FDA.reportPublic FDA data

Crest 3D White

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:51:34

Label at a glance#

ProductCrest 3D White Holiday Smile Deep Stain Remover and Whitestrips
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 2.1oz Tube of Toothpaste and 5 Whitening Treatments

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest

3DWHITE

HOLIDAY

SMILE

5 DAY

TEETH WHITENING GIFT BOX

DEEP STAIN REMOVER

DAILY TOOTHPASTE

+

3D WHITESTRIPS

1 TUBE TOOTHPASTE NET WT 2.1OZ (59g);

5 WHITENING TREATMENTS (EACH WITH 1 UPPER/1 LOWER STRIP) = 10 STRIPS

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSN2
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD2
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY2
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY2
1038995sodium monofluorophosphate 1.14 % ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-617-01Crest 3D WhiteHoliday Smile Deep Stain Remover and Whitestrips1 in 1 CARTONKIT12

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-61784126-617-01
84126-61184126-611-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HEXAMETAPHOSPHATEP1BM4ZH95LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM SACCHARINSB8ZUX40TYIACT
PHOSPHORIC ACIDE4GA8884NNIACT
MICAV8A1AW0880IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
TITANIUM DIOXIDE15FIX9V2JPIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
DISODIUM PYROPHOSPHATEH5WVD9LZUDIACT
CARRAGEENAN5C69YCD2YJIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PVPFZ989GH94EINGR
WATER059QF0KO0RINGR
HYDROGEN PEROXIDEBBX060AN9VINGR
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKINGR
SODIUM SACCHARINSB8ZUX40TYINGR
SODIUM HYDROXIDE55X04QC32IINGR
PEG-8B697894SGQINGR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-14full-release2026-06-01 01:11:05

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
ndc (product): 84126-611
Crest 3D White Holiday Smile Deep Stain Remover and WhitestripsSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company3c57d487-a3c7-b238-e063-6294a90aed812026-01-08Exact identifier
ndc (package): 84126-611-01
ndc (package): 84126-617-01
ndc (product): 84126-617
ndc11 (package): 84126061701
ndc11 (package): 84126061101
spl id: 47e545f2-5586-c805-e063-6294a90a0980
spl set id: 3c57d487-a3c7-b238-e063-6294a90aed81

Reported adverse events (FAERS/openFDA)#

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