Colgate Total Enamel Strength

Product NDC
35000-284
11-digit product format
350000284
Labeler code
35000
Product ID
35000-284_a40dd736-4209-4c86-897b-8c7b8781b8a9
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
2026-04-03
Substance
STANNOUS 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
Colgate Total Enamel Strength
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui416784

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-284-63Colgate Total Enamel Strength85 g in 1 TUBEPASTE, DENTIFRICE851
35000-284-63Colgate Total Enamel Strength1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY1f29c893-e7c5-4a0e-941b-c2634d8211471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-284-63350000284631 TUBE in 1 CARTON (35000-284-63) / 85 g in 1 TUBE1 tube2026-04-03NoNoHistorical