FDA.reportPublic FDA data

Colgate Total Whitening Charcoal

Product NDC
35000-571
11-digit product format
350000571
Labeler code
35000
Product ID
35000-571_a95051eb-ef65-4886-b899-5fae8e271aaf
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-10
Marketing end
2026-12-31
Substance
STANNOUS FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Total Whitening Charcoal

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui416784

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-571-32Colgate Total Whitening Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
35000-571-32Colgate Total Whitening Charcoal93 g in 1 TUBEPASTE, DENTIFRICE9310
35000-571-48Colgate Total Whitening Charcoal136 g in 1 TUBEPASTE, DENTIFRICE13610
35000-571-48Colgate Total Whitening Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
35000-571-65Colgate Total Whitening Charcoal144 g in 1 TUBEPASTE, DENTIFRICE14410
35000-571-65Colgate Total Whitening Charcoal2 in 1 CARTONPASTE, DENTIFRICE210
35000-571-66Colgate Total Whitening Charcoal144 g in 1 TUBEPASTE, DENTIFRICE14410
35000-571-66Colgate Total Whitening Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
35000-571-96Colgate Total Whitening Charcoal136 g in 1 TUBEPASTE, DENTIFRICE13610
35000-571-96Colgate Total Whitening Charcoal2 in 1 CARTONPASTE, DENTIFRICE210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-571COLGATE TOTAL WHITENING CHARCOAL (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]10Current NDC, Legacy NDC, 10 package rows20241003_56434e3d-ba0a-8b42-6c97-0d0055606793.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY56434e3d-ba0a-8b42-6c97-0d005560679310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-571-32350000571321 TUBE in 1 CARTON (35000-571-32) / 93 g in 1 TUBE1 tube2021-01-202026-12-31NoNoCurrent
35000-571-48350000571481 TUBE in 1 CARTON (35000-571-48) > 136 g in 1 TUBE1 tube2020-12-100000-00-00NoNoCurrent
35000-571-65350000571652 TUBE in 1 CARTON (35000-571-65) / 144 g in 1 TUBE2 tube2021-12-082026-12-31NoNoCurrent
35000-571-66350000571661 TUBE in 1 CARTON (35000-571-66) / 144 g in 1 TUBE1 tube2021-12-272026-12-31NoNoCurrent
35000-571-96350000571962 TUBE in 1 CARTON (35000-571-96) > 136 g in 1 TUBE2 tube2020-12-110000-00-00NoNoCurrent