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
12
Source
monthly-update
Hydrated at
2026-06-03 17:51:42

Label at a glance#

ProductCrest Premium Plus Advanced Whitening 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

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

water, sorbitol, hydrated silica, disodium
pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum,
sodium saccharin, carbomer, polysorbate 80, mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 204 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest plus Premium with flip cap

NET WT 5.2 OZ (147 g)

ANTICAVITY FLUORIDE TOOTHPASTE

ACTIVE FOAM

ADVANCED

WHITENING

REMOVES 5X MORE STAINS

CLEAN MINT

LabelLabel

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90451994Capture.pdf.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-993-522023-03-31C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam
37000-993-522023-03-31C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam
37000-993-722023-03-31C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam
37000-993-722023-03-31C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam
37000-993-522023-01-30C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam
37000-993-522023-01-30C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam
37000-993-722023-01-30C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam
37000-993-722023-01-30C16284748780-1f386c64a-4242-0266-e053-dadaa90a7c1aCrest Premium Plus Advanced Whitening Active Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-993-35Crest Premium PlusAdvanced Whitening Active Foam3 in 1 CARTONPASTE, DENTIFRICE312
37000-993-35Crest Premium PlusAdvanced Whitening Active Foam147 g in 1 TUBEPASTE, DENTIFRICE14712
37000-993-52Crest Premium PlusAdvanced Whitening Active Foam147 g in 1 TUBEPASTE, DENTIFRICE14712
37000-993-52Crest Premium PlusAdvanced Whitening Active Foam1 in 1 CARTONPASTE, DENTIFRICE112
37000-993-72Crest Premium PlusAdvanced Whitening Active Foam1 in 1 CARTONPASTE, DENTIFRICE112
37000-993-72Crest Premium PlusAdvanced Whitening Active Foam204 g in 1 TUBEPASTE, DENTIFRICE20412

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
37000-99337000-993-72, 37000-993-52, 37000-993-35

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
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-08-20full-release2026-06-01 01:11:17

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 Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
ndc (package): 37000-993-52
ndc (package): 37000-993-72
ndc (package): 37000-993-35
ndc (product): 37000-993
ndc11 (package): 37000099335
ndc11 (package): 37000099352
ndc11 (package): 37000099372
spl id: 47e343c9-2e62-c288-e063-6394a90a0b5c
spl set id: b81a22dc-b759-24cd-e053-2995a90a9148

Reported adverse events (FAERS/openFDA)#

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