FDA.reportPublic FDA data

equate Sensitive

Product NDC
49035-257
11-digit product format
490350257
Labeler code
49035
Product ID
49035-257_47e562a2-d35f-fddb-e063-6394a90a2717
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Wal-Mart Stores Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-02
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
equate Sensitive
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-257-792020-06-26C16284748780-19d75b9d1-242d-f424-e053-dadaa90a57ce5820257 Equate Sensitive Toothpaste with Fluoride
49035-257-792020-06-26C16284748780-19d75b9d1-242d-f424-e053-dadaa90a57ce5820257 Equate Sensitive Toothpaste with Fluoride
49035-257-792020-01-31C16284748780-19d75b9d1-242d-f424-e053-dadaa90a57ce5820257 Equate Sensitive Toothpaste with Fluoride
49035-257-792020-01-31C16284748780-19d75b9d1-242d-f424-e053-dadaa90a57ce5820257 Equate Sensitive Toothpaste with Fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-257-29equate Sensitive1 in 1 CARTONPASTE, DENTIFRICE19
49035-257-29equate Sensitive2 in 1 PACKAGEPASTE, DENTIFRICE29
49035-257-79equate Sensitive1 in 1 BOXPASTE, DENTIFRICE19
49035-257-79equate Sensitive113 g in 1 TUBEPASTE, DENTIFRICE1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-257EQUATE SENSITIVE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [WAL-MART STORES INC]7Current NDC, Legacy NDC, 4 package rows20250315_79899b59-3a16-6504-e053-2991aa0a895a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD79899b59-3a16-6504-e053-2991aa0a895a9
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-257-29490350257292 CARTON in 1 PACKAGE (49035-257-29) / 1 TUBE in 1 CARTON / 113 g in 1 TUBE2 carton2018-11-020000-00-00NoNoCurrent
49035-257-79490350257791 TUBE in 1 BOX (49035-257-79) / 113 g in 1 TUBE1 tube2018-11-020000-00-00NoNoCurrent