FDA.reportPublic FDA data

Crest Pro-Health Advanced

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:21

Label at a glance#

ProductCrest Pro-Health Advanced Extra Whitening
Active ingredientSTANNOUS FLUORIDE
Label structure11 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.: ask a dentist

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454%
(0.16% 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

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.: ask a dentist

Other information

STORAGE AND HANDLING 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, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, flavor, sodium lauryl sulfate, sodium gluconate, sodium saccharin, trisodium phosphate, carrageenan, xanthan gum, PVP, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 144 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROTECTS AGAINST AREAS DENTISTS CHECK MOST. Patented Stannous Fluoride Technology

Crest ® PRO-HEALTH™ ADVANCED

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

EXTRA WHITENING

Removes surface stains & protects against future stains.

CAVITIES GINGIVITIS ACID EROSION* SENSITIVITY PLAQUE TARTAR WHITENING FRESHENS BREATH

NET WT 5.1 OZ (144 g)

6942393869423938

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

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-938-35Crest Pro-Health AdvancedExtra Whitening1 in 1 CARTONGEL, DENTIFRICE15
69423-938-35Crest Pro-Health AdvancedExtra Whitening99 g in 1 TUBEGEL, DENTIFRICE995
69423-938-51Crest Pro-Health AdvancedExtra Whitening1 in 1 CARTONGEL, DENTIFRICE15
69423-938-51Crest Pro-Health AdvancedExtra Whitening144 g in 1 TUBEGEL, DENTIFRICE1445

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
69423-93869423-938-35, 69423-938-51

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 PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
WATER059QF0KO0RIACT
ZINC LACTATE2GXR25858YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-01-08full-release2026-06-01 00:51:35

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 Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
ndc (package): 69423-938-35
ndc (package): 69423-938-51
ndc (product): 69423-938
ndc11 (package): 69423093835
ndc11 (package): 69423093851
spl id: 47e4ce9f-8164-d4df-e063-6294a90a49e2
spl set id: c688d37e-9e80-4599-e053-2a95a90a1916

Reported adverse events (FAERS/openFDA)#

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