FDA.reportPublic FDA data

Crest 3D White

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
monthly-update
Hydrated at
2026-06-03 17:52:26

Label at a glance#

ProductCrest 3D White Stain Shield
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% (0.16% 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

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPROVED FORMULA

Crest®
3D WHITE™

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 3.8 OZ (107 g)

ENAMEL SAFE WHITENING


STAIN SHIELD

Removes up to
90% of surface stains

STARTS WHITENING

AFTER 1 BRUSH

LabelLabel

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
37000-938-022023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-022023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-022023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-382023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-382023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-382023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-412023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-412023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-412023-03-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-022023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-022023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-022023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-382023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-382023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-382023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-412023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-412023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD
37000-938-412023-01-30C16284748780-1f386c649-e2c2-0266-e053-dadaa90a7c1aCrest ® 3D White™ STAIN SHIELD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-938-02Crest 3D WhiteStain Shield116 g in 1 TUBEPASTE, DENTIFRICE1169
37000-938-02Crest 3D WhiteStain Shield2 in 1 CARTONPASTE, DENTIFRICE29
37000-938-38Crest 3D WhiteStain Shield1 in 1 CARTONPASTE, DENTIFRICE19
37000-938-38Crest 3D WhiteStain Shield107 g in 1 TUBEPASTE, DENTIFRICE1079
37000-938-41Crest 3D WhiteStain Shield116 g in 1 TUBEPASTE, DENTIFRICE1169
37000-938-41Crest 3D WhiteStain Shield1 in 1 CARTONPASTE, DENTIFRICE19

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-93837000-938-41, 37000-938-02, 37000-938-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
GLYCERINPDC6A3C0OXIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-10-09monthly-update2026-06-03 17:37:57
72025-01-08full-release2026-06-01 00:51:31

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 Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960fef18-4533-5250-e053-2995a90aaf762026-01-08WarningsExact identifier
ndc (package): 37000-938-02
ndc (package): 37000-938-41
ndc (package): 37000-938-38
ndc (product): 37000-938
ndc11 (package): 37000093838
ndc11 (package): 37000093802
ndc11 (package): 37000093841
spl id: 47e4c6e7-4fb6-f03c-e063-6294a90a5437
spl set id: 960fef18-4533-5250-e053-2995a90aaf76

Reported adverse events (FAERS/openFDA)#

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