FDA.reportPublic FDA data

Crest

Manufacturer
Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
monthly-update
Hydrated at
2026-06-03 17:52:33

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, trisodium phosphate, flavor, sodium phosphate, cellulose gum, sodium saccharin, carbomer, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY

PROCTER & GAMBLE,

CINCINNATI, OH 45202

MADE IN MEXICO

PRINCIPAL DISPLAY PANEL - 68 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEANS & WHITENS TEETH*

Crest®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 2.4 OZ (68 g)

FRESH AND

WHITE

Peppermint

GLEEM™ Paste

ArtworkArtwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN9
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD9
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY9
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY9
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY9
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58933-868-022023-05-15C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White
58933-868-022023-05-15C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White
58933-868-022023-01-30C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White
58933-868-022023-01-30C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White
58933-868-022021-06-10C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White
58933-868-022021-06-10C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White
58933-868-022021-01-29C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White
58933-868-022021-01-29C16284748780-1ba0f9c33-137d-a910-e053-dadaa90a0b85Crest ® Fresh and White

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-868-02CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE19
58933-868-02CrestFresh and White82 g in 1 TUBEPASTE, DENTIFRICE829
58933-868-24CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE19
58933-868-24CrestFresh and White68 g in 1 TUBEPASTE, DENTIFRICE689

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58933-86858933-868-02, 58933-868-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-01-07full-release2026-06-01 01:31:45

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 FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5a1bb1fb-12a5-5fd1-e053-2991aa0a628b2026-01-08WarningsExact identifier
ndc (package): 58933-868-02
ndc (package): 58933-868-24
ndc (product): 58933-868
ndc11 (package): 58933086824
ndc11 (package): 58933086802
spl id: 47e55ea2-1115-0daa-e063-6394a90ababc
spl set id: 5a1bb1fb-12a5-5fd1-e053-2991aa0a628b

Reported adverse events (FAERS/openFDA)#

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