37f732a2f9f2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.6c137a93-4a34-4849-997f-bd0c572466ef2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.e8aa9709-e8f6-47a6-ab29-1fef2309786b2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNb5176a84-76a3-4ad0-a2e2-4997a12da9a511
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDb5176a84-76a3-4ad0-a2e2-4997a12da9a511
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYb5176a84-76a3-4ad0-a2e2-4997a12da9a511
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYb5176a84-76a3-4ad0-a2e2-4997a12da9a511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-308-01512060308011 TUBE in 1 CARTON (51206-308-01) / 28.35 g in 1 TUBE1 tube2015-11-302030-10-13NoNoCurrent
51206-308-02512060308021 TUBE in 1 CARTON (51206-308-02) / 133 g in 1 TUBE1 tube2015-11-302030-10-13NoNoCurrent
51206-308-03512060308033 CARTON in 1 PACKAGE, COMBINATION (51206-308-03) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE3 carton2015-11-302030-10-13NoNoCurrent
51206-308-045120603080412 CARTON in 1 PACKAGE, COMBINATION (51206-308-04) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE12 carton2015-11-302030-10-13NoNoCurrent
51206-308-055120603080524 CARTON in 1 PACKAGE, COMBINATION (51206-308-05) / 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE24 carton2015-11-302030-10-13NoNoCurrent
51206-308-06512060308066 CARTON in 1 PACKAGE, COMBINATION (51206-308-06) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE6 carton2015-11-302030-10-13NoNoCurrent