FDA.reportPublic FDA data

Sensodyne Pronamel

Product NDC
0135-0602
11-digit product format
001350602
Labeler code
0135
Product ID
0135-0602_13097a10-0813-22b5-e063-6294a90a9317
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
2016-12-19
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

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
Strong and Bright Enamel Mint
Listing expiration
2026-12-31

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
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal 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
be1ae382-0e01-4db8-90d7-fdadec2ff861Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0602-01Sensodyne PronamelStrong and Bright Enamel Mint1 in 1 CARTONPASTE14
0135-0602-01Sensodyne PronamelStrong and Bright Enamel Mint85 g in 1 TUBEPASTE854
0135-0602-02Sensodyne PronamelStrong and Bright Enamel Mint23 g in 1 TUBEPASTE234
0135-0602-02Sensodyne PronamelStrong and Bright Enamel Mint1 in 1 CARTONPASTE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0602-01GM - Gram0135-06027cc7805a-d7bf-42c4-9389-bcc89db44ba512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0602SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 4 package rows20240308_be1ae382-0e01-4db8-90d7-fdadec2ff861.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 12 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Whitening Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.c25b6a95-e604-48e3-bc55-595969d1ce9b2025-12-23WarningsExact identifier
application number: M022
parodontax Active Gum RepairSTANNOUS FLUORIDEHaleon US Holdings LLCb51ccdd9-c0af-4caa-ad97-ad1d1423b76b2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLC59bb84d6-6fd3-4586-bccf-7dc45cbbb39c2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLCf6912712-ce9b-44aa-8953-b9a8d420f4582025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair WhiteningSTANNOUS FLUORIDEHaleon US Holdings LLC817e804c-e55e-4d77-9ab9-ff54ae7947252025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair Breath FreshenerSTANNOUS FLUORIDEHaleon US Holdings LLCaddcb1e2-24b9-4367-adf3-6806e2439a802025-12-22WarningsExact identifier
application number: M022
parodontaxSTANNOUS FLUORIDEHaleon US Holdings LLC0f07aa1a-97be-44af-92d8-a10777e24e0a2025-12-22WarningsExact identifier
application number: M022
R B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.410c40fd-cf94-0301-e063-6294a90ae2de2025-12-18WarningsExact identifier
application number: M022
Dem ZeroPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.411f1a0f-ed02-cc78-e063-6394a90a0aec2025-12-18WarningsExact identifier
application number: M022
Res B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.21469f58-1d70-774f-e063-6294a90af0392025-12-18WarningsExact identifier
application number: M022
Alzh LPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.41056de0-aaa2-01bb-e063-6394a90af7b82025-12-18WarningsExact identifier
application number: M022
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
application number: M022
CloSYSHYDROGEN PEROXIDERowpar Pharmaceuticals, Inc.299fc7b1-af6d-4bf9-810f-d35283423fe22025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.c13761e0-d45d-4e0f-ac41-428e005f96bb2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.6dca566b-cb6a-43c4-b6e2-f2bad77fb9322025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.7ede08e5-2dfe-4183-905d-28d1cea424072025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.9de36e4f-f966-4a58-b4bf-9ac3b86b3f092025-12-17WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDECVS PHARMACY, INC3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb22025-12-17WarningsExact identifier
application number: M022
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNbe1ae382-0e01-4db8-90d7-fdadec2ff8614
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDbe1ae382-0e01-4db8-90d7-fdadec2ff8614
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYbe1ae382-0e01-4db8-90d7-fdadec2ff8614
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYbe1ae382-0e01-4db8-90d7-fdadec2ff8614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0602-01001350602011 TUBE in 1 CARTON (0135-0602-01) / 85 g in 1 TUBE1 tube2016-12-190000-00-00NoNoCurrent
0135-0602-02001350602021 TUBE in 1 CARTON (0135-0602-02) / 23 g in 1 TUBE1 tube2016-12-190000-00-00NoNoCurrent