FDA.reportPublic FDA data

Crest Pro-Health

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:32:13

Label at a glance#

ProductCrest Pro-Health Densify Active Repair
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

aids in the prevention of cavities builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Dosage and administration

adults and children 12 yrs. & 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. Make sure to brush all sensitive areas of the teeth do not swallow children under 12 yrs. of age: ask a dentist

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Stannous fluoride 0.454%

(0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, antisensitivity toothpaste

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product do not use for sensitivity longer than four 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.

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 yrs. & 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. Make sure to brush all sensitive areas of the teeth
  • do not swallow
  • children under 12 yrs. of age: ask a dentist

Other information

WARNINGS AND PRECAUTIONS 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 Crest is specially formulated to help prevent staining
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium citrate, flavor, sodium gluconate, carrageenan, xanthan gum, sodium saccharin, cocamidopropyl betaine, sodium hydroxide, stannous chloride, sucralose, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 99 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest

PRO HEALTH

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND SENSITIVE TEETH

DENSIFY

ACTIVE REPAIR

ACTIVELY REVERSES

EARLY DECAY

TO EXTEND THE LIFE OF TEETH*

ADVANCED WHITENING

3X DECAY

PRO

PREVENTION SYSTEM

NET WT 3.5 OZ (99g)

artwork Densify ARartwork Densify AR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN5
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD5
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130030772055489GTIN-13: 0030772055489
EAN-13: 0030772055489
GTIN-12: 030772055489
UPC-A: 030772055489
GTIN storage (14 digits): 00030772055489		POA-00381720.90281946.jpg
Data codeData Matrix90281946POA-00381720.90281946.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-754-35Crest Pro-HealthDensify Active Repair1 in 1 CARTONPASTE, DENTIFRICE15
69423-754-35Crest Pro-HealthDensify Active Repair99 g in 1 TUBEPASTE, DENTIFRICE995

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-75469423-754-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLOXAMER 407TUF2IVW3M2IACT
GLYCINETE7660XO1CIACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SUCRALOSE96K6UQ3ZD4IACT
STANNOUS CHLORIDE1BQV3749L5IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
Crest Pro-Health Densify Active RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4487d78-1da8-3f33-e053-2a95a90a6d922026-01-08WarningsExact identifier
ndc (package): 69423-754-35
ndc (product): 69423-754
ndc11 (package): 69423075435
spl id: 47e28597-136f-217d-e063-6294a90a2cec
spl set id: f4487d78-1da8-3f33-e053-2a95a90a6d92

Reported adverse events (FAERS/openFDA)#

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