FDA.reportPublic FDA data

Sound Body Sensitive

Product NDC
50594-214
11-digit product format
505940214
Labeler code
50594
Product ID
50594-214_43958162-cac7-a219-e063-6294a90ac0aa
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Big Lots Stores, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-05
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sound Body Sensitive
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50594-214-192024-02-23C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)
50594-214-192020-09-27C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)
50594-214-192020-09-25C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)
50594-214-192020-07-22C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50594-214-19Sound Body SensitiveMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1135
50594-214-19Sound Body SensitiveMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-214SOUND BODY SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BIG LOTS STORES, INC.]3Current NDC, Legacy NDC, 2 package rows20250119_81a0a712-76e1-133f-e053-2a91aa0a001a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN81a0a712-76e1-133f-e053-2a91aa0a001a5
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD81a0a712-76e1-133f-e053-2a91aa0a001a5
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY81a0a712-76e1-133f-e053-2a91aa0a001a5
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY81a0a712-76e1-133f-e053-2a91aa0a001a5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY81a0a712-76e1-133f-e053-2a91aa0a001a5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY81a0a712-76e1-133f-e053-2a91aa0a001a5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY81a0a712-76e1-133f-e053-2a91aa0a001a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50594-214-19505940214191 TUBE in 1 CARTON (50594-214-19) / 113 g in 1 TUBE1 tube2014-03-05NoNoCurrent