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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086243Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2f9d58b-671b-4427-a971-1fceff5f2323Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHLO PRO Healthy GumsCETYLPYRIDINIUM CHLORIDEGervest USA Inc4f5a0ccb-26e5-ebb6-e063-6394a90abbc52026-04-13WarningsExact identifier
application number: M022
Crest Scope Original Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f1db6f4-acd7-a665-e063-6294a90a826b2026-04-10WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
application number: M022
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)269b9e7f-c5c8-4023-a3ea-e39040ade2712026-04-06WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea2026-04-01WarningsExact identifier
application number: M022
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsExact identifier
application number: M022
Crest Pro-Health Bold Fresh BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company5692c0ce-a914-08c4-e063-6394a90adf152026-04-01WarningsExact identifier
application number: M022
Anticavity FluorideSODIUM FLUORIDE AND ACIDULATED PHOSPHATEFamily Dollar (FAMILY WELLNESS)1666fff6-9a8b-40f9-ae53-914152db386b2026-04-01WarningsExact identifier
application number: M022
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
application number: M022
Sootheez Birthday CakePECTINPrimrose Candy Co.4e5d8234-0521-0c8a-e063-6294a90ae62d2026-03-31WarningsExact identifier
application number: M022
Sootheez Watermelon MintPECTINPrimrose Candy Co.4e5e4342-4647-ef25-e063-6394a90a1d132026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC4e5a67a0-f989-50df-e063-6394a90aae732026-03-31WarningsExact identifier
application number: M022
PeriogelHYDROGEN PEROXIDEPERIO PROTECT, LLC1f9686b1-eac2-65b7-e063-6394a90a74fb2026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC1f7ecd75-bb59-2f4f-e063-6294a90ace842026-03-31WarningsExact identifier
application number: M022
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corped63df26-3879-46df-8e09-10be569b25be2026-03-31WarningsExact identifier
application number: M022
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
application number: M022
Kroger Extra WhiteningFLUORIDEKrogere704c690-1383-4cd6-be85-28bdd9ff936b2026-03-24WarningsExact identifier
application number: M022

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