Home NDC 0135-0528-04 Sensodyne
Product NDC 0135-0528
Requested package NDC 0135-0528-04
11-digit product format 001350528
Labeler code 0135
Product ID 0135-0528_38529353-3b28-4a02-b2d7-54209276fc78
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate and sodium fluoride
Dosage form PASTE
Route DENTAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2000-07-01
Marketing end 0000-00-00
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50 mg/g; mg/g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0528-04 SensodyneFresh Impact 1 in 1 CARTON PASTE 1 19 0135-0528-04 SensodyneFresh Impact 113 g in 1 TUBE PASTE 113 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0528 SENSODYNE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE FRESH IMPACT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 19 Legacy NDC, 2 package rows 20240517_1ed4a62b-f1d3-4740-8150-b94e02398740.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 1 of 1 · 1 matching rows.
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 0135-0528-04 00135052804 1 TUBE in 1 CARTON (0135-0528-04) > 113 g in 1 TUBE 1 tube 2000-07-01 0000-00-00 No No Current