FDA.reportPublic FDA data

Crest Complete plus Whitening

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 17:51:51

Label at a glance#

ProductCrest Complete plus Whitening
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, polysorbate 80, citric acid, sodium benzoate, potassium sorbate, mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 153 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest Complete plus Extra WhiteningCrest Complete plus Extra WhiteningCrest ® plus

complete

NET WT/PESO NETO 5.4 OZ (153 g)

FLUORIDE TOOTHPASTE / PASTA DENTAL CON FLUORURO

EXTRA WHITENING

with tartar protection

A WHITER SMILE IN ONE TUBE*

clean mint

menta refrescante

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2585483sodium fluoride 0.234 % ToothpastePSN5
2585483sodium fluoride 0.00234 MG/MG ToothpasteSCD5
2585483sodium fluoride 0.234 % ToothpasteSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90345766ART90259446.jpg.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-894-54Crest Complete plus Whitening1 in 1 CARTONPASTE, DENTIFRICE15
69423-894-54Crest Complete plus Whitening153 g in 1 TUBEPASTE, DENTIFRICE1535

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
69423-89469423-894-54

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MICAV8A1AW0880IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SORBITOL506T60A25RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM HYDROXIDE55X04QC32IIACT
POLYSORBATE 806OZP39ZG8HIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-01-08full-release2026-06-01 00:51:38

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 Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
ndc (package): 69423-894-54
ndc (product): 69423-894
ndc11 (package): 69423089454
spl id: 47e4b6a0-2e39-3e5f-e063-6394a90afe71
spl set id: e3b1f139-4fe8-f005-e053-2995a90a53b4

Reported adverse events (FAERS/openFDA)#

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