Sensodyne
- Product NDC
- 0135-0551
- Requested package NDC
- 0135-0551-04
- 11-digit product format
- 001350551
- Labeler code
- 0135
- Product ID
- 0135-0551_84202ac9-7804-4e03-bf5e-1715c3b611f9
- 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
- 2002-01-02
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0135-0551 | 0135-0551-04 | D | Discontinued by firm | 2026-10-05 |
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.
| 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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0551-04 | Sensodyne | 1 in 1 CARTON | PASTE | 1 | 10 | |
| 0135-0551-04 | Sensodyne | 113 g in 1 TUBE | PASTE | 113 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 2024-05-15 | Warnings | 0135-0551-04 0135-0551 00135055104 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1038841 | potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste | PSN | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 10 |
| 1038841 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG Toothpaste | SCD | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 10 |
| 1038841 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste | SY | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 10 |
| 1038841 | pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel Toothpaste | SY | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 10 |
| 1038841 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste | SY | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 10 |
| 1038841 | potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste | SY | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0551-04 | 00135055104 | 1 TUBE in 1 CARTON (0135-0551-04) > 113 g in 1 TUBE | 1 tube | 2002-01-02 | 0000-00-00 | No | No | Current |