FDA.reportPublic FDA data

Toms of Maine Whiten Plus Deep Clean Peppermint

Product NDC
51009-920
11-digit product format
510090920
Labeler code
51009
Product ID
51009-920_ecb6dca1-5bf7-4097-b825-e63cbc7d88fd
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine
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

Additional Listing Data#

Finished product
Yes
Brand name base
Toms of Maine Whiten Plus Deep Clean Peppermint
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-920-40Toms of Maine Whiten Plus Deep Clean Peppermint1 in 1 CARTONPASTE, DENTIFRICE14
51009-920-40Toms of Maine Whiten Plus Deep Clean Peppermint113 g in 1 TUBEPASTE, DENTIFRICE1134
51009-920-63Toms of Maine Whiten Plus Deep Clean Peppermint85 g in 1 TUBEPASTE, DENTIFRICE854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-920TOMS OF MAINE WHITEN PLUS DEEP CLEAN PEPPERMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE]1Current NDC, 3 package rows20250101_4c535776-3f80-4eeb-bb63-2d734c3c3a6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN4c535776-3f80-4eeb-bb63-2d734c3c3a6b4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD4c535776-3f80-4eeb-bb63-2d734c3c3a6b4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY4c535776-3f80-4eeb-bb63-2d734c3c3a6b4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4c535776-3f80-4eeb-bb63-2d734c3c3a6b4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4c535776-3f80-4eeb-bb63-2d734c3c3a6b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51009-920-40510090920401 TUBE in 1 CARTON (51009-920-40) / 113 g in 1 TUBE1 tube2025-01-01NoNoHistorical
51009-920-635100909206385 g in 1 TUBE (51009-920-63) 85 g2026-02-01NoNoHistorical