FDA.reportPublic FDA data

TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT

Product NDC
51009-900
11-digit product format
510090900
Labeler code
51009
Product ID
51009-900_a8944014-cc00-41f7-8ac9-ccae8024644e
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-18
Marketing end
2028-04-30
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51009-90051009-900-47DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51009-90051009-900-47DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9e6e455-8444-4805-89f1-ee9142f98e36Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-900-40Peppermint Charcoal Anticavity PCFT6gently whitens teeth / fights cavities / safe for enamel / safe for everyday use1 in 1 CARTONPASTE, DENTIFRICE19
51009-900-40Peppermint Charcoal Anticavity PCFT6gently whitens teeth / fights cavities / safe for enamel / safe for everyday use113 g in 1 TUBEPASTE, DENTIFRICE1139
51009-900-47Peppermint Charcoal Anticavity PCFT6gently whitens teeth / fights cavities / safe for enamel / safe for everyday use1 in 1 CARTONPASTE, DENTIFRICE19
51009-900-47Peppermint Charcoal Anticavity PCFT6gently whitens teeth / fights cavities / safe for enamel / safe for everyday use133 g in 1 TUBEPASTE, DENTIFRICE1339

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-900PEPPERMINT CHARCOAL ANTICAVITY PCFT6 GENTLY WHITENS TEETH / FIGHTS CAVITIES / SAFE FOR ENAMEL / SAFE FOR EVERYDAY USE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]8Current NDC, Legacy NDC, 4 package rows20241017_b9e6e455-8444-4805-89f1-ee9142f98e36.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company3bba340e-2a62-3b04-41b5-0ed9c13adb132026-04-22WarningsExact identifier
application number: M021
EverSmile SquirtSODIUM FLUORIDE 0.05%Everbrands, Inc.bc0ef174-2909-469a-b629-0eab4412bdfc2026-04-20WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmart41d6cc7a-0b87-e474-e063-6294a90ae9952026-04-20WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf2026-04-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEH E B8d40f693-083c-4eb6-9da1-42675d757e0e2026-04-16Warnings, Adverse reactionsExact identifier
application number: M021
Eversmile OrthoFoam Anticavity0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.9c12e792-94c8-4e29-9a54-e7e70aadade62026-04-16WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.6753b426-6d49-4438-a52f-c28e60a0e9d82026-04-16WarningsExact identifier
application number: M021
Osstem G Gum Health Care ToothSODIUM FLUORIDEOsstem Pharma Co., Ltd4f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Enamel StrengthSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4f6b8851-c778-8abd-e063-6294a90aef4f2026-04-14Exact identifier
application number: M021
Crest 3D White Stain Eraser Luxe MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6beb3b-2521-bfb7-e063-6394a90ad9ea2026-04-14Exact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d132026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6d11b2-5aa2-ab34-e063-6294a90ac0bc2026-04-14WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEPublix Super Markets, Inc.cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb2026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.f0e84078-499f-4a5a-bcd2-23f57805de862026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
Crest Pro-Health Advanced Multi-ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1cfc5b61-c8e5-943d-e063-6394a90a890b2026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Multi-Protection plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6f6299-f95f-2f0e-e063-6294a90a16412026-04-14WarningsExact identifier
application number: M021
Crest 3D White Strength Whitening Enamel ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f7125aa-3aa2-ca64-e063-6394a90a4cf32026-04-14WarningsExact identifier
application number: M021
Eversmile TheraFoam0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.57da2479-923a-45ec-8149-57b469b116372026-04-13WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company4f1d62ae-653e-3046-e063-6294a90abbf82026-04-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNb9e6e455-8444-4805-89f1-ee9142f98e369
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDb9e6e455-8444-4805-89f1-ee9142f98e369
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYb9e6e455-8444-4805-89f1-ee9142f98e369
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYb9e6e455-8444-4805-89f1-ee9142f98e369
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYb9e6e455-8444-4805-89f1-ee9142f98e369

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-900-01510090900011 TUBE in 1 CARTON (51009-900-01) > .75 g in 1 TUBE1 tube2019-11-150000-00-00NoNoCurrent
51009-900-1051009090010.75 g in 1 TUBE (51009-900-10) 2020-01-010000-00-00NoNoCurrent
51009-900-40510090900401 TUBE in 1 CARTON (51009-900-40) / 113 g in 1 TUBE1 tube2023-09-302028-04-30NoNoCurrent
51009-900-47510090900471 TUBE in 1 CARTON (51009-900-47) > 133 g in 1 TUBE1 tube2018-12-180000-00-00NoNoCurrent