Register entry
- Registered sites
- 1
- Active NDC listings
- 10
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Finished drug manufacture1Relabelling1Repackaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Elevate Oral Care | 346 Pike Rd Suite 1, 5, 13, & 23, West Palm Beach, Florida (FL) 33411, United States (USA) | Finished drug manufacture, Relabelling, Repackaging | 3009603151002863526 |
Catalogue
Drug listings by form and route
1010 active NDC listings: 7 human prescription drug, 3 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 7, OTC MONOGRAPH DRUG 3.
| Dosage form | NDCs |
|---|---|
| paste, dentifrice | 4 |
| gel, dentifrice | 3 |
| rinse | 2 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| topical | 9 |
| dental | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| elevate oral care | 10 |
Catalogue
Marketed products
10| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Allday 5000 | 1.1% Sodium Fluoride Toothpaste | paste, dentifrice, topical | 57511-0005UNAPPROVED DRUG OTHER |
| Allday 5000 Sensitive | 1.1% Sodium Fluoride Toothpaste | paste, dentifrice, dental | 57511-0006UNAPPROVED DRUG OTHER |
| FluoriMax 5000 | 1.1% Sodium Fluoride Toothpaste | paste, dentifrice, topical | 57511-0504UNAPPROVED DRUG OTHER |
| FluoriMax 5000 Sensitive | 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste | paste, dentifrice, topical | 57511-0503UNAPPROVED DRUG OTHER |
| Just Right 5000 | 1.1% Sodium Fluoride Toothpaste | gel, dentifrice, topical | 57511-0001UNAPPROVED DRUG OTHER |
| Just Right 5000 | 1.1% Sodium Fluoride Toothpaste | gel, dentifrice, topical | 57511-0002UNAPPROVED DRUG OTHER |
| Just Right 5000 | 1.1% Sodium Fluoride Toothpaste | gel, dentifrice, topical | 57511-0003UNAPPROVED DRUG OTHER |
| Povi-One | Povidone-Iodine 10% topical | liquid, topical | 57511-0611OTC MONOGRAPH DRUG |
| Stance | 0.63% Stannous Fluoride Concentrate Rinse | rinse, topical | 57511-0201OTC MONOGRAPH DRUG |
| Stance | 0.63% Stannous Fluoride Concentrate Rinse | rinse, topical | 57511-0202OTC MONOGRAPH DRUG |
Neighbours
Registered in the same town
1- TransOx, Inc.West Palm Beach, FL
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Enquiry
Common questions
- Is Elevate Oral Care FDA approved?
- Elevate Oral Care holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Elevate Oral Care's drugs manufactured?
- The FDA register lists West Palm Beach, FL. Registered operations: finished drug manufacture, relabelling, repackaging.
- What drugs does Elevate Oral Care make?
- 10 products are listed under Elevate Oral Care in the openFDA NDC Directory, most often as paste, dentifrice; gel, dentifrice; rinse. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.