FDA.reportPublic FDA data

Eucalyptol, menthol, methyl salicylate, thymol

Product NDC
53942-855
11-digit product format
539420855
Labeler code
53942
Product ID
53942-855_49f11a3e-7722-ed2a-e063-6294a90a44ff
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Demoulas Super Markets, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-05
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
Eucalyptol, menthol, methyl salicylate, thymol
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
51748426-047a-4ecf-b0fe-205667c9ef08Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-855-12Eucalyptol, menthol, methyl salicylate, thymol1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-855EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH [DEMOULAS SUPER MARKETS, INC]3Current NDC, 1 package rows20250515_51748426-047a-4ecf-b0fe-205667c9ef08.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
Eucalyptol, menthol, methyl salicylate, thymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDemoulas Super Markets, Inc51748426-047a-4ecf-b0fe-205667c9ef082026-02-03Warnings, Adverse reactionsExact identifier
ndc (product): 53942-855

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN51748426-047a-4ecf-b0fe-205667c9ef084
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD51748426-047a-4ecf-b0fe-205667c9ef084
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY51748426-047a-4ecf-b0fe-205667c9ef084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53942-855-12539420855121500 mL in 1 BOTTLE, PLASTIC (53942-855-12) 1500 ml2023-06-05NoNoCurrent