FluoriMax 5000 Sensitive
- Product NDC
- 57511-0503
- 11-digit product format
- 575110503
- Labeler code
- 57511
- Product ID
- 57511-0503_3f2bd1e3-4ba2-1bdb-e063-6294a90af9b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste
- Dosage form
- PASTE, DENTIFRICE
- Route
- TOPICAL
- Labeler
- Elevate Oral Care
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2022-06-15
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 5; 1.1 g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FluoriMax 5000 Sensitive
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM NITRATE | 5 g/100g |
| SODIUM FLUORIDE | 1.1 g/100g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | RU45X2JN0Z, 8ZYQ1474W7 |
| Rxcui | 637365, 2603764 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57511-0503-1 | FluoriMax 5000 Sensitive | 96 g in 1 TUBE | PASTE, DENTIFRICE | 96 | 2 | |
| 57511-0503-2 | FluoriMax 5000 Sensitive | 2 in 1 BOX | PASTE, DENTIFRICE | 2 | 2 | |
| 57511-0503-1 | FluoriMax 5000 Sensitive | 96 g in 1 TUBE | PASTE, DENTIFRICE | 96 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57511-0503-1 | GM - Gram | 57511-0503 | f5abf26f-45fb-4a20-8633-bc3a44d34628 | 1 | 2023-08-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57511-0503 | FLUORIMAX 5000 SENSITIVE (1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE) PASTE, DENTIFRICE [ELEVATE ORAL CARE] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220615_d9f232c0-d154-536b-e053-2995a90af37d.zip |
| 57511-0503 | FLUORIMAX 5000 SENSITIVE (1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE) PASTE, DENTIFRICE [ELEVATE ORAL CARE] | 1 | Current NDC, Legacy NDC, 1 package rows | 20200902_ae32b0a2-e42f-6a56-e053-2a95a90a0b00.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2603764 | FluoriMax 5000 Sensitive 5 % / 1.1 % Toothpaste | PSN | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 637365 | potassium nitrate 5 % / sodium fluoride 1.1 % Toothpaste | PSN | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 2603764 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive] | SBD | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 637365 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste | SCD | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 2603764 | Fluorimax Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) Toothpaste | SY | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 637365 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste | SY | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 2603764 | K+ nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive] | SY | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 637365 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste | SY | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 2603764 | Pot nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive] | SY | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 637365 | potassium nitrate 5 % / sodium fluoride 1.1 % Gel Toothpaste | SY | d9f232c0-d154-536b-e053-2995a90af37d | 2 |
| 2603764 | FluoriMax 5000 Sensitive 5 % / 1.1 % Toothpaste | PSN | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 637365 | potassium nitrate 5 % / sodium fluoride 1.1 % Toothpaste | PSN | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 2603764 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive] | SBD | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 637365 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste | SCD | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 2603764 | Fluorimax Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) Toothpaste | SY | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 637365 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste | SY | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 2603764 | K+ nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive] | SY | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 637365 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste | SY | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 2603764 | Pot nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive] | SY | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
| 637365 | potassium nitrate 5 % / sodium fluoride 1.1 % Gel Toothpaste | SY | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57511-0503-1 | 57511050301 | 96 g in 1 TUBE (57511-0503-1) | 96 g | 2020-08-31 | 0000-00-00 | No | No | Current |
| 57511-0503-2 | 57511050302 | 2 TUBE in 1 BOX (57511-0503-2) / 96 g in 1 TUBE (57511-0503-1) | 2 tube | 2022-06-15 | 0000-00-00 | No | No | Current |