FDA.reportPublic FDA data

Opal by Opalescence Sensitivity

Product NDC
51206-311
11-digit product format
512060311
Labeler code
51206
Product ID
51206-311_5b14ee76-2fcb-639e-e063-6294a90a9211
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
2023-11-19
Marketing end
2029-10-15
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
Opal by Opalescence Sensitivity

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
5ffc0d14-0290-47bb-90e5-90a25a5acc28Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
51206-311-01Opal™ by Opalescence ® Sensitivity
51206-311-01Opal™ by Opalescence ® Sensitivity
51206-311-02Opal™ by Opalescence ® Sensitivity
51206-311-02Opal™ by Opalescence ® Sensitivity

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-311-01Opal by Opalescence Sensitivity1 in 1 CARTONGEL, DENTIFRICE15
51206-311-01Opal by Opalescence Sensitivity133 g in 1 TUBEGEL, DENTIFRICE1335
51206-311-02Opal by Opalescence Sensitivity1 in 1 CARTONGEL, DENTIFRICE15
51206-311-02Opal by Opalescence Sensitivity3 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-311OPAL BY OPALESCENCE SENSITIVITY (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]4Current NDC, 4 package rows20250402_5ffc0d14-0290-47bb-90e5-90a25a5acc28.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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Breath Purify and Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd71ed31f-cc33-2fc3-e053-2995a90ad39b2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health ClinicalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company0a295ee0-55c2-4f21-8f0a-70efc0e516942026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd721e2cb-8f67-3d07-e053-2995a90ae65a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health AdvantageCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyddcd56fe-25d6-8195-e053-2a95a90a575a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dc1f31-625d-a032-e053-2995a90a730d2026-01-08WarningsExact identifier
application number: M022
Crest Pro Health Gum plus Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc598a4ab-5981-0068-e053-2a95a90af4fa2026-01-08WarningsExact identifier
application number: M022
Oral B Gum Detoxify Special Care RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dcdde4-5542-1f87-e053-2995a90a261c2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Fresh MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company62991165-ec81-48a8-e053-2991aa0a54f32026-01-08WarningsExact identifier
application number: M022
Crest Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company72f1a02f-1d02-7e83-e053-2a91aa0a79472026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company6287bc3e-8b05-45d3-e053-2991aa0aaa102026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company8867d791-7e93-4f39-aaaf-bfbee8296fd92026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLC387d264c-90cc-5e67-e063-6394a90a713d2026-01-08WarningsExact identifier
application number: M022
TopCare Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDETOPCO Assoc. LLC835f41cf-e920-7df7-e053-2a91aa0a44792026-01-08WarningsExact identifier
application number: M022
Scope Icy BlastCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company164ed151-01d3-021a-e063-6294a90a0e512026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Advanced Enamel CareSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1660e7d7-5b8d-8aba-e063-6294a90a50d82026-01-08WarningsExact identifier
application number: M022
Crest Deep Cleanse Germ TreatmentCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company2d6b15d4-7827-ec2f-e063-6294a90a82c82026-01-08WarningsExact identifier
application number: M022
Crest Scope OriginalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company21eed451-9368-146c-e063-6294a90af62b2026-01-08WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
HEB Extra WhiteningFLUORIDEHEBb76c3591-6383-4661-b3db-7a56b11202f72026-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN5ffc0d14-0290-47bb-90e5-90a25a5acc285
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD5ffc0d14-0290-47bb-90e5-90a25a5acc285
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY5ffc0d14-0290-47bb-90e5-90a25a5acc285
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY5ffc0d14-0290-47bb-90e5-90a25a5acc285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-311-01512060311011 TUBE in 1 CARTON (51206-311-01) / 133 g in 1 TUBE1 tube2023-11-192029-10-15NoNoHistorical
51206-311-02512060311023 CARTON in 1 PACKAGE, COMBINATION (51206-311-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE3 carton2023-11-192029-10-15NoNoHistorical