Opalescence Sensitivity Relief Whitening

Product NDC
51206-451
11-digit product format
512060451
Labeler code
51206
Product ID
51206-451_5d5c2b00-d33f-797b-e063-6294a90aefea
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
2026-07-16
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

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

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 29 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BencoCaine Topical AnestheticBENZOCAINEBenco Dental3cc5d095-5f9c-4e4d-8971-0079e949b7ca2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89d23b14-398e-4b3e-955a-724ff66579b92025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentale381b2d5-6485-4d11-94f4-eec335d5cf412025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental8ffc4af6-d99c-4964-8d7d-4644bc699a3d2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05e31aaa-a932-f48b-e063-6394a90af32e2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05e31aaa-a934-f48b-e063-6394a90af32e2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9236161b-a427-6efa-e053-2a95a90a99c42025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9224ecb4-c58f-ae7d-e053-2995a90ac2ed2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.923614c5-d1bf-b444-e053-2995a90aa5c62025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9235cb3f-a45b-10e5-e053-2995a90ae5e32025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.923636fb-8f9a-480b-e053-2995a90a618e2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9235fd71-3dd9-436a-e053-2995a90af7ec2025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3fe5283f-967b-4f57-941b-ab80ea40ce502025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental4860dc44-6811-4db5-aeda-05fac830b1882025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental7619d53c-3f6e-4041-93a1-df33d5f9e3f72025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentalb2cd6d74-b35a-4cc1-8752-519bce9047372025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentala948c5a7-d431-4f46-bb59-8974924e63202025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental18d2e370-b30e-4b50-85d8-265964be2dde2025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3eb3bbc6-07d4-44c5-adac-701db06f9cd82025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentalfcfcece3-ee81-4275-82e2-aba93a6862ee2025-01-08WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51206-451-01512060451011 TUBE in 1 CARTON (51206-451-01) / 133 g in 1 TUBE1 tube2026-07-16NoNoCurrent
51206-451-025120604510212 CARTON in 1 PACKAGE, COMBINATION (51206-451-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE12 carton2026-07-16NoNoCurrent
51206-451-03512060451031 TUBE in 1 CARTON (51206-451-03) / 28.35 g in 1 TUBE1 tube2026-07-16NoNoCurrent
51206-451-045120604510424 CARTON in 1 PACKAGE, COMBINATION (51206-451-04) / 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE24 carton2026-07-16NoNoCurrent
51206-451-055120604510548 TUBE in 1 PACKAGE, COMBINATION (51206-451-05) / 28.35 g in 1 TUBE48 tube2026-07-16NoNoCurrent