Labeler · US market

Dental Alliance Holdings LLC

Dental Alliance Holdings LLC is a US drug labeler with US FDA registrations covering 2 drug concepts (2 currently active) across 12 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes61578

Active drugs2

Registrations10 active / 10

Packages12

Sole supplier of1 drugs

Portfolio2 drugs · US

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

Drug	Type	NDCs	Packages	Status
Sodium Fluoride gel, dentifrice	rx	5	6	SUPPLYING
Anticaries rinse	otc	5	6	SUPPLYING

Sole US supplier

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

Anticariesotc

At a glance

TypeLabeler
Labeler codes61578
Filing names1
Drugs (active)2
Drugs (all time)2
US registrations10
Packages12

Recent events

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

Dec 3, 2021
RECALLRecall (Class III): CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: …
Dec 3, 2021
RECALLRecall (Class III): CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral Bi…
Dec 3, 2021
RECALLRecall (Class III): CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC:…
Dec 3, 2021
RECALLRecall (Class III): CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: …
Dec 3, 2021
RECALLRecall (Class III): CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 …
Dec 3, 2021
RECALLRecall (Class III): CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-2…
Dec 3, 2021
RECALLRecall (Class III): CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx o…

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.