Antiseptic

Product NDC
55301-318
11-digit product format
553010318
Labeler code
55301
Product ID
55301-318_4aa3bae8-f023-1a0c-e063-6294a90a8deb
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Your Military Exchanges
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-07-08
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
Antiseptic
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
55301-318-86Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-318ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [YOUR MILITARY EXCHANGES]13Current NDC, Legacy NDC, 1 package rows20250417_c7350c31-02e4-4fe8-b334-c24a8eb72495.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 % MouthwashPSNc7350c31-02e4-4fe8-b334-c24a8eb7249514
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDc7350c31-02e4-4fe8-b334-c24a8eb7249514
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYc7350c31-02e4-4fe8-b334-c24a8eb7249514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-318-86553010318861000 mL in 1 BOTTLE, PLASTIC (55301-318-86) 1000 ml2002-07-080000-00-00NoNoCurrent