Register entry

Den-Mat Holdings, LLC

Data as of · How to read this entry

Registered sites
1
Active NDC listings
10
Labeller names
4
Live patents
0
Countries
1
Base
United States
Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
Den-Mat Holdings, LLC dba Clinician's ChoiceRegistrant: Den-Mat Holdings, LLC1017 West Central Ave, Lompoc, California (CA) 93436, United States (USA)Labelling, Finished drug manufacture, Packaging2018957809857704
Catalogue

Drug listings by form and route

10

10 active NDC listings: 5 human otc drug, 5 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 5, UNAPPROVED DRUG OTHER 4, ANDA 1.

Dosage formNDCs
rinse4
paste, dentifrice3
gel2
liquid1
RouteNDCs
oral7
dental5
Labeller name on the listingNDCs
den-mat holdings, llc.5
den-mat holdings, llc3
den-mat holdings, llc1
den-mat holdings, llc1
Catalogue

Marketed products

10
BrandGeneric nameForm / routeNDC
Chlorhexidine GluconateChlorhexidine Gluconaterinse, oral59883-175ANDA
FLUORIDEXSodium Fluoridepaste, dentifrice, dental59883-016UNAPPROVED DRUG OTHER
FLUORIDEXSodium Fluoridepaste, dentifrice, dental59883-020UNAPPROVED DRUG OTHER
FluoridexStannous Fluoride Rinseliquid, oral59883-004OTC MONOGRAPH DRUG
Kids KareSodium Fluoridepaste, dentifrice, dental, oral59883-718OTC MONOGRAPH DRUG
PerioRestoreHydrogen Peroxidegel, dental59883-018OTC MONOGRAPH DRUG
Pro-Den RxStannous Fluoriderinse, oral59883-720OTC MONOGRAPH DRUG
Pro-Den RxSodium Fluoriderinse, oral59883-911UNAPPROVED DRUG OTHER
Pro-Den RxSodium Fluoriderinse, oral59883-920UNAPPROVED DRUG OTHER
kids kareStannous Fluoridegel, dental, oral59883-404OTC MONOGRAPH DRUG
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Enquiry

Common questions

Is Den-Mat Holdings, LLC FDA approved?
Den-Mat Holdings, LLC 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 Den-Mat Holdings, LLC's drugs manufactured?
The FDA register lists Lompoc, CA. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Den-Mat Holdings, LLC make?
10 products are listed under Den-Mat Holdings, LLC in the openFDA NDC Directory, most often as rinse; paste, dentifrice; gel. 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.