FDA.reportPublic FDA data

Crest Pro-Health Advanced Bacteria Protection

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:23

Label at a glance#

ProductCrest Pro-Health Advanced Bacteria Protection
Active ingredientSTANNOUS FLUORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

adults and children 12 yrs. of age & 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%

(0.14% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, antigingivitis, antisensitivity toothpaste

Uses

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS 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. of age & 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

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, flavor, carrageenan, sodium
citrate, xanthan gum, zinc citrate, sodium saccharin, 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 - 144 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest®

PRO HEALTH™

NET WT
5.1 OZ (144 g)

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

CAVITIES
GINGIVITIS
ENAMEL
SENSITIVITY
PLAQUE
TARTAR
WHITENING
FRESHENS
BREATH

DENTIST DESIGNED

CLINICALLY PROVEN

ADVANCED

BACTERIA PROTECTION

PROTECTS AGAINST THE SPREAD OF BACTERIA -
THE ROOT CAUSE OF ISSUES IN THE MOUTH**

LABELLABEL

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codescan.pg.com/01/00030772234525Screenshot 2026-04-10 102619.pdf.jpg
Data codeData Matrix21354354Screenshot 2026-04-10 102619.pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-638-05Crest Pro-HealthAdvanced Bacteria Protection2 in 1 CARTONPASTE, DENTIFRICE21
84126-638-05Crest Pro-HealthAdvanced Bacteria Protection144 g in 1 TUBEPASTE, DENTIFRICE1441
84126-638-51Crest Pro-HealthAdvanced Bacteria Protection1 in 1 CARTONPASTE, DENTIFRICE11
84126-638-51Crest Pro-HealthAdvanced Bacteria Protection144 g in 1 TUBEPASTE, DENTIFRICE1441

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-63884126-638-51, 84126-638-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
STANNOUS CHLORIDE1BQV3749L5IACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC CITRATEK72I3DEX9BIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM CITRATE1Q73Q2JULRIACT
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 Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsExact identifier
ndc (package): 84126-638-05
ndc (package): 84126-638-51
ndc (product): 84126-638
ndc11 (package): 84126063851
ndc11 (package): 84126063805
spl id: 4f1d0452-e040-cda6-e063-6394a90a2aef
spl set id: 4f1ce508-fe6e-4045-e063-6294a90ab3e2

Reported adverse events (FAERS/openFDA)#

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