FDA.reportPublic FDA data

Crest

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:22

Label at a glance#

ProductCrest Fresh and White
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

sorbitol, water, hydrated silica, sodium lauryl sulfate, flavor, trisodium phosphate, cellulose gum, sodium saccharin, sodium phosphate,
carbomer, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

Distr. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 161 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEANS AND WHITENS TEETH*

Crest®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 5.7 oz (161 g)

FRESH AND WHITE

Peppermint

GLEEM™ Paste

Crest Fresh and WhiteCrest Fresh and White

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-897-24CrestFresh and White68 g in 1 TUBEPASTE, DENTIFRICE685
69423-897-24CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-29CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-29CrestFresh and White82 g in 1 TUBEPASTE, DENTIFRICE825
69423-897-57CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-57CrestFresh and White161 g in 1 TUBEPASTE, DENTIFRICE1615
69423-897-64CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-64CrestFresh and White181 g in 1 TUBEPASTE, DENTIFRICE1815

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-89769423-897-64, 69423-897-24, 69423-897-29, 69423-897-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM PHOSPHATESE337SVY37IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-06full-release2026-06-01 01:09:35

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 Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
ndc (package): 69423-897-57
ndc (package): 69423-897-64
ndc (package): 69423-897-29
ndc (package): 69423-897-24
ndc (product): 69423-897
ndc11 (package): 69423089729
ndc11 (package): 69423089764
ndc11 (package): 69423089724
ndc11 (package): 69423089757
spl id: 47e4bcee-5026-eff8-e063-6294a90a9a3c
spl set id: f9b31f6b-6b3f-abe0-e053-6294a90acb25

Reported adverse events (FAERS/openFDA)#

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