FDA.reportPublic FDA data

Colgate Sensitive Complete Protection

Manufacturer
Colgate-Palmolive Company
Effective date
2026-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:01

Label at a glance#

ProductColgate Sensitive Complete Protection
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact helps protect against cavities

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 bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years consult a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Potassium Nitrate 5%Antisensitivity
Sodium Fluoride 0.24% (0.14% w/v fluoride ion)Anticavity

Uses

INDICATIONS & USAGE SECTION

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

OTC - STOP USE SECTION

Stop use and ask a dentist if the 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and olderapply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 yearsconsult a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Hydrated Silica, Sorbitol, PEG-12, Tetrapotassium Pyrophosphate, PVM/MA Copolymer, Flavor, Sodium Lauryl Sulfate, Poloxamer 407, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, 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 - 170 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Toothpaste for Sensitive Teeth

2
VALUE
PACK

Soothing
Spearmint Flavor

SENSITIVE
Complete Protection

POTASSIUM NITRATE:
#1 Dentist1 Recommended
Active Ingredient For
Sensitivity Relief

PASTE

TWO 6.0 OZ (170 g) TUBES

TOTAL NET WT 12 OZ (340 g)

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN1
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD1
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-132-21Colgate Sensitive Complete Protection59 g in 1 TUBEPASTE, DENTIFRICE591
35000-132-21Colgate Sensitive Complete Protection1 in 1 CARTONPASTE, DENTIFRICE11
35000-132-34Colgate Sensitive Complete Protection170 g in 1 TUBEPASTE, DENTIFRICE1701
35000-132-34Colgate Sensitive Complete Protection2 in 1 CARTONPASTE, DENTIFRICE21
35000-132-60Colgate Sensitive Complete Protection1 in 1 CARTONPASTE, DENTIFRICE11
35000-132-60Colgate Sensitive Complete Protection170 g in 1 TUBEPASTE, DENTIFRICE1701
35000-132-78Colgate Sensitive Complete Protection1 in 1 CARTONPASTE, DENTIFRICE11
35000-132-78Colgate Sensitive Complete Protection22 g in 1 TUBEPASTE, DENTIFRICE221

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-13235000-132-60, 35000-132-34, 35000-132-21, 35000-132-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
METHYL VINYL ETHER AND MALEIC ACID COPOLYMER (1750000 WAMW)9F20VSM0VUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
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 Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company866067b9-3dce-492d-ae99-1b807ecd56ff2026-01-22WarningsExact identifier
ndc (package): 35000-132-21
ndc (package): 35000-132-34
ndc (package): 35000-132-78
ndc (package): 35000-132-60
ndc (product): 35000-132
ndc11 (package): 35000013234
ndc11 (package): 35000013260
ndc11 (package): 35000013221
ndc11 (package): 35000013278
spl id: 8554afd0-1aff-4b1f-8fc8-49b0b9aad95e
spl set id: 866067b9-3dce-492d-ae99-1b807ecd56ff

Reported adverse events (FAERS/openFDA)#

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