Mouth Rinse

Product NDC
41163-318
11-digit product format
411630318
Labeler code
41163
Product ID
41163-318_4b074cd2-74ec-e8e8-e063-6394a90ae721
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Dosage form
MOUTHWASH
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-01-04
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-31841163-318-13DDiscontinued by firm2026-08-03

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, THYMOLUnited Natural Foods, Inc. dba UNFId9c48c72-b9df-4b3a-bc56-d887196521e22026-02-17Warnings, Adverse reactionsExact identifier
ndc (product): 41163-318

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
d9c48c72-b9df-4b3a-bc56-d887196521e2Available 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
41163-318-12Mouth Rinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150020
41163-318-13Mouth Rinse1250 mL in 1 BOTTLE, PLASTICMOUTHWASH125020
41163-318-77Mouth Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50020
41163-318-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
THYMOLACTIVE INGREDIENT3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
MENTHOLACTIVE MOIETYL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
THYMOLACTIVE MOIETY3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1
WATERINACTIVE INGREDIENT059QF0KO0RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SUPERVALU INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-318MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [UNITED NATURAL FOODS, INC. DBA UNFI]19Current NDC, Legacy NDC, 4 package rows20250417_d9c48c72-b9df-4b3a-bc56-d887196521e2.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 % MouthwashPSNd9c48c72-b9df-4b3a-bc56-d887196521e220
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDd9c48c72-b9df-4b3a-bc56-d887196521e220
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYd9c48c72-b9df-4b3a-bc56-d887196521e220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-318-12411630318121500 mL in 1 BOTTLE, PLASTIC (41163-318-12) 1500 ml2005-01-040000-00-00NoNoCurrent
41163-318-13411630318131250 mL in 1 BOTTLE, PLASTIC (41163-318-13) 1250 ml2005-01-040000-00-00NoNoCurrent
41163-318-7741163031877500 mL in 1 BOTTLE, PLASTIC (41163-318-77) 500 ml2005-01-040000-00-00NoNoCurrent
41163-318-86411630318861000 mL in 1 BOTTLE, PLASTIC (41163-318-86) 1000 ml2005-01-040000-00-00NoNoCurrent