Antispetic

Product NDC
11344-664
11-digit product format
113440664
Labeler code
11344
Product ID
11344-664_5259f5c3-2a76-a2e7-e063-6394a90a4643
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Nice-Pak Products, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-07-15
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
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
11344-664-12Antispetic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15006
11344-664-69Antispetic250 mL in 1 BOTTLE, PLASTICMOUTHWASH2506
11344-664-77Antispetic500 mL in 1 BOTTLE, PLASTICMOUTHWASH5006
11344-664-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-664ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC]4Current NDC, 4 package rows20250514_da4a0e82-b97e-4515-98c6-2c998164a247.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 % MouthwashPSNda4a0e82-b97e-4515-98c6-2c998164a2476
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDda4a0e82-b97e-4515-98c6-2c998164a2476
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYda4a0e82-b97e-4515-98c6-2c998164a2476

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-664-12113440664121500 mL in 1 BOTTLE, PLASTIC (11344-664-12) 1500 ml1992-07-15NoNoCurrent
11344-664-6911344066469250 mL in 1 BOTTLE, PLASTIC (11344-664-69) 250 ml1992-07-15NoNoCurrent
11344-664-7711344066477500 mL in 1 BOTTLE, PLASTIC (11344-664-77) 500 ml1992-07-15NoNoCurrent
11344-664-86113440664861000 mL in 1 BOTTLE, PLASTIC (11344-664-86) 1000 ml1992-07-15NoNoCurrent