FDA.reportPublic FDA data

Crest

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:52:05

Label at a glance#

ProductCrest 4in1
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

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, sodium phosphate, carbomer, sodium saccharin, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 68 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELPS PREVENT CAVITIES

Crest

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 2.4 OZ (68 g)

4in1

Whitens

Protects

Freshens

Cleans

Paste

6942385269423852

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN6
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD6
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-852-24Crest4in168 g in 1 TUBEPASTE, DENTIFRICE686
69423-852-24Crest4in11 in 1 CARTONPASTE, DENTIFRICE16

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-85269423-852-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATESE337SVY37IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SODIUM LAURYL SULFATE368GB5141JIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-07-31full-release2026-06-01 01:09:05

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 4in1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyce545406-3c4f-1ba7-e053-2a95a90a91ac2026-01-08WarningsExact identifier
ndc (package): 69423-852-24
ndc (product): 69423-852
ndc11 (package): 69423085224
spl id: 47e3b7c7-6aca-6a90-e063-6294a90a4cfe
spl set id: ce545406-3c4f-1ba7-e053-2a95a90a91ac

Reported adverse events (FAERS/openFDA)#

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