FDA.reportPublic FDA data

Mouthwash

Manufacturer
Orazen Inc
Effective date
2025-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:45

Label at a glance#

ProductMouthwash
Active ingredientMETHYL SALICYLATE, THYMOL, EUCALYPTOL, MENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

OTC - PURPOSE SECTION

Purpose
Antigingivitis, Antiplaque

INDICATIONS & USAGE SECTION

Uses
Helps reduce plaque that leads to

  • gingivitis
  • bleeding gums

WARNINGS SECTION

Warnings

Stop use and see your dentist immediately 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 increasing space between the teeth

These may be signs or 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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

adult and children 12 years of age and oldervigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
children 6 to 20 years of agesupervise use
children uner 6 years of agedo not use

OTHER SAFETY INFORMATION

Other information

  • not intended to replace brushing or flossing
  • store at room temperature (59-77F)
  • cold weather may cloud this product, but will not affect its antiseptic properties.

INACTIVE INGREDIENT SECTION

Inactive ingredients
alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN2
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD2
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY2

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
71927-006-012025-04-07C16284748780-12cef2736-7d13-d83d-e063-dadaa90ab31f71927-006
71927-006-012025-01-30C16284748780-12cef2736-7d13-d83d-e063-dadaa90ab31f71927-006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-006-01Mouthwash251 mL in 1 BOTTLELIQUID2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-006MOUTHWASH (MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [ORAZEN INC]2Current NDC, Legacy NDC, 1 package rows20250409_873c43df-1d46-359b-e053-2a91aa0a4319.zip

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
71927-00671927-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
EUCALYPTOLRV6J6604TKACTIB
FD&C GREEN NO. 33P3ONR6O1SIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
MouthwashMENTHOL, METHYL SALICYLATE, THYMOLOrazen Inc873c43df-1d46-359b-e053-2a91aa0a43192025-04-07WarningsExact identifier
ndc (package): 71927-006-01
ndc (product): 71927-006
ndc11 (package): 71927000601
spl id: 323a2253-01b0-de24-e063-6394a90ae0d7
spl set id: 873c43df-1d46-359b-e053-2a91aa0a4319

Reported adverse events (FAERS/openFDA)#

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