FDA.reportPublic FDA data

Crest 3D White

Manufacturer
Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:03

Label at a glance#

ProductCrest 3D White Fresh Mint
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

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

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1, polysorbate 80

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 65 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest®

3D WHITE™

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT

2.3 OZ (65 g)

ENAMEL SAFE WHITENING

STAIN ERASER

FRESH MINT

CLEANS AWAY STUBBORN STAINS INCLUDING:

COFFEE, SODA, TEA, WINE

artworkartwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN5
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD5
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY5
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY5
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY5
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-881-23Crest 3D WhiteFresh Mint1 in 1 CARTONPASTE, DENTIFRICE15
58933-881-23Crest 3D WhiteFresh Mint65 g in 1 TUBEPASTE, DENTIFRICE655

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58933-88158933-881-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM LAURYL SULFATE368GB5141JIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-13full-release2026-06-01 01:10:17

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 Fresh MintSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f27a63-15f3-cee4-e063-6394a90afa3b2026-01-08WarningsExact identifier
ndc (package): 58933-881-23
ndc (product): 58933-881
ndc11 (package): 58933088123
spl id: 47e557c1-ab4c-0c31-e063-6394a90adad8
spl set id: 01f27a63-15f3-cee4-e063-6394a90afa3b

Reported adverse events (FAERS/openFDA)#

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