FDA.reportPublic FDA data

Colgate

Manufacturer
Colgate-Palmolive Company
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:31

Label at a glance#

ProductColgate Total Enamel Strength
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

aids in the prevention of cavities helps prevent gingivitis helps interfere with harmful effects of plaque associated with gingivitis builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Dosage and administration

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. do not swallow. children under 12 years of age: consult a dentist.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, Antigingivitis, Antisensitivity

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with harmful effects of plaque associated with gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

OTC - STOP USE SECTION

Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.

Other information

SPL UNCLASSIFIED SECTION

  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Colgate product is specially formulated to help prevent staining.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Hydrated Silica, Glycerin, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Cellulose Gum, Potassium Nitrate, Sodium Saccharin, Xanthan Gum, Cocamidopropyl Betaine, Titanium Dioxide.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

Total
ACTIVE PREVENTION

NET WT 3.0 OZ (85 g)

WHITENING
PASTE

CLINICALLY
PROVEN

ANTIBACTERIAL
24
HOUR1

✓ Gingivitis ✓ Plaque ✓ Tartar ✓ Sensitivity
✓ Weak Enamel ✓ Stains ✓ Bad Breath ✓ Cavities

Enamel
Strength

Reduces Sensitivity
and Remineralizes
to Strengthen
Weak Enamel

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY1

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-28435000-284-63

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
POTASSIUM NITRATERU45X2JN0ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
ndc (package): 35000-284-63
ndc (product): 35000-284
ndc11 (package): 35000028463
spl id: a40dd736-4209-4c86-897b-8c7b8781b8a9
spl set id: 1f29c893-e7c5-4a0e-941b-c2634d821147

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.