FDA.reportPublic FDA data

Antispetic

Product NDC
30142-664
11-digit product format
301420664
Labeler code
30142
Product ID
30142-664_4bd17475-ef8c-b7a1-e063-6294a90a4740
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
The Kroger Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1994-08-05
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
Antispetic
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
30142-664-12Antispetic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150024
30142-664-19Antispetic94 mL in 1 BOTTLE, PLASTICMOUTHWASH9424
30142-664-77Antispetic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50024
30142-664-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100024

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
THYMOLACTIVE MOIETY3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-664ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KROGER CO.]22Current NDC, Legacy NDC, 4 package rows20250209_e4844ad3-6073-4c2c-9029-5c4f4ea024e8.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 % MouthwashPSNe4844ad3-6073-4c2c-9029-5c4f4ea024e824
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDe4844ad3-6073-4c2c-9029-5c4f4ea024e824
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYe4844ad3-6073-4c2c-9029-5c4f4ea024e824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-664-12301420664121500 mL in 1 BOTTLE, PLASTIC (30142-664-12) 1500 ml1994-08-050000-00-00NoNoCurrent
30142-664-193014206641994 mL in 1 BOTTLE, PLASTIC (30142-664-19) 94 ml1994-08-05NoNoCurrent
30142-664-7730142066477500 mL in 1 BOTTLE, PLASTIC (30142-664-77) 500 ml1994-08-050000-00-00NoNoCurrent
30142-664-86301420664861000 mL in 1 BOTTLE, PLASTIC (30142-664-86) 1000 ml2024-11-01NoNoCurrent