FDA.reportPublic FDA data

Sodium monofluorophosphate - The Procter & Gamble Manufacturing Company

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:16

Label at a glance#

ProductCrest 3D White Deep Stain Remover Brilliant White
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

adults and children 6 yrs. & 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.: ask a dentist

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 1.14%

(0.20% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

OTC - KEEP OUT OF REACH OF CHILDREN 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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 yrs. & 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.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, sodium hexametaphosphate, disodium
pyrophosphate, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, sodium saccharin,
cocamidopropyl betaine, phosphoric acid, sucralose, mica, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

Crest 3D White Brilliance 87g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 VALUE

PACK

Crest

3D WHITE

FLUORIDE ANTICAVITY TOOTHPASTE

DEEP STAIN REMOVER

BRILLIANT WHITE

WHITER

TEETH IN

1 DAY

BRILLIANT

WHITE

THE

PERFECT

DOSE IN

1 PUMP

2 - 3.1 OZ (87 g) TUBES EACH; TOTA NET WT 6.2 OZ (175 g)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSN1
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD1
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY1
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY1
1038995sodium monofluorophosphate 1.14 % ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codescan.pg.com/01/00030772189474Screenshot 2026-03-18 073902.pdf.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-626-03Crest 3D WhiteDeep Stain Remover Brilliant White87 g in 1 TUBEPASTE, DENTIFRICE871
84126-626-03Crest 3D WhiteDeep Stain Remover Brilliant White2 in 1 CARTONPASTE, DENTIFRICE21

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-62684126-626-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRATED SILICAY6O7T4G8P9IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
SODIUM HEXAMETAPHOSPHATEP1BM4ZH95LIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
CARRAGEENAN5C69YCD2YJIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SORBITOL506T60A25RIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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 3D White Deep Stain Remover Brilliant WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4e53a086-6cda-6460-e063-6394a90af1f32026-02-01Exact identifier
ndc (package): 84126-626-03
ndc (product): 84126-626
ndc11 (package): 84126062603
spl id: 4e53a2b3-78b9-54bf-e063-6394a90aab83
spl set id: 4e53a086-6cda-6460-e063-6394a90af1f3

Reported adverse events (FAERS/openFDA)#

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