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
2
Source
monthly-update
Hydrated at
2026-06-03 17:52:30

Label at a glance#

ProductCrest Pro-Health Maximum Cavity Protection
Active ingredientSTANNOUS FLUORIDE
Label structure10 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

Dosage and administration

adults and children 6 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 6 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, antigingivitis 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

WARNINGS SECTION

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 6 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • do not swallow
  • children under 6 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 - 116 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest

Pro-Health

NET WT

4.3 OZ (121 g)

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

CAVITIES

GUM

ENAMEL

PLAQUE

WHITENS

FRESHENS

BREATH

MAXIMUM

CAVITY

PROTECTION

HELPS STOP CAVITIES

BEFORE THEY START

12h

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-608-03Crest Pro-HealthMaximum Cavity Protection121 g in 1 TUBEPASTE, DENTIFRICE1212
84126-608-03Crest Pro-HealthMaximum Cavity Protection3 in 1 CARTONPASTE, DENTIFRICE32
84126-608-04Crest Pro-HealthMaximum Cavity Protection121 g in 1 TUBEPASTE, DENTIFRICE1212
84126-608-04Crest Pro-HealthMaximum Cavity Protection2 in 1 CARTONPASTE, DENTIFRICE22
84126-608-26Crest Pro-HealthMaximum Cavity Protection73 g in 1 TUBEPASTE, DENTIFRICE732
84126-608-26Crest Pro-HealthMaximum Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE12
84126-608-43Crest Pro-HealthMaximum Cavity Protection121 g in 1 TUBEPASTE, DENTIFRICE1212
84126-608-43Crest Pro-HealthMaximum Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE12
84126-608-85Crest Pro-HealthMaximum Cavity Protection24 g in 1 TUBEPASTE, DENTIFRICE242

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-60884126-608-43, 84126-608-26, 84126-608-04, 84126-608-03, 84126-608-85

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
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SUCRALOSE96K6UQ3ZD4IACT
STANNOUS CHLORIDE1BQV3749L5IACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-02-21full-release2026-06-01 00:56:02

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 Maximum Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2eaeddc5-1559-9378-e063-6394a90a4ed72026-01-08WarningsExact identifier
ndc (package): 84126-608-04
ndc (package): 84126-608-43
ndc (package): 84126-608-03
ndc (package): 84126-608-26
ndc (package): 84126-608-85
ndc (product): 84126-608
ndc11 (package): 84126060804
ndc11 (package): 84126060885
ndc11 (package): 84126060803
ndc11 (package): 84126060843
ndc11 (package): 84126060826
spl id: 47e53855-2e47-b2a1-e063-6294a90a8be4
spl set id: 2eaeddc5-1559-9378-e063-6394a90a4ed7

Reported adverse events (FAERS/openFDA)#

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