FDA.reportPublic FDA data

Oral Care Antiseptic

Product NDC
11822-3108
11-digit product format
118223108
Labeler code
11822
Product ID
11822-3108_49a03f49-5a1b-dedd-e063-6394a90aa724
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Rite Aid Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-10-15
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-310811822-3108-0DDiscontinued by firm2026-08-03

Additional Listing Data#

Finished product
Yes
Brand name base
Oral Care Antiseptic
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
c15b31be-a662-4c22-b4a7-66baed20868aAvailable 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
11822-3108-0Oral Care Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50019
11822-3108-2Oral Care Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100019

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
THYMOLACTIVE INGREDIENT3J50XA376EORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
MENTHOLACTIVE MOIETYL7T10EIP3AORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
THYMOLACTIVE MOIETY3J50XA376EORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1
WATERINACTIVE INGREDIENT059QF0KO0RORAL CARE ANTISEPTIC (EUCALYPTOL) MOUTHWASH [RITE AID]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3108ORAL CARE ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [RITE AID]18Current NDC, Legacy NDC, 2 package rows20250104_c15b31be-a662-4c22-b4a7-66baed20868a.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
Oral Care AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRite Aid Corporationc15b31be-a662-4c22-b4a7-66baed20868a2026-01-30Warnings, Adverse reactionsExact identifier
ndc (product): 11822-3108

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSNc15b31be-a662-4c22-b4a7-66baed20868a19
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDc15b31be-a662-4c22-b4a7-66baed20868a19
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYc15b31be-a662-4c22-b4a7-66baed20868a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3108-011822310800500 mL in 1 BOTTLE, PLASTIC (11822-3108-0) 500 ml1990-10-150000-00-00NoNoCurrent
11822-3108-2118223108021000 mL in 1 BOTTLE, PLASTIC (11822-3108-2) 1000 ml1990-10-150000-00-00NoNoCurrent