FDA.reportPublic FDA data

Mouth Rinse

Product NDC
59450-901
Requested package NDC
59450-901-86
11-digit product format
594500901
Labeler code
59450
Product ID
59450-901_4bd2154d-e552-b55c-e063-6394a90a88ec
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
The Kroger Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-21
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e2026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 59450-901-86
ndc (product): 59450-901
ndc11 (package): 59450090186

Additional Listing Data#

Finished product
Yes
Brand name base
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
f6ccdce2-ae3c-44f7-803d-5a135a7a7e8eAvailable 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
59450-901-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-901MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER]4Current NDC, 1 package rows20250411_f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSNf6ccdce2-ae3c-44f7-803d-5a135a7a7e8e6
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDf6ccdce2-ae3c-44f7-803d-5a135a7a7e8e6
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYf6ccdce2-ae3c-44f7-803d-5a135a7a7e8e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59450-901-86594500901861000 mL in 1 BOTTLE, PLASTIC (59450-901-86) 1000 ml2023-03-21NoNoCurrent