FDA.reportPublic FDA data

SENSODYNE PRONAMEL

Product NDC
0135-0484
11-digit product format
001350484
Labeler code
0135
Product ID
0135-0484_0fb8d5cd-17d5-f0ac-e063-6394a90ab28d
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate and sodium fluoride
Dosage form
PASTE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-10-18
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 PRONAMEL
Brand name suffix
Gentle Whitening
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0484-01SENSODYNE PRONAMELGentle Whitening113 g in 1 TUBEPASTE11321
0135-0484-01SENSODYNE PRONAMELGentle Whitening1 in 1 CARTONPASTE121
0135-0484-02SENSODYNE PRONAMELGentle Whitening1 in 1 CARTONPASTE121
0135-0484-02SENSODYNE PRONAMELGentle Whitening76.5 g in 1 TUBEPASTE76.521
0135-0484-03SENSODYNE PRONAMELGentle Whitening22.6 g in 1 TUBEPASTE22.621
0135-0484-04SENSODYNE PRONAMELGentle Whitening184.3 g in 1 TUBEPASTE184.321
0135-0484-04SENSODYNE PRONAMELGentle Whitening1 in 1 CARTONPASTE121
0135-0484-05SENSODYNE PRONAMELGentle Whitening2 in 1 CARTONPASTE221
0135-0484-05SENSODYNE PRONAMELGentle Whitening113 g in 1 TUBEPASTE11321
0135-0484-06SENSODYNE PRONAMELGentle Whitening4 in 1 CARTONPASTE421
0135-0484-06SENSODYNE PRONAMELGentle Whitening184.3 g in 1 TUBEPASTE184.321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0484SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 11 package rows20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNedffce4d-108b-4ffd-9adf-e12cb42ffddd21
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDedffce4d-108b-4ffd-9adf-e12cb42ffddd21
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYedffce4d-108b-4ffd-9adf-e12cb42ffddd21
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYedffce4d-108b-4ffd-9adf-e12cb42ffddd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0484-01001350484011 TUBE in 1 CARTON (0135-0484-01) / 113 g in 1 TUBE1 tube2010-10-180000-00-00NoNoCurrent
0135-0484-02001350484021 TUBE in 1 CARTON (0135-0484-02) / 76.5 g in 1 TUBE1 tube2010-10-180000-00-00NoNoCurrent
0135-0484-030013504840322.6 g in 1 TUBE (0135-0484-03) 22.6 g2010-10-180000-00-00NoNoCurrent
0135-0484-04001350484041 TUBE in 1 CARTON (0135-0484-04) / 184.3 g in 1 TUBE1 tube2019-07-010000-00-00NoNoCurrent
0135-0484-05001350484052 TUBE in 1 CARTON (0135-0484-05) / 113 g in 1 TUBE2 tube2010-10-180000-00-00NoNoCurrent
0135-0484-06001350484064 TUBE in 1 CARTON (0135-0484-06) / 184.3 g in 1 TUBE4 tube2014-12-160000-00-00NoNoCurrent