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 firm2026-10-15

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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact 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