FDA.reportPublic FDA data

sensodyne

Product NDC
0135-0593
11-digit product format
001350593
Labeler code
0135
Product ID
0135-0593_185979b0-b621-c0ea-e063-6394a90a2312
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate and sodium fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-12-19
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.15 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sensodyne
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.15 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1086243

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0593-01sensodyne113 g in 1 TUBEPASTE1138
0135-0593-01sensodyne1 in 1 CARTONPASTE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0593-01GM - Gram0135-0593b9f6f245-3a6b-4662-aacb-10d5015ec2dc12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0593SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 2 package rows20240514_16225f06-1d40-416a-aaec-7890e398fe4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN16225f06-1d40-416a-aaec-7890e398fe4b8
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD16225f06-1d40-416a-aaec-7890e398fe4b8
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY16225f06-1d40-416a-aaec-7890e398fe4b8
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY16225f06-1d40-416a-aaec-7890e398fe4b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0593-01001350593011 TUBE in 1 CARTON (0135-0593-01) / 113 g in 1 TUBE1 tube2016-12-190000-00-00NoNoCurrent
0135-0593-02001350593021 TUBE in 1 CARTON (0135-0593-02) > 23 g in 1 TUBE1 tube2016-12-190000-00-00NoNoCurrent