Sensodyne

Product NDC
0135-0529
11-digit product format
001350529
Labeler code
0135
Product ID
0135-0529_18835f57-a509-2ac6-e063-6394a90a8aaf
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
1990-09-30
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
Brand name suffix
Fresh Mint
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
Rxcui1038841, 1038929, 1086243

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
0135-0529-01SensodyneFresh Mint1 in 1 CARTONPASTE119
0135-0529-01SensodyneFresh Mint23 g in 1 TUBEPASTE2319
0135-0529-03SensodyneFresh Mint2 in 1 CARTONPASTE219
0135-0529-03SensodyneFresh Mint113 g in 1 TUBEPASTE11319
0135-0529-04SensodyneFresh Mint1 in 1 CARTONPASTE119
0135-0529-04SensodyneFresh Mint113 g in 1 TUBEPASTE11319
0135-0529-05SensodyneFresh Mint1 in 1 CARTONPASTE119
0135-0529-05SensodyneFresh Mint77 g in 1 TUBEPASTE7719
0135-0529-10SensodyneFresh Mint23 g in 1 TUBEPASTE2319

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0529-04GM - Gram0135-052918df28d2-9f7e-4074-b173-03447ae2920912020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7SENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
NITRATE IONACTIVE MOIETYT93E9Y2844SENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9SENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SORBITOLINACTIVE INGREDIENT506T60A25RSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
WATERINACTIVE INGREDIENT059QF0KO0RSENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESENSODYNE COOLGEL (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE ORIGINAL FLAVOR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0529SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]19Current NDC, Legacy NDC, 9 package rows20240517_1ed4a62b-f1d3-4740-8150-b94e02398740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpastePSN1ed4a62b-f1d3-4740-8150-b94e0239874019
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN1ed4a62b-f1d3-4740-8150-b94e0239874019
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN1ed4a62b-f1d3-4740-8150-b94e0239874019
1038841potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG ToothpasteSCD1ed4a62b-f1d3-4740-8150-b94e0239874019
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD1ed4a62b-f1d3-4740-8150-b94e0239874019
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD1ed4a62b-f1d3-4740-8150-b94e0239874019
1038841K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038841pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038841Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY1ed4a62b-f1d3-4740-8150-b94e0239874019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0529-01001350529011 TUBE in 1 CARTON (0135-0529-01) / 23 g in 1 TUBE1 tube2019-01-140000-00-00NoNoCurrent
0135-0529-03001350529032 TUBE in 1 CARTON (0135-0529-03) / 113 g in 1 TUBE2 tube2014-12-160000-00-00NoNoCurrent
0135-0529-04001350529041 TUBE in 1 CARTON (0135-0529-04) / 113 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent
0135-0529-05001350529051 TUBE in 1 CARTON (0135-0529-05) / 77 g in 1 TUBE1 tube1990-09-300000-00-00NoNoCurrent
0135-0529-100013505291023 g in 1 TUBE (0135-0529-10) 23 g2023-01-020000-00-00NoNoCurrent