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
8
Source
monthly-update
Hydrated at
2026-06-03 17:52:21

Label at a glance#

ProductCrest Pro-Health Gum Detoxify Ultra
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 12 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 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 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

Warning

WARNINGS SECTION

Keep out of reach of children under 12 yrs. of age. 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 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 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, carrageenan, sodium gluconate, flavor, xanthan gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 147 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest®

PRO-HEALTH™

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

GUM DETOXIFY™

ULTRA

Neutralizes plaque bacteria, even around the gum line

DEEP CLEAN

GENTLE WHITENING

EXTRA FRESH

ACTIVATED FOAM

NET WT 5.2 OZ (147 g)

6942395269423952

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN8
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD8
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY8
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY8
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY8

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
69423-952-04Crest Pro-HealthGum Detoxify Ultra133 g in 1 TUBEPASTE, DENTIFRICE1338
69423-952-04Crest Pro-HealthGum Detoxify Ultra4 in 1 CARTONPASTE, DENTIFRICE48
69423-952-47Crest Pro-HealthGum Detoxify Ultra1 in 1 CARTONPASTE, DENTIFRICE18
69423-952-47Crest Pro-HealthGum Detoxify Ultra133 g in 1 TUBEPASTE, DENTIFRICE1338
69423-952-52Crest Pro-HealthGum Detoxify Ultra1 in 1 CARTONPASTE, DENTIFRICE18
69423-952-52Crest Pro-HealthGum Detoxify Ultra147 g in 1 TUBEPASTE, DENTIFRICE1478

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-95269423-952-52, 69423-952-47, 69423-952-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
TITANIUM DIOXIDE15FIX9V2JPIACT
SUCRALOSE96K6UQ3ZD4IACT
STANNOUS CHLORIDE1BQV3749L5IACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC CITRATEK72I3DEX9BIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-08-14full-release2026-06-01 01:10:44

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 Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
ndc (package): 69423-952-04
ndc (package): 69423-952-52
ndc (package): 69423-952-47
ndc (product): 69423-952
ndc11 (package): 69423095247
ndc11 (package): 69423095252
ndc11 (package): 69423095204
spl id: 47e4cda7-53e6-6dcf-e063-6394a90ae844
spl set id: c73ed36a-0e2f-a137-e053-2a95a90a43e0

Reported adverse events (FAERS/openFDA)#

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