Labeler · US market

Elevate Oral Care

Elevate Oral Care is a US drug labeler with US FDA registrations covering 6 drug concepts (6 currently active) across 13 packages. It is currently the only active US supplier of 6 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes57511

Active drugs6

Registrations10 active / 10

Packages13

Sole supplier of6 drugs

Portfolio6 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
1.1% Sodium Fluoride Toothpaste gel, dentifrice	rx	3	3	SUPPLYING
1.1% Sodium Fluoride Toothpaste paste, dentifrice	rx	2	3	SUPPLYING
0.63% Stannous Fluoride Concentrate Rinse rinse	otc	2	2	SUPPLYING
Povidone-Iodine 10% Topical liquid	otc	1	2	SUPPLYING
1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste paste, dentifrice	rx	1	2	SUPPLYING
1.1% Sodium Fluoride Toothpaste paste, dentifrice	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes57511
Filing names1
Drugs (active)6
Drugs (all time)6
US registrations10
Packages13

Recent events

Shortages, recalls, and registration changes across all filing names.

Jun 4, 2026
RECALLRecall (Class II): Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Be…
Aug 20, 2024
RECALLRecall (Class III): Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral …

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.