FDA.reportPublic FDA data

Crest 3D White

Manufacturer
Procter & Gamble Manfuacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-06-03 17:52:29

Label at a glance#

ProductCrest 3D White Brilliance Charcoal
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% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

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

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, charcoal powder, sucralose, polysorbate 80, mica, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 130 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LARGE SIZE

CREST 3D WHITE

NEW WT 4.6 OZ (130 g)

FLUORIDE ANTICAVITY TOOTHPASTE

ENAMEL SAFE

BRILLIANCE

CHARCOAL MINT

EXTRA STRENGTH WHITENING

WHITER TEETH IN 3 DAYS

ArtworkArtwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN10
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD10
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY10
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY10
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY10
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21192153CREST 3D WHITE CHARCOAL.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-989-352024-01-30C16284748780-11030e364-f9a8-111a-e063-dadaa90a10e2Crest 3D White Brilliance Charcoal Mint
37000-989-352024-01-30C16284748780-11030e364-f9a8-111a-e063-dadaa90a10e2Crest 3D White Brilliance Charcoal Mint
37000-989-392024-01-30C16284748780-11030e364-f9a8-111a-e063-dadaa90a10e2Crest 3D White Brilliance Charcoal Mint
37000-989-392024-01-30C16284748780-11030e364-f9a8-111a-e063-dadaa90a10e2Crest 3D White Brilliance Charcoal Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-989-35Crest 3D WhiteBrilliance Charcoal99 g in 1 TUBEPASTE, DENTIFRICE9910
37000-989-35Crest 3D WhiteBrilliance Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-989-39Crest 3D WhiteBrilliance Charcoal110 g in 1 TUBEPASTE, DENTIFRICE11010
37000-989-39Crest 3D WhiteBrilliance Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-989-46Crest 3D WhiteBrilliance Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-989-46Crest 3D WhiteBrilliance Charcoal130 g in 1 TUBEPASTE, DENTIFRICE13010

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-98937000-989-39, 37000-989-35, 37000-989-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM HEXAMETAPHOSPHATEP1BM4ZH95LIACT
CARRAGEENAN5C69YCD2YJIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-08-20full-release2026-06-01 01:11:16

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 Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
ndc (package): 37000-989-39
ndc (package): 37000-989-46
ndc (package): 37000-989-35
ndc (product): 37000-989
ndc11 (package): 37000098935
ndc11 (package): 37000098946
ndc11 (package): 37000098939
spl id: 47e32c0d-afe7-af72-e063-6394a90af9cf
spl set id: b7882679-339c-554f-e053-2995a90afa7f

Reported adverse events (FAERS/openFDA)#

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