Rinse

Product NDC
0363-0318
11-digit product format
003630318
Labeler code
0363
Product ID
0363-0318_4aa4918b-13cd-07a6-e063-6394a90aa6e8
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, Methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Walgreen Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-05-15
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-03180363-0318-69DDiscontinued by firm2026-08-17
excluded packagepackage0363-03180363-0318-88DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050363-0318-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0318-69d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260363-0318-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0318-69f5e01cc5f278…a2eaf40c39c3…

Additional Listing Data#

Finished product
Yes
Brand name base
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
5cb2eabe-46f2-48c0-9a4c-6518513ed34fAvailable 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
0363-0318-69Rinse250 mL in 1 BOTTLE, PLASTICMOUTHWASH25018
0363-0318-86Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100018
0363-0318-88Rinse2000 mL in 1 BOTTLE, PLASTICMOUTHWASH200018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
THYMOLACTIVE INGREDIENT3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
EUCALYPTOLACTIVE MOIETYRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
MENTHOLACTIVE MOIETYL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
THYMOLACTIVE MOIETY3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2
WATERINACTIVE INGREDIENT059QF0KO0RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0318RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [WALGREEN CO]17Current NDC, Legacy NDC, 3 package rows20250425_5cb2eabe-46f2-48c0-9a4c-6518513ed34f.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
RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreen Co.5cb2eabe-46f2-48c0-9a4c-6518513ed34f2026-02-12Warnings, Adverse reactionsExact identifier
ndc (product): 0363-0318

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN5cb2eabe-46f2-48c0-9a4c-6518513ed34f18
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD5cb2eabe-46f2-48c0-9a4c-6518513ed34f18
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY5cb2eabe-46f2-48c0-9a4c-6518513ed34f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0318-6900363031869250 mL in 1 BOTTLE, PLASTIC (0363-0318-69) 250 ml1990-05-150000-00-00NoNoCurrent
0363-0318-86003630318861000 mL in 1 BOTTLE, PLASTIC (0363-0318-86) 1000 ml1990-05-150000-00-00NoNoCurrent
0363-0318-88003630318882000 mL in 1 BOTTLE, PLASTIC (0363-0318-88) 2000 ml1990-05-150000-00-00NoNoCurrent