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
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:05

Label at a glance#

ProductCrest 3D White Advanced Whitening
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, sodium lauryl sulfate, cocamidopropyl betaine, trisodium phosphate, carrageenan, sodium saccharin, PEG-20M, xanthan gum, sucralose, mica, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 147 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest ®

3D WHITE™
FLUORIDE ANTICAVITY TOOTHPASTE

REMOVES UP TO 100% OF STAINS*

WHITER TEETH IN 3 DAYS

ADVANCED WHITENING

*surface stains

NET WT 5.2 OZ (147 g)

6942385369423853

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN7
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD7
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY7
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY7
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY7
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-853-05Crest 3D WhiteAdvanced Whitening5 in 1 CELLO PACKPASTE, DENTIFRICE57
69423-853-05Crest 3D WhiteAdvanced Whitening1 in 1 CARTONPASTE, DENTIFRICE17
69423-853-52Crest 3D WhiteAdvanced Whitening147 g in 1 TUBEPASTE, DENTIFRICE1477
69423-853-52Crest 3D WhiteAdvanced Whitening1 in 1 CARTONPASTE, DENTIFRICE17

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
69423-85369423-853-52, 69423-853-05

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
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
POLYETHYLENE OXIDE 90000016P9295IILIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-10-09monthly-update2026-06-03 17:38:42
52025-07-31full-release2026-06-01 01:09:06

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 Advanced WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd218ddc0-1d5f-f39b-e053-2995a90a96ed2026-01-08WarningsExact identifier
ndc (package): 69423-853-05
ndc (package): 69423-853-52
ndc (product): 69423-853
ndc11 (package): 69423085305
ndc11 (package): 69423085352
spl id: 47e3b94b-a5a6-644a-e063-6294a90ac248
spl set id: d218ddc0-1d5f-f39b-e053-2995a90a96ed

Reported adverse events (FAERS/openFDA)#

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