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
full-release
Hydrated at
2026-06-01 01:32:07

Label at a glance#

ProductCrest 3D White 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, cellulose gum, sodium hydroxide, 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 - 116 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPROVED FORMULA

Crest®

3D WHITE™

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 4.1 OZ (116 g)

ENAMEL SAFE WHITENING

Removes up to
80% of surface stains
EVEN IN HARD TO REACH PLACES

CHARCOAL

A FORMULA TO ACTIVATE A WHITER SMILE*

945945

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-945-02Crest 3D WhiteCharcoal2 in 1 CELLO PACKPASTE, DENTIFRICE210
37000-945-02Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-03Crest 3D WhiteCharcoal3 in 1 CELLO PACKPASTE, DENTIFRICE310
37000-945-03Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-27Crest 3D WhiteCharcoal76 g in 1 TUBEPASTE, DENTIFRICE7610
37000-945-27Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-30Crest 3D WhiteCharcoal85 g in 1 TUBEPASTE, DENTIFRICE8510
37000-945-30Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-38Crest 3D WhiteCharcoal108 g in 1 TUBEPASTE, DENTIFRICE10810
37000-945-38Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-41Crest 3D WhiteCharcoal116 g in 1 TUBEPASTE, DENTIFRICE11610
37000-945-41Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-76Crest 3D WhiteCharcoal1 in 1 CARTONPASTE, DENTIFRICE110
37000-945-76Crest 3D WhiteCharcoal2 in 1 CELLO PACKPASTE, DENTIFRICE210
37000-945-82Crest 3D WhiteCharcoal116 g in 1 TUBEPASTE, DENTIFRICE11610
37000-945-82Crest 3D WhiteCharcoal2 in 1 CARTONPASTE, DENTIFRICE210

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
37000-94537000-945-02, 37000-945-30, 37000-945-41, 37000-945-03, 37000-945-82, 37000-945-27, 37000-945-76, 37000-945-38

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
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
MICAV8A1AW0880IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-12-10monthly-update2026-06-03 17:45:44

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 CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company96247083-39e9-7ca7-e053-2995a90a75d02026-01-08WarningsExact identifier
ndc (package): 37000-945-76
ndc (package): 37000-945-03
ndc (package): 37000-945-27
ndc (package): 37000-945-82
ndc (package): 37000-945-38
ndc (package): 37000-945-30
ndc (package): 37000-945-02
ndc (package): 37000-945-41
ndc (product): 37000-945
ndc11 (package): 37000094541
ndc11 (package): 37000094503
ndc11 (package): 37000094530
ndc11 (package): 37000094538
ndc11 (package): 37000094576
ndc11 (package): 37000094582
ndc11 (package): 37000094502
ndc11 (package): 37000094527
spl id: 47e2ff33-29d9-6dd9-e063-6394a90a5387
spl set id: 96247083-39e9-7ca7-e053-2995a90a75d0

Reported adverse events (FAERS/openFDA)#

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