FDA.reportPublic FDA data

Crest Tartar Protection

Manufacturer
Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
monthly-update
Hydrated at
2026-06-03 17:51:46

Label at a glance#

ProductCrest Tartar Protection
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, disodium pyrophosphate, sodium hydroxide, sodium lauryl sulfate, flavor, xanthan gum, sodium saccharin, carbomer, cellulose gum, 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 - 161 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELPS PREVENT TARTAR & CAVITIES

Crest®

ADA

Accepted

American

Dental

Association ®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 5.7 OZ (161 g)

TARTAR

PROTECTION

Regular PasteTartar ProtectionTartar Protection

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN12
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD12
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY12
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY12
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY12
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY12

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58933-008-022023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-022023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-572023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-572023-05-17C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-022023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-022023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-572023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-572023-01-30C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-022021-06-10C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-022021-06-10C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032021-06-10C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032021-06-10C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042021-06-10C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042021-06-10C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-022021-01-29C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-022021-01-29C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032021-01-29C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-032021-01-29C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042021-01-29C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection
58933-008-042021-01-29C16284748780-1ba0f9c33-518c-a910-e053-dadaa90a0b85Crest ® Tartar Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-008-02Crest Tartar Protection82 g in 1 TUBEPASTE, DENTIFRICE8212
58933-008-02Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-03Crest Tartar Protection130 g in 1 TUBEPASTE, DENTIFRICE13012
58933-008-03Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-04Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-04Crest Tartar Protection181 g in 1 TUBEPASTE, DENTIFRICE18112
58933-008-24Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112
58933-008-24Crest Tartar Protection68 g in 1 TUBEPASTE, DENTIFRICE6812
58933-008-57Crest Tartar Protection161 g in 1 TUBEPASTE, DENTIFRICE16112
58933-008-57Crest Tartar Protection1 in 1 CARTONPASTE, DENTIFRICE112

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
58933-00858933-008-02, 58933-008-03, 58933-008-04, 58933-008-57, 58933-008-24

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
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-12-17full-release2026-06-01 01:26:25

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 Tartar ProtectionSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5940711d-71b7-cb7d-e053-2a91aa0aef182026-01-08WarningsExact identifier
ndc (package): 58933-008-57
ndc (package): 58933-008-24
ndc (package): 58933-008-04
ndc (package): 58933-008-03
ndc (package): 58933-008-02
ndc (product): 58933-008
ndc11 (package): 58933000803
ndc11 (package): 58933000804
ndc11 (package): 58933000802
ndc11 (package): 58933000857
ndc11 (package): 58933000824
spl id: 47e54e5e-4bd4-00ce-e063-6394a90a99e8
spl set id: 5940711d-71b7-cb7d-e053-2a91aa0aef18

Reported adverse events (FAERS/openFDA)#

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