Home NDC 0135-0579-01 Sensodyne
Product NDC 0135-0579
Requested package NDC 0135-0579-01
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 RU45X2JN0Z Internal UNII lookup 8ZYQ1474W7 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 31 of 39 · 779 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Topicale BENZOCAINE Medical Products Laboratories, Inc. 8282a4a6-b77c-75fc-e053-2991aa0ad4ac 2024-12-16 Warnings Exact identifier application number: M022 Topicale Xtra BENZOCAINE Medical Products Laboratories,Inc. 9452bff4-8c08-eff9-e053-2a95a90a67ed 2024-12-16 Warnings Exact identifier application number: M022 PHENOL PHENOL CHAIN DRUG MARKETING ASSOCIATION INC. 2379e23a-72fe-4e94-9d7e-9b623c0db174 2024-12-13 Warnings Exact identifier application number: M022 KANKA SoftBrush BENZOCAINE AND ZINC CHLORIDE Blistex Inc 093f3545-1d8e-48a3-a533-e9c3ae6d740b 2024-12-12 Warnings Exact identifier application number: M022 Topicale BENZOCAINE Medical Products Laboratories, Inc. 826eaef8-4457-3dc2-e053-2991aa0a528b 2024-12-11 Warnings Exact identifier application number: M022 Topicale BENZOCAINE Medical Products Laboratories, Inc. 8281700c-10f9-841c-e053-2991aa0a918f 2024-12-11 Warnings Exact identifier application number: M022 Topicale BENZOCAINE Medical Products Laboratories, Inc. 82824416-80de-76bd-e053-2a91aa0ad8b5 2024-12-11 Warnings Exact identifier application number: M022 Topicale Xtra BENZOCAINE Medical Products Laboratories,Inc. e3da0e63-a891-72bd-e053-2a95a90a58bc 2024-12-11 Warnings Exact identifier application number: M022 Topicale Xtra BENZOCAINE Medical Products Laboratories, Inc. e3d924b5-0788-46d3-e053-2995a90a027b 2024-12-11 Warnings Exact identifier application number: M022 Fluoride Bits SODIUM MONOFLUOROPHOSPHATE 0.76% The Kind Lab, Inc. fa433031-7376-0e5b-e053-6394a90a5f75 2024-12-11 Warnings Exact identifier application number: M022 Fluoride Bits SODIUM MONOFLUOROPHOSPHATE 0.76% The Kind Lab, Inc. eedf13dc-a009-027a-e053-2995a90a8ec8 2024-12-11 Warnings Exact identifier application number: M022 NATURAL LEMON MINT HERB THROAT DROPS MENTHOL Ricola USA Inc. 763e8234-60be-4b1f-9f78-01c574f35d0a 2024-12-10 Warnings Exact identifier application number: M022 Natural Cherry Honey Herb Throat Drops MENTHOL Ricola USA Inc. 989f8509-cd28-48e7-9aa1-baddfbcac95a 2024-12-10 Warnings Exact identifier application number: M022 ORGANIC PEPPERMINT HERB THROAT DROPS MENTHOL Ricola USA Inc. f75c8967-40e6-473a-b403-941354cb0be1 2024-12-10 Warnings Exact identifier application number: M022 Natural Cherry Honey Herb Throat Drops MENTHOL Ricola USA Inc. c56be34d-1dd5-4200-9723-3a73180cb759 2024-12-10 Warnings Exact identifier application number: M022 Cherry Throat Drops MENTHOL Ricola USA Inc. 89257ceb-af0f-4516-88f7-6dfdab9e14f4 2024-12-10 Warnings Exact identifier application number: M022 BERRY MEDLEY THROAT DROPS MENTHOL Ricola USA Inc. 9bfd2ea7-745b-47f8-bd8a-9dbeeaad8b95 2024-12-10 Warnings Exact identifier application number: M022 NATURAL LEMON MINT HERB THROAT DROPS MENTHOL Ricola USA Inc. 6a81e5c7-834d-44da-853f-8f6103236311 2024-12-10 Warnings Exact identifier application number: M022 SUGAR FREE SWISS CHERRY HERB THROAT DROPS MENTHOL Ricola USA Inc. 8a24f614-8e21-4ab2-8c0e-6af947911ccd 2024-12-10 Warnings Exact identifier application number: M022 RICOLA MAX NASAL CARE COOL MENTHOL MENTHOL Ricola USA Inc. a2e189a2-65ae-48a9-99ad-8795334082df 2024-12-10 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