FDA.reportPublic FDA data

TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT

Product NDC
51009-921
11-digit product format
510090921
Labeler code
51009
Product ID
51009-921_e01ecaef-cd8c-4bb4-83f5-f8e7eb55469c
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
2025-01-01
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 WHITEN PLUS DEEP CLEAN SPEARMINT
Listing expiration
2027-12-31

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
1fe50b49-bc62-4137-866c-e87bb878a96dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-921-40Toms of Maine Deep Clean Spearmint1 in 1 CARTONPASTE, DENTIFRICE11
51009-921-40Toms of Maine Deep Clean Spearmint113 g in 1 TUBEPASTE, DENTIFRICE1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-921TOMS OF MAINE DEEP CLEAN SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE]1Current NDC, 2 package rows20250101_1fe50b49-bc62-4137-866c-e87bb878a96d.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 17 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company126c6f39-0ef7-40ee-b3ba-e56a76739c572026-02-12WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.b2f7490c-e2af-49df-b054-70fb4815f7292026-02-11Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INC287887df-64de-4b5d-80e2-146c77c0fa8b2026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES White Care AO ProSODIUM FLUORIDEPERIOSCIENCES LLC092bdfa3-6267-439e-9320-e51b4805d1a12026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES HYDRATING AO ProSODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLC5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d32026-02-09WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERetail Business Services, LLC77c066cf-f064-45d3-9732-4433165ba9ef2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDERetail Business Services, LLCd1c878a9-2151-4986-be09-cbab658cdd312026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDERetail Business Services, LLC542e067a-c134-44c9-b962-f2a2b667b76f2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERetail Business Services, LLC3954edfd-f7f1-4218-9ee2-23f5b3661b4e2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Kids Anticavity Oral Rinse BubblegumANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.2770424d-7416-66d4-e063-6394a90ad4b12026-02-06WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity Whitening Plus ScopeSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company463b7820-a5ce-f8b5-e063-6394a90aa0182026-02-05WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.14494238-872b-49e2-8bf7-df3844a0a6c82026-02-05Warnings, Adverse reactionsExact identifier
application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150SODIUM MONOFLUOROPHOSPHATELAMOIYAN CORPORATION14c14694-6149-40a8-aff2-660d39f7e0c12026-02-05WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEHARRIS TEETERf759e9e4-6de2-4b80-903b-e67c06e362952026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEHARRIS TEETER571f7628-fd59-462f-96dd-67aeaa98cff12026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN1fe50b49-bc62-4137-866c-e87bb878a96d1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1fe50b49-bc62-4137-866c-e87bb878a96d1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1fe50b49-bc62-4137-866c-e87bb878a96d1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1fe50b49-bc62-4137-866c-e87bb878a96d1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1fe50b49-bc62-4137-866c-e87bb878a96d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51009-921-40510090921401 TUBE in 1 CARTON (51009-921-40) / 113 g in 1 TUBE1 tube2025-01-01NoNoCurrent