FDA.reportPublic FDA data

Mouth Rinse

Product NDC
30142-072
11-digit product format
301420072
Labeler code
30142
Product ID
30142-072_4bd02fca-4526-bb4e-e063-6294a90a3d8d
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL
Dosage form
MOUTHWASH
Route
ORAL
Labeler
The Kroger Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-11-11
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
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 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
30142-072-12Mouth Rinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150020
30142-072-77Mouth Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50020
30142-072-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
THYMOLACTIVE INGREDIENT3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
EUCALYPTOLACTIVE MOIETYRV6J6604TKMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
MENTHOLACTIVE MOIETYL7T10EIP3AMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
THYMOLACTIVE MOIETY3J50XA376EMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
SORBITOLINACTIVE INGREDIENT506T60A25RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2
WATERINACTIVE INGREDIENT059QF0KO0RMOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-072MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL) MOUTHWASH [KROGER]18Current NDC, Legacy NDC, 3 package rows20250308_d97cdb55-c6bc-4138-ad1d-c7124d7f5cec.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 % MouthwashPSNd97cdb55-c6bc-4138-ad1d-c7124d7f5cec20
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDd97cdb55-c6bc-4138-ad1d-c7124d7f5cec20
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYd97cdb55-c6bc-4138-ad1d-c7124d7f5cec20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-072-12301420072121500 mL in 1 BOTTLE, PLASTIC (30142-072-12) 1500 ml1989-11-110000-00-00NoNoCurrent
30142-072-7730142007277500 mL in 1 BOTTLE, PLASTIC (30142-072-77) 500 ml1989-11-110000-00-00NoNoCurrent
30142-072-86301420072861000 mL in 1 BOTTLE, PLASTIC (30142-072-86) 1000 ml1989-11-110000-00-00NoNoCurrent