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
13
Source
monthly-update
Hydrated at
2026-06-03 17:51:49

Label at a glance#

ProductCrest Premium Plus Scope Outlast Active Foam
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

sorbitol, water, hydrated silica, disodium pyrophosphate, flavor, sodium lauryl sulfate, sodium hydroxide, alcohol (0.7%), sodium saccharin, xanthan gum, glycerin, poloxamer 407, carbomer, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 204 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest

plus

PREMIUM

NET WT 7.2OZ (204 g)

ANTICAVITY FLUORIDE TOOTHPASTE

ACTIVE FOAM

+WHITENING
scope ®
OUTLAST®

KILLS UP TO 99.9% OF BAD BREATH GERMS*

long lasting mint

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN13
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD13
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY13
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY13
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY13
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY13

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90472364Capture.pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-991-03Crest Premium PlusScope Outlast Active Foam3 in 1 CELLO PACKPASTE, DENTIFRICE313
37000-991-03Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113
37000-991-04Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113
37000-991-04Crest Premium PlusScope Outlast Active Foam2 in 1 CELLO PACKPASTE, DENTIFRICE213
37000-991-52Crest Premium PlusScope Outlast Active Foam147 g in 1 TUBEPASTE, DENTIFRICE14713
37000-991-52Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113
37000-991-72Crest Premium PlusScope Outlast Active Foam204 g in 1 TUBEPASTE, DENTIFRICE20413
37000-991-72Crest Premium PlusScope Outlast Active Foam1 in 1 CARTONPASTE, DENTIFRICE113

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-99137000-991-72, 37000-991-52, 37000-991-03, 37000-991-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLOXAMER 407TUF2IVW3M2IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
ALCOHOL3K9958V90MIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM BENZOATEOJ245FE5EUIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
BENZOIC ACID8SKN0B0MIMIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM HYDROXIDE55X04QC32IIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-08-20full-release2026-06-01 01:11:16

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 Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
ndc (package): 37000-991-03
ndc (package): 37000-991-52
ndc (package): 37000-991-04
ndc (package): 37000-991-72
ndc (product): 37000-991
ndc11 (package): 37000099104
ndc11 (package): 37000099172
ndc11 (package): 37000099152
ndc11 (package): 37000099103
spl id: 47e3398c-efde-b995-e063-6394a90a2a9b
spl set id: b789587e-7f49-163a-e053-2a95a90a823f

Reported adverse events (FAERS/openFDA)#

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