FDA.reportPublic FDA data

Antiseptic Mouth Rinse

Product NDC
67091-106
Requested package NDC
67091-106-33
11-digit product format
670910106
Labeler code
67091
Product ID
67091-106_4aa25068-be77-c8a7-e063-6294a90a1810
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
WinCo Foods, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-03
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
.92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic Mouth Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUCALYPTOL.92 mg/mL
MENTHOL.42 mg/mL
METHYL SALICYLATE.6 mg/mL
THYMOL.64 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ad7818e-caee-49f0-81e8-bda6fbd64ea5Available on FDA.report

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
67091-106-33Antiseptic Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-106ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WINCO FOODS, LLC]14Current NDC, Legacy NDC, 1 package rows20250426_4ad7818e-caee-49f0-81e8-bda6fbd64ea5.zip

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
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC4ad7818e-caee-49f0-81e8-bda6fbd64ea52026-02-12Warnings, Adverse reactionsExact identifier
ndc (package): 67091-106-33
ndc (product): 67091-106
ndc11 (package): 67091010633

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN4ad7818e-caee-49f0-81e8-bda6fbd64ea515
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD4ad7818e-caee-49f0-81e8-bda6fbd64ea515
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY4ad7818e-caee-49f0-81e8-bda6fbd64ea515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-106-33670910106331000 mL in 1 BOTTLE, PLASTIC (67091-106-33) 1000 ml2014-10-030000-00-00NoNoCurrent