FDA.reportPublic FDA data

SENSODYNE PRONAMEL

Product NDC
0135-0481
11-digit product format
001350481
Labeler code
0135
Product ID
0135-0481_4c9ab9d6-fc06-eea3-e063-6394a90a5939
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
2020-01-06
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.15 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SENSODYNE PRONAMEL
Brand name suffix
Intensive Enamel Repair Whitening
Listing expiration
2027-12-31

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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0481-01SENSODYNE PRONAMELIntensive Enamel Repair Whitening1 in 1 CARTONPASTE110
0135-0481-01SENSODYNE PRONAMELIntensive Enamel Repair Whitening96.4 g in 1 TUBEPASTE96.410
0135-0481-02SENSODYNE PRONAMELIntensive Enamel Repair Whitening96.4 g in 1 TUBEPASTE96.410
0135-0481-02SENSODYNE PRONAMELIntensive Enamel Repair Whitening2 in 1 CARTONPASTE210
0135-0481-04SENSODYNE PRONAMELIntensive Enamel Repair Whitening65 g in 1 TUBEPASTE6510
0135-0481-04SENSODYNE PRONAMELIntensive Enamel Repair Whitening1 in 1 CARTONPASTE110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0481SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR CLEAN MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR EXTRA FRESH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 6 package rows20240410_a2f9d58b-671b-4427-a971-1fceff5f2323.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNa2f9d58b-671b-4427-a971-1fceff5f232310
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDa2f9d58b-671b-4427-a971-1fceff5f232310
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYa2f9d58b-671b-4427-a971-1fceff5f232310
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYa2f9d58b-671b-4427-a971-1fceff5f232310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0481-01001350481011 TUBE in 1 CARTON (0135-0481-01) / 96.4 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent
0135-0481-02001350481022 TUBE in 1 CARTON (0135-0481-02) / 96.4 g in 1 TUBE2 tube2020-01-060000-00-00NoNoCurrent
0135-0481-04001350481041 TUBE in 1 CARTON (0135-0481-04) / 65 g in 1 TUBE1 tube2025-12-01NoNoCurrent