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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDELidl US, LLCc47475aa-3125-410f-aa31-0add6e4ce1252026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf4c02924-95ee-09d2-e053-2995a90a81212026-02-03Exact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5d97011-7be3-3b1c-e053-2a95a90ade862026-02-03Exact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc.c28c3475-efbb-4099-83ab-ab91bac9dfc32026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEDemoulas Super Markets, Inc65abfb4d-3a1e-42df-b343-f270ce60a3bf2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company102e4d9c-0fae-d48a-e063-6294a90aac942026-02-03WarningsExact identifier
application number: M021
Crest Plus Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08767b0f-ed6e-8d32-e063-6294a90a10cd2026-02-03WarningsExact identifier
application number: M021
Crest Braces Care Anticavity Fluoride RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd8398cfd-9af6-690d-e053-2995a90a9b7c2026-02-03WarningsExact identifier
application number: M021
AutoBrush bubblegumSODIUM FLUORIDELander Enterprises, LLC2e85d6f7-2df8-4eb9-bc97-d7b7af7fb4602026-02-03WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLCd859d02d-a036-4d90-bed4-9a5c31e9e1ef2026-02-03WarningsExact identifier
application number: M021
Glowing WhiteSODIUM FLUORIDEDemoulas Super Markets, Inc32faf47d-b64f-4454-9f14-51503504c6b52026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Sodium fluorideSODIUM FLUORIDEDemoulas Super Markets, Inc2f5d3c75-1a11-47e1-b297-e2302177efe72026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc096e6a1d-316b-432a-bf27-70e8a13337cc2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d1932f-a85c-7b8f-e063-6394a90a6aca2026-02-02WarningsExact identifier
application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d4f96f-e61f-e6e6-e063-6294a90ab0a02026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Toy Story Wild West WatermelonSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d69901-0b07-b07d-e063-6394a90a3c342026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Frozen Blizzard BerrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6c1c9-cd21-cac6-e063-6294a90a81d62026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Princesses Grand GrapeSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6f926-da4e-26df-e063-6294a90a1c0c2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker PunchSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d70b88-d57c-37cd-e063-6294a90a4a592026-02-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERite Aid Corporation54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe2026-02-02Warnings, Adverse reactionsExact 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