FDA.reportPublic FDA data

Crest Pro-Health Whitening Gel

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:00

Label at a glance#

ProductCrest Pro Health Whitening Gel
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 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, 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

WARNINGS SECTION

Warnings

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

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, glycine, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 167 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

69423-78669423-786Crest

PRO-HEALTH

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

CAVITIES GUM ENAMEL SENSITIVITY PLAQUE TARTAR WHITENS FRESHENS BREATH

NET WT 5.9 OZ (167 g)

FORMULATED WITH AMINO ACID GLYCINE

WHITENING

PROTECTS 100%

OF THE WHOLE MOUTH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN7
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD7
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90276690Crest Pro Health Whitening Gel.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
69423-786-03CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-03CrestPro Health Whitening Gel85 g in 1 TUBEPASTE, DENTIFRICE857
69423-786-21CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-21CrestPro Health Whitening Gel59 g in 1 TUBEPASTE, DENTIFRICE597
69423-786-43CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-43CrestPro Health Whitening Gel121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-786-44CrestPro Health Whitening Gel121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-786-44CrestPro Health Whitening Gel2 in 1 CARTONPASTE, DENTIFRICE27
69423-786-45CrestPro Health Whitening Gel3 in 1 CARTONPASTE, DENTIFRICE37
69423-786-45CrestPro Health Whitening Gel121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-786-46CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-46CrestPro Health Whitening Gel130 g in 1 TUBEPASTE, DENTIFRICE1307
69423-786-59CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-59CrestPro Health Whitening Gel167 g in 1 TUBEPASTE, DENTIFRICE1677

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
69423-78669423-786-43, 69423-786-44, 69423-786-45, 69423-786-59, 69423-786-03, 69423-786-46, 69423-786-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
STANNOUS CHLORIDE1BQV3749L5IACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL506T60A25RIACT
GLYCINETE7660XO1CIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM GLUCONATER6Q3791S76IACT
STANNOUS FLUORIDE3FTR44B32QACTIM
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
ZINC CITRATEK72I3DEX9BIACT
MICAV8A1AW0880IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-09-16full-release2026-06-01 01:13:57

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 Whitening GelSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb5b1e94-bed6-8486-e053-6294a90a3a842026-01-08WarningsExact identifier
ndc (package): 69423-786-43
ndc (package): 69423-786-03
ndc (package): 69423-786-44
ndc (package): 69423-786-59
ndc (package): 69423-786-46
ndc (package): 69423-786-45
ndc (package): 69423-786-21
ndc (product): 69423-786
ndc11 (package): 69423078645
ndc11 (package): 69423078643
ndc11 (package): 69423078646
ndc11 (package): 69423078603
ndc11 (package): 69423078621
ndc11 (package): 69423078644
ndc11 (package): 69423078659
spl id: 47e3b087-097d-33a9-e063-6394a90a0c62
spl set id: fb5b1e94-bed6-8486-e053-6294a90a3a84

Reported adverse events (FAERS/openFDA)#

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