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
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

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

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