FDA.reportPublic FDA data

Assured

Manufacturer
Greenbrier International, Inc.
Effective date
2021-08-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:03

Label at a glance#

ProductAssured Oral Health Fresh Mint
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For better oral hygiene and fresher breath

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

Purpose

Antigingivitis, Antiplaque

INDICATIONS & USAGE SECTION

Usehelps control plaque that leads to gingivitis

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be symptoms of periodontitis, a serious form of gum disease.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 to under 12 years of age: supervise use
  • when used after brushing. rinse mouth with water first
  • children under 6 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • this rinse is not intended to replace brushing or flossing

INACTIVE INGREDIENT SECTION

Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

SPL UNCLASSIFIED SECTION

This rinse may cause temporary staining to the surface of the teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Proctor & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint.

DISTRIBUTED BY: GREENBRIER INTERNATIONAL INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARES TO ACTIVE INGREDIENTS OF CREST PRO-HEALTH®*

Assured™

FRESH MINT

ORAL HEALTH RINSE

MULTI-ACTION ALCOHOL-FREE ANTISEPTIC

ANTIGINGIVITIS / ANTIPLAQUE

Kills Germs that Cause Bad Breath, Plaque and the Gum Disease Gingivitis

Alcohol Free, Freshens Breath

16.9 FL OZ (500 mL)

Assured FM OH Rinse FrontAssured FM OH Rinse Front

Assured FM OH Rinse BackAssured FM OH Rinse Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN3
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD3
1100924cetylpyridinium chloride 0.07 % Oral RinseSY3

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-0320-72023-01-30C16284748780-1c7ccaba7-0f00-fd44-e053-dadaa90aa01bAssured Fresh Mint Oral Health Rinse
33992-0320-72021-08-23C16284748780-1c7ccaba7-0f00-fd44-e053-dadaa90aa01bAssured Fresh Mint Oral Health Rinse
33992-0320-72021-07-23C16284748780-1c7ccaba7-0f00-fd44-e053-dadaa90aa01bAssured Fresh Mint Oral Health Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-0320-7AssuredOral Health Fresh Mint500 mL in 1 BOTTLE, PLASTICRINSE5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-0320ASSURED ORAL HEALTH FRESH MINT (CETYLPYRIDINIUM CHLORIDE) RINSE [GREENBRIER INTERNATIONAL, INC.]3Legacy NDC, 1 package rows20210824_9571bc73-d1c5-4550-e053-2a95a90a886b.zip

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
33992-032033992-0320-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT
POLOXAMER 188LQA7B6G8JGIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT

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
ca3f1b08-986a-0e50-e053-2a95a90a8b459571bc73-d1c5-4550-e053-2a95a90a886b2021-08-23WarningsExact identifier
spl id: ca3f1b08-986a-0e50-e053-2a95a90a8b45
spl set id: 9571bc73-d1c5-4550-e053-2a95a90a886b

Reported adverse events (FAERS/openFDA)#

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