FDA.reportPublic FDA data

Colgate Total SF Advanced Whitening

Product NDC
35000-178
11-digit product format
350000178
Labeler code
35000
Product ID
35000-178_54eebf5f-0d5a-40d0-9b4f-fface020bc3d
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
2019-05-14
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 SF Advanced Whitening

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
35000-178-14Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-14Colgate Total SF Advanced Whitening39.6 g in 1 TUBEPASTE, DENTIFRICE39.614
35000-178-18Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-18Colgate Total SF Advanced Whitening5 in 1 CELLO PACKPASTE, DENTIFRICE514
35000-178-25Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-25Colgate Total SF Advanced Whitening24.9 g in 1 TUBEPASTE, DENTIFRICE24.914
35000-178-47Colgate Total SF Advanced Whitening144 g in 1 TUBEPASTE, DENTIFRICE14414
35000-178-47Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-64Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-64Colgate Total SF Advanced Whitening181 g in 1 TUBEPASTE, DENTIFRICE18114
35000-178-65Colgate Total SF Advanced Whitening144 g in 1 TUBEPASTE, DENTIFRICE14414
35000-178-65Colgate Total SF Advanced Whitening2 in 1 CARTONPASTE, DENTIFRICE214
35000-178-93Colgate Total SF Advanced Whitening96 g in 1 TUBEPASTE, DENTIFRICE9614
35000-178-93Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-178COLGATE TOTAL SF ADVANCED WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]14Current NDC, Legacy NDC, 14 package rows20240929_f8aeac8e-6a3e-4ada-bb13-db337b934ba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf8aeac8e-6a3e-4ada-bb13-db337b934ba314
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf8aeac8e-6a3e-4ada-bb13-db337b934ba314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-178-14350000178141 TUBE in 1 CARTON (35000-178-14) > 39.6 g in 1 TUBE1 tube2019-05-142023-03-31NoNoCurrent
35000-178-18350000178185 CARTON in 1 CELLO PACK (35000-178-18) / 1 TUBE in 1 CARTON / 181 g in 1 TUBE5 carton2023-03-202026-12-31NoNoHistorical
35000-178-25350000178251 TUBE in 1 CARTON (35000-178-25) > 24.9 g in 1 TUBE1 tube2019-05-142022-12-31NoNoCurrent
35000-178-47350000178471 TUBE in 1 CARTON (35000-178-47) > 144 g in 1 TUBE1 tube2019-05-140000-00-00NoNoCurrent
35000-178-64350000178641 TUBE in 1 CARTON (35000-178-64) / 181 g in 1 TUBE1 tube2019-05-142026-12-31NoNoCurrent
35000-178-65350000178652 TUBE in 1 CARTON (35000-178-65) > 144 g in 1 TUBE2 tube2019-05-142023-01-31NoNoCurrent
35000-178-93350000178931 TUBE in 1 CARTON (35000-178-93) > 96 g in 1 TUBE1 tube2019-05-140000-00-00NoNoCurrent