Is Tom's of Maine, Inc. FDA approved?

Tom's of Maine, Inc. 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 Tom's of Maine, Inc.'s drugs manufactured?

The FDA register lists Sanford, ME. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Tom's of Maine, Inc. make?

24 products are listed under Tom's of Maine, Inc. in the openFDA NDC Directory, most often as paste, dentifrice; rinse; stick. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Tom's of Maine, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 22
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Tom's of Maine, Inc.	27 Community Drive, Sanford, Maine (ME) 04073, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1218077829517189

Catalogue

Drug listings by form and route

22 active NDC listings: 22 human otc drug. By marketing category: OTC MONOGRAPH DRUG 22.

Dosage form	NDCs
paste, dentifrice	19
rinse	2
stick	1

Route	NDCs
dental	21
topical	1

Labeller name on the listing	NDCs
tom's of maine, inc.	19
tom's of maine	3

Catalogue

Marketed products

Showing 22 of 24.

Brand	Generic name	Form / route	NDC
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	Sodium fluoride	paste, dentifrice, dental	51009-238OTC MONOGRAPH DRUG
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT	Sodium Fluoride	paste, dentifrice, dental	51009-900OTC MONOGRAPH DRUG
TOMS OF MAINE ANTICAVITY FRESHMINT	Sodium Fluoride	paste, dentifrice, dental	51009-862OTC MONOGRAPH DRUG
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO	SODIUM MONOFLUOROPHOSPHATE	paste, dentifrice, dental	51009-911OTC MONOGRAPH DRUG
TOMS OF MAINE KIDS SILLY STRAWBERRY	SODIUM MONOFLUOROPHOSPHATE	paste, dentifrice, dental	51009-910OTC MONOGRAPH DRUG
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT	Sodium Fluoride	paste, dentifrice, dental	51009-921OTC MONOGRAPH DRUG
TOMS OF MAINE WHOLE CARE SPEARMINT	Sodium monofluorophosphate	paste, dentifrice, dental	51009-857OTC MONOGRAPH DRUG
TOMS OF MAINE WHOLE CARE SPEARMINT	Sodium monofluorophosphate	paste, dentifrice, dental	51009-858OTC MONOGRAPH DRUG
TOMS OF MAINE WHOLE CARE WINTERMINT	Sodium Monofluorophosphate	paste, dentifrice, dental	51009-902OTC MONOGRAPH DRUG
TOMS OF MAINE WICKED COOL MILD MINT	SODIUM MONOFLUOROPHOSPHATE	paste, dentifrice, dental	51009-912OTC MONOGRAPH DRUG
TOMS OF MAINE WICKED FRESH COOL PEPPERMINT	Sodium monofluorophosphate	paste, dentifrice, dental	51009-859OTC MONOGRAPH DRUG
TOMS OF MAINE WICKED FRESH SPEARMINT ICE	Sodium monofluorophosphate	paste, dentifrice, dental	51009-860OTC MONOGRAPH DRUG
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	Sodium monofluorophosphate	paste, dentifrice, dental	51009-202OTC MONOGRAPH DRUG
Toms Childrens Anticavity Mouthwash Silly Strawberry	sodium fluoride	rinse, dental	51009-840OTC MONOGRAPH DRUG
Toms Kids Watermelon Wiggle	Sodium Monofluorophosphate	paste, dentifrice, dental	51009-854OTC MONOGRAPH DRUG
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	Sodium Monofluorophosphate	paste, dentifrice, dental	51009-219OTC MONOGRAPH DRUG
Toms Whole Care Mouthwash Fresh Mint	Sodium Fluoride	rinse, dental	51009-837OTC MONOGRAPH DRUG
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	Sodium monofluorophosphate	paste, dentifrice, dental	51009-203OTC MONOGRAPH DRUG
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	Sodium Monofluorophosphate	paste, dentifrice, dental	51009-205OTC MONOGRAPH DRUG
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	Sodium Monofluorophosphate	paste, dentifrice, dental	51009-206OTC MONOGRAPH DRUG
Toms of Maine Tropical Island	Aluminum chlorohydrate	stick, topical	51009-861OTC MONOGRAPH DRUG
Toms of Maine Whiten Plus Deep Clean Peppermint	Sodium Fluoride	paste, dentifrice, dental	51009-920OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Tom's of Maine, Inc. FDA approved?: Tom's of Maine, Inc. 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 Tom's of Maine, Inc.'s drugs manufactured?: The FDA register lists Sanford, ME. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Tom's of Maine, Inc. make?: 24 products are listed under Tom's of Maine, Inc. in the openFDA NDC Directory, most often as paste, dentifrice; rinse; stick. 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.