Home NDC 0135-0579 Sensodyne
Product NDC 0135-0579
11-digit product format 001350579
Labeler code 0135
Product ID 0135-0579_13132a2c-ad64-186a-e063-6394a90add7e
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate and sodium fluoride
Dosage form PASTE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-12-21
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
Brand name suffix True white
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.15 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038841 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0579-01 SensodyneTrue white 1 in 1 CARTON PASTE 1 5 0135-0579-01 SensodyneTrue white 85 g in 1 TUBE PASTE 85 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0579 SENSODYNE TRUE WHITE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240308_671f8f45-389c-4375-be43-f5500ee21a0e.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 16 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GuruNanda Oxyfusion HYDROGEN PEROXIDE GURUNANDA, LLC 3be317b9-a5d8-b198-e063-6394a90af985 2025-11-11 Warnings Exact identifier application number: M022 GuruNanda Oral Pain Relief MENTHOL GURUNANDA, LLC 3b8f3562-0e46-bea4-e063-6294a90adb71 2025-11-11 Warnings Exact identifier application number: M022 TopCare Cherry Flavor PHENOL TOPCO ASSOCIATES, LLC 5d3f0610-deb4-4180-ae19-2c65ed2f368b 2025-11-10 Warnings Exact identifier application number: M022 Topcare Sore Throat Menthol Flavor PHENOL TOPCO ASSOCIATES LLC fb1f2c11-2508-4985-bae5-7d547bd6aa23 2025-11-10 Warnings Exact identifier application number: M022 Zilactin-B BENZOCAINE ASCENT CONSUMER PRODUCTS, INC 42eeb3d4-bac6-4e29-e063-6294a90a644d 2025-11-06 Warnings Exact identifier application number: M022 Zilactin Early Relief Cold Sore BENZYL ALCOHOL ASCENT CONSUMER PRODUCTS, INC 42ef8bfa-c4d9-01cf-e063-6394a90ac88a 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 106b6115-d043-4050-80c6-1d82456dea02 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 4c278122-2643-46bf-9e44-11985210a16e 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC fee9969d-ad1a-4f44-9741-a0a44c9e1128 2025-11-06 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE Target Corporation 0ddf9945-147d-4b25-98a6-4e9f12a4656f 2025-11-05 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. e6a312e5-17ac-46f0-8723-4e40eeecd69f 2025-11-04 Warnings Exact identifier application number: M022 PEROXY SHIELD MOUTH SORE 1.5% HYDROGEN PEROXIDE Dental Technologies, Inc. a72e433b-1b7d-4a0c-e053-2995a90a30c4 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ae628766-25b7-4b4f-abb8-a43faf2f44b9 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. 719743f9-21fc-4568-b879-acdfa4639464 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ff0695a1-1d7d-4b51-97fd-689e56d914fe 2025-11-04 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Family Dollar (FAMILY WELLNESS) f7edf75c-cdba-4dde-bfc5-a04af34759d3 2025-11-03 Warnings Exact identifier application number: M022 7 Select Oral Pain Maximum Strength Relief BENZOCAINE 7-ELEVEN, INC. f170a570-1c50-4b9a-be16-9b01bf5eaa74 2025-10-31 Warnings Exact identifier application number: M022 Oral Pain Relief BENZOCAINE AND BENZALKONIUM CHLORIDE Universal Distribution Center LLC 18520f9b-4d35-1e9c-e063-6294a90aaa39 2025-10-30 Warnings Exact identifier application number: M022 Iodent Oral Analgesic BENZOCAINE United Exchange Corp. 63902125-f8dc-0ada-e053-2991aa0a7ce5 2025-10-30 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE BETTER LIVING BRANDS, LLC 3bded237-4d2c-4b38-bedc-267fdc374194 2025-10-29 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0135-0579-01 00135057901 1 TUBE in 1 CARTON (0135-0579-01) / 85 g in 1 TUBE 1 tube 2015-12-21 0000-00-00 No No Current