Antispetic

Product NDC
55319-664
11-digit product format
553190664
Labeler code
55319
Product ID
55319-664_4b935ea8-06ad-a5e6-e063-6294a90a65d1
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Family Dollar Stores, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-11
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
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
55319-664-12Antispetic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150015
55319-664-13Antispetic1250 mL in 1 BOTTLE, PLASTICMOUTHWASH125015
55319-664-69Antispetic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25015
55319-664-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-664ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [FAMILY DOLLAR SERVICES, INC]14Current NDC, Legacy NDC, 4 package rows20250502_7b6563bc-8aa7-48ea-bf1c-5d5a5ee2d381.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 % MouthwashPSN7b6563bc-8aa7-48ea-bf1c-5d5a5ee2d38115
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD7b6563bc-8aa7-48ea-bf1c-5d5a5ee2d38115
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY7b6563bc-8aa7-48ea-bf1c-5d5a5ee2d38115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-664-12553190664121500 mL in 1 BOTTLE, PLASTIC (55319-664-12) 1500 ml2023-11-07NoNoHistorical
55319-664-13553190664131250 mL in 1 BOTTLE, PLASTIC (55319-664-13) 1250 ml2011-01-110000-00-00NoNoCurrent
55319-664-6955319066469250 mL in 1 BOTTLE, PLASTIC (55319-664-69) 250 ml2011-01-110000-00-00NoNoCurrent
55319-664-86553190664861000 mL in 1 BOTTLE, PLASTIC (55319-664-86) 1000 ml2011-01-110000-00-00NoNoCurrent