FDA.reportPublic FDA data

Crest Premium Plus

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 17:52:20

Label at a glance#

ProductCrest Premium Plus Anti-Bacterial
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

aids in the prevention of cavities helps prevent gingivitis helps interfere with the harmful effects of plaque associated with gingivitis helps control plaque bacteria that contribute to the development of gingivitis

Dosage and administration

adults and children 12 yrs. & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 12 yrs.: ask a dentist

Storage and handling

products containing stannous fluoride may produce surface staining of the teeth adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist this Crest is specially formulated to help prevent staining see your dentist regularly

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, antigingivitis toothpaste

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 12 yrs. & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • do not swallow
  • children under 12 yrs.: ask a dentist

Other information

STORAGE AND HANDLING SECTION

  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • this Crest is specially formulated to help prevent staining
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, flavor, carrageenan, sodium citrate, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, stannous chloride, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 144 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest ® plus PREMIUM

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

NET WT 7.0 OZ (198 g)

ACTIVE FOAM +WHITENING

ANTI-BACTERIAL

HELPS KILL PLAQUE BACTERIA*

smooth peppermint

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN9
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD9
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY9
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY9
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90472405Capture.pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-992-522023-03-31C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial
37000-992-522023-03-31C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial
37000-992-702023-03-31C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial
37000-992-702023-03-31C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial
37000-992-522023-01-30C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial
37000-992-522023-01-30C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial
37000-992-702023-01-30C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial
37000-992-702023-01-30C16284748780-1f386c649-a78e-0266-e053-dadaa90a7c1aCrest Premium Plus Anti-Bacterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-992-52Crest Premium PlusAnti-Bacterial1 in 1 CARTONPASTE, DENTIFRICE19
37000-992-52Crest Premium PlusAnti-Bacterial147 g in 1 TUBEPASTE, DENTIFRICE1479
37000-992-70Crest Premium PlusAnti-Bacterial1 in 1 CARTONPASTE, DENTIFRICE19
37000-992-70Crest Premium PlusAnti-Bacterial198 g in 1 TUBEPASTE, DENTIFRICE1989

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-99237000-992-70, 37000-992-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC CITRATEK72I3DEX9BIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
STANNOUS CHLORIDE1BQV3749L5IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-01-14full-release2026-06-01 00:52:42

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 Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
ndc (package): 37000-992-52
ndc (package): 37000-992-70
ndc (product): 37000-992
ndc11 (package): 37000099270
ndc11 (package): 37000099252
spl id: 47e4ee55-548a-2976-e063-6294a90a9c09
spl set id: b7af946e-1cac-b8c0-e053-2a95a90afa4a

Reported adverse events (FAERS/openFDA)#

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