FDA.reportPublic FDA data

TopCare Sensitive

Product NDC
36800-451
11-digit product format
368000451
Labeler code
36800
Product ID
36800-451_47e517a4-25d4-4a28-e063-6294a90a3453
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
TOPCO Assoc. LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-20
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
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
TopCare Sensitive
Brand name suffix
Extra Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 g/100g

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
835f41cf-e920-7df7-e053-2a91aa0a4479Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-451-59TopCare SensitiveExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE114
36800-451-59TopCare SensitiveExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE11314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-451TOPCARE SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]12Current NDC, Legacy NDC, 2 package rows20250119_835f41cf-e920-7df7-e053-2a91aa0a4479.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 3 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact identifier
application number: M022
Freshness Coffee Toothpaste100gFRESHNESS COFFEE TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d79e9-2f0f-fa72-e063-6394a90a8dea2026-08-06WarningsExact identifier
application number: M022
Freshness Flower Rose Toothpaste100gFRESHNESS FLOWER ROSE TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d7f5e-55e0-4fd2-e063-6294a90a92b62026-08-06WarningsExact identifier
application number: M022
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
application number: M022
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
application number: M022
Dental system starter kitUS CONVENIENCE KIT (718907)Dyson Technology Limited5355b79b-711f-1a4a-e063-6394a90afc4b2026-06-30WarningsExact identifier
application number: M022
Anticavity and sensitive peppermint907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINTDyson Technology Limited5332ab71-d994-39cf-e063-6294a90a0d982026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
application number: M022
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
application number: M022
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact identifier
application number: M022
GingiCaine gel, CherryGINGICAINE GEL, CHERRY FLAVORGingi-Pak a Division of the Belport6274d92e-c4e9-34fd-e053-2991aa0ae6042026-06-29WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN835f41cf-e920-7df7-e053-2a91aa0a447914
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD835f41cf-e920-7df7-e053-2a91aa0a447914
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY835f41cf-e920-7df7-e053-2a91aa0a447914
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY835f41cf-e920-7df7-e053-2a91aa0a447914
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY835f41cf-e920-7df7-e053-2a91aa0a447914
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY835f41cf-e920-7df7-e053-2a91aa0a447914
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY835f41cf-e920-7df7-e053-2a91aa0a447914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-451-59368000451591 TUBE in 1 CARTON (36800-451-59) / 113 g in 1 TUBE1 tube2011-01-200000-00-00NoNoCurrent