FDA.reportPublic FDA data

Mouthwash

Product NDC
53943-514
11-digit product format
539430514
Labeler code
53943
Product ID
53943-514_51157b5f-583b-0fdd-e063-6394a90a1e3e
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
LIQUID
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-01
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
Mouthwash
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
3J50XA376EInternal UNII lookup
RV6J6604TKInternal 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
d00e472f-78f2-3d36-e053-2995a90ac267Available 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
53943-514-50Mouthwash1500 mL in 1 BOTTLE, PLASTICLIQUID15004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-514MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]3Current NDC, Legacy NDC, 1 package rows20241022_d00e472f-78f2-3d36-e053-2995a90ac267.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
MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDISCOUNT DRUG MARTd00e472f-78f2-3d36-e053-2995a90ac2672026-05-05WarningsExact identifier
ndc (product): 53943-514

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSNd00e472f-78f2-3d36-e053-2995a90ac2674
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDd00e472f-78f2-3d36-e053-2995a90ac2674
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYd00e472f-78f2-3d36-e053-2995a90ac2674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-514-50539430514501500 mL in 1 BOTTLE, PLASTIC (53943-514-50) 1500 ml2021-11-010000-00-00NoNoCurrent