Exceed Total Care Sensitive
- Product NDC
- 54473-337
- 11-digit product format
- 544730337
- Labeler code
- 54473
- Product ID
- 54473-337_4746b4ab-584f-7572-e063-6394a90a971d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Potassium Nitrate and Sodium Fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- TOPICAL
- Labeler
- Melaleuca, Inc
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-01-08
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- .2272; 4.675 g/93.5g; g/93.5g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 54473-337-04 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 54473-337-04 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 54473-337-04 | 1332a3947898… | d4bfe170f9cd… |
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
- Exceed Total Care Sensitive
- Brand name suffix
- Spearmint Tooth Polish
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM NITRATE | .2272 g/93.5g |
| SODIUM FLUORIDE | 4.675 g/93.5g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RU45X2JN0Z | Internal UNII lookup |
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dc620d3f-880f-df05-e053-2995a90a8409 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54473-337-04 | 2024-05-28 | C162847 | 48780-1 | 1030e365-3e7c-111a-e063-dadaa90a10e2 | Exceed Total Care Sensitive Tooth Polish - Spearmint |
| 54473-337-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3e7c-111a-e063-dadaa90a10e2 | Exceed Total Care Sensitive Tooth Polish - Spearmint |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54473-337-04 | Exceed Total Care SensitiveSpearmint Tooth Polish | 93.5 g in 1 TUBE | PASTE, DENTIFRICE | 93.5 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54473-337 | EXCEED TOTAL CARE SENSITIVE SPEARMINT TOOTH POLISH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [MELALEUCA, INC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240529_dc620d3f-880f-df05-e053-2995a90a8409.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| United Airlines Therabody Polaris Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | ab667740-55ab-470e-9514-163961502ceb | 2023-10-26 | Warnings | M021 |
| Cavity Protection Fresh Mint | SODIUM FLUORIDE | Oxyfresh Worldwide Inc | 0ae98f28-7e78-4379-93b0-4f2657415c4d | 2023-10-25 | Warnings | M021 |
| Tanners Tasty Vanilla Bling | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 521fe01e-7f2e-4d79-9126-e4880cdf4e71 | 2023-10-24 | Warnings | M021 |
| Tanners Tasty Ooh La La Orange | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 6027b961-314e-4f71-8b2f-646ce80214d8 | 2023-10-24 | Warnings | M021 |
| Tanners Tasty Cha Cha Chocolate | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 8609dbf3-7620-4a13-b40b-6bd705a78fb0 | 2023-10-24 | Warnings | M021 |
| Glister Multi-Action | SODIUM FLUORIDE | Access Business Group LLC | e3f2c049-a0f5-4649-a4aa-11bdb252f951 | 2023-10-23 | Warnings | M021 |
| UNITED Asutra TC Kit Colgate | SODIUM MONOFLUOROPHOSPHATE | MING FAI ENTERPRISE (CAMBODIA) CO., LTD | 082a581a-c7e5-e614-e063-6394a90a87da | 2023-10-20 | Warnings | M021 |
| Plak Smacker Anti Cavity Fluoride | SODIUM FLUORIDE | YOUNG PS ACQUISITION, LLC | c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe | 2023-10-16 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 152d84ee-d981-4032-bfb1-a559afe71d40 | 2023-10-11 | Warnings | M021 |
| Sodium Fluoride | SODIUM FLUORIDE | Safco Dental Supply LLC | 788080b3-fff8-4049-af98-f571824994c2 | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 5c312b36-07f4-406e-b3d3-c6d1e964635d | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 042636cf-8b61-4022-b0a1-af09c06b145b | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | f4c3569b-7b6a-4566-9e87-492f291c5165 | 2023-10-11 | Warnings | M021 |
| UNITED Asutra TC Kit Colgate | SODIUM MONOFLUOROPHOSPHATE | Procurall Solutions | 042817f9-675f-056a-e063-6394a90a2d97 | 2023-08-30 | Warnings | M021 |
| Colgate Max Fresh Cool Mint | SODIUM FLUORIDE | Mission Hills S.A de C.V | d142e43f-415a-41c5-a7db-8b18a039a323 | 2019-04-09 | Warnings | M021 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54473-337-04 | 54473033704 | 93.5 g in 1 TUBE (54473-337-04) | 93.5 g | 2022-01-08 | 0000-00-00 | No | No | Current |