FDA.reportPublic FDA data

Crest Clean Breath Spearmint

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 01:53:24

Label at a glance#

ProductCrest Clean Breath Spearmint
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%

(0.15% 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

OTC - KEEP OUT OF REACH OF CHILDREN 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, sodium
gluconate, flavor, carrageenan, sodium citrate,
xanthan gum, zinc citrate, sodium hydroxide,
stannous chloride, sodium saccharin, sucralose,
mica, titanium dioxide, green 3, yellow 10, yellow 6

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 70 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest

Doesn't just mask,

neutralizes bad breath

CLEAN

BREATH

NET WT

2.5 OZ (70 g)

FLUORIDE TOOTHPASTE

FOR ANTICAVITY AND ANTIGINGIVITIS

SPEARMINT

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/01/00030772225882Screenshot 2026-04-10 135032.pdf.jpg
Data codeData Matrix21345840Screenshot 2026-04-10 135032.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
84126-642-03CrestClean Breath Spearmint3 in 1 CELLO PACKPASTE, DENTIFRICE31
84126-642-03CrestClean Breath Spearmint1 in 1 CARTONPASTE, DENTIFRICE11
84126-642-25CrestClean Breath Spearmint70 g in 1 TUBEPASTE, DENTIFRICE701
84126-642-25CrestClean Breath Spearmint1 in 1 CARTONPASTE, DENTIFRICE11
84126-642-46CrestClean Breath Spearmint130 g in 1 TUBEPASTE, DENTIFRICE1301
84126-642-46CrestClean Breath Spearmint1 in 1 CARTONPASTE, DENTIFRICE11

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-64284126-642-25, 84126-642-46, 84126-642-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN 33P3ONR6O1SIACT
YELLOW 6H77VEI93A8IACT
YELLOW 1035SW5USQ3GIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
STANNOUS CHLORIDE1BQV3749L5IACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ZINC CITRATEK72I3DEX9BIACT
MICAV8A1AW0880IACT
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 Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f20343e-6c03-48e8-e063-6294a90a8cdf2026-04-10WarningsExact identifier
ndc (package): 84126-642-03
ndc (package): 84126-642-46
ndc (package): 84126-642-25
ndc (product): 84126-642
ndc11 (package): 84126064225
ndc11 (package): 84126064203
ndc11 (package): 84126064246
spl id: 4f202b87-9a3c-437c-e063-6394a90a8fab
spl set id: 4f20343e-6c03-48e8-e063-6294a90a8cdf

Reported adverse events (FAERS/openFDA)#

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