FDA.reportPublic FDA data

SENSODYNE PRONAMEL

Product NDC
0135-0480
Requested package NDC
0135-0480-01
11-digit product format
001350480
Labeler code
0135
Product ID
0135-0480_b6b53ab0-82ee-459a-be1a-14e12c2582f5
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate and sodium fluoride
Dosage form
PASTE
Route
ORAL
Labeler
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-04
Marketing end
0000-00-00
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0135-04800135-0480-01DDiscontinued by firm2026-10-20

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0480-01SENSODYNE PRONAMELmineral BOOST whitening action118 g in 1 TUBEPASTE1182
0135-0480-01SENSODYNE PRONAMELmineral BOOST whitening action1 in 1 CARTONPASTE12
0135-0480-02SENSODYNE PRONAMELmineral BOOST whitening action1 in 1 CARTONPASTE12
0135-0480-02SENSODYNE PRONAMELmineral BOOST whitening action77 g in 1 TUBEPASTE772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0480SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]2Legacy NDC, 4 package rows20240306_b6b53ab0-82ee-459a-be1a-14e12c2582f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNb6b53ab0-82ee-459a-be1a-14e12c2582f52
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDb6b53ab0-82ee-459a-be1a-14e12c2582f52
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYb6b53ab0-82ee-459a-be1a-14e12c2582f52
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYb6b53ab0-82ee-459a-be1a-14e12c2582f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0480-01001350480011 TUBE in 1 CARTON (0135-0480-01) > 118 g in 1 TUBE1 tube2021-01-040000-00-00NoNoCurrent