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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact 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