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
8
Source
monthly-update
Hydrated at
2026-06-03 17:52:29

Label at a glance#

ProductCrest Premium Plus Deep Clean 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

sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, xanthan gum. sodium saccharin, cellulose gum, carbomer, 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
ANTICAVITY FLUORIDE TOOTHPASTE

NET WT 7.2 OZ (204 g)
ACTIVE FOAM

+ WHITENING

DEEP CLEAN

WHITENS & PREVENTS TARTAR BUILDUP

foaming mint

994994

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN8
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD8
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY8
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY8
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY8
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-994-522024-02-06C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam
37000-994-522024-02-06C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam
37000-994-722024-02-06C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam
37000-994-722024-02-06C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam
37000-994-522024-01-30C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam
37000-994-522024-01-30C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam
37000-994-722024-01-30C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam
37000-994-722024-01-30C16284748780-11030e365-3c3e-111a-e063-dadaa90a10e2Crest Premium Plus Deep Clean Active Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-994-15Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-15Crest Premium PlusDeep Clean Active Foam3 in 1 CELLO PACKPASTE, DENTIFRICE38
37000-994-52Crest Premium PlusDeep Clean Active Foam147 g in 1 TUBEPASTE, DENTIFRICE1478
37000-994-52Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-72Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-72Crest Premium PlusDeep Clean Active Foam204 g in 1 TUBEPASTE, DENTIFRICE2048

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-99437000-994-72, 37000-994-52, 37000-994-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CARBOXYPOLYMETHYLENE0A5MM307FCIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-07-01full-release2026-06-01 01:06:17

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 Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
ndc (package): 37000-994-72
ndc (package): 37000-994-15
ndc (package): 37000-994-52
ndc (product): 37000-994
ndc11 (package): 37000099452
ndc11 (package): 37000099472
ndc11 (package): 37000099415
spl id: 47e347f8-eb74-9c1c-e063-6294a90ab479
spl set id: b851fe5c-d904-12da-e053-2a95a90a86f9

Reported adverse events (FAERS/openFDA)#

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