FDA.reportPublic FDA data

Crest Cavity Protection Cool Mint Gel

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:52:28

Label at a glance#

ProductCrest Plus Cavity Protection Cool Mint Gel
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, sodium lauryl sulfate, trisodium phosphate, cellulose gum, flavor, sodium phosphate, sodium saccharin, carbomer, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati OH 45202

www.crest.com

PRINCIPAL DISPLAY PANEL - 161 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADA
ACCEPTED
American
Dental
Association

Crest Plus

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 5.7 OZ (161 g)

CAVITY
PROTECTION

WITH ACTIVE FLUORIDE

Cool Mint Gel

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90441420ARTWORk pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-816-57Crest Plus Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE13
69423-816-57Crest Plus Cavity ProtectionCool Mint Gel161 g in 1 TUBEGEL, DENTIFRICE1613
69423-816-82Crest Plus Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE13
69423-816-82Crest Plus Cavity ProtectionCool Mint Gel232 g in 1 TUBEGEL, DENTIFRICE2323

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-81669423-816-82, 69423-816-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASICA752Q30A6XIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PHOSPHATESE337SVY37IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CARBOXYPOLYMETHYLENE0A5MM307FCIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-01-08full-release2026-06-01 00:51:18

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 Plus Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company0813171e-bda5-b004-e063-6394a90ad3642026-01-08WarningsExact identifier
ndc (package): 69423-816-57
ndc (package): 69423-816-82
ndc (product): 69423-816
ndc11 (package): 69423081657
ndc11 (package): 69423081682
spl id: 47e4ffad-8c7a-4b7f-e063-6294a90ae121
spl set id: 0813171e-bda5-b004-e063-6394a90ad364

Reported adverse events (FAERS/openFDA)#

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