FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiRV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E
Rxcui1043619

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

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