FDA.reportPublic FDA data

Crest Pro-Health Gum Restore Smooth Mint

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:42

Label at a glance#

ProductCrest Pro-Health Gum Restore Smooth Mint
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Dosage and administration

use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a dentist ifsymptoms persist or condition worsens after regular use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
  • adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, flavor, poloxamer 407, sodium benzoate, zinc lactate,
sodium saccharin, sucralose, benzoic acid, red 33, green 3

Questions?

OTC - QUESTIONS SECTION

1-800-285-9139

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

Crest

PRO-HEALTH

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

GUM

RESTORE

24 HR

PROTECTION

WITH ADVANCED

COOLING TECHNOLOGY

Helps Reduce

Gum Inflammation

SMOOTH MINT

1 L (33.8 FL OZ)

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN1
1251371Crest Pro-Health 0.07 % Oral RinsePSN1
1251371cetylpyridinium chloride 0.7 MG/ML Mouthwash [Crest Mouthwash]SBD1
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD1
1100924cetylpyridinium chloride 0.07 % Oral RinseSY1
1251371Crest 0.07 % MouthwashSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codescan.pg.com/01/00037000558255Screenshot 2026-04-14 112856.pdf.jpg
Data codeData Matrix21316159Screenshot 2026-04-14 112856.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
84126-649-01Crest Pro-HealthGum Restore Smooth Mint1000 mL in 1 BOTTLE, PLASTICRINSE10001

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
84126-64984126-649-01

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
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ZINC LACTATE2GXR25858YIACT
RED 339DBA0SBB0LIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
POLOXAMER 407TUF2IVW3M2IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
GREEN 33P3ONR6O1SIACT
BENZOIC ACID8SKN0B0MIMIACT

Source Document#

Source XML

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 Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
ndc (package): 84126-649-01
ndc (product): 84126-649
ndc11 (package): 84126064901
spl id: 4f6e3b36-e566-7d27-e063-6294a90ae5ac
spl set id: 4f6e3b36-e565-7d27-e063-6294a90ae5ac

Reported adverse events (FAERS/openFDA)#

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