FDA.reportPublic FDA data

Antiseptic Mouth Rinse

Product NDC
55301-072
11-digit product format
553010072
Labeler code
55301
Product ID
55301-072_4aa2c772-8d0a-c645-e063-6394a90a2b7a
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
2002-07-19
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 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 UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9073bc29-434e-4d41-9f22-cf9e57c2f9adAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-072-86Antiseptic Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
sorbitolINACTIVE INGREDIENT506T60A25RANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [YOUR MILITARY EXCHANGE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-072ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [MILITARY EXCHANGES]12Current NDC, Legacy NDC, 1 package rows20250305_9073bc29-434e-4d41-9f22-cf9e57c2f9ad.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLYour Military Exchanges9073bc29-434e-4d41-9f22-cf9e57c2f9ad2026-02-12Warnings, Adverse reactionsExact identifier
ndc (product): 55301-072

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN9073bc29-434e-4d41-9f22-cf9e57c2f9ad13
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD9073bc29-434e-4d41-9f22-cf9e57c2f9ad13
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY9073bc29-434e-4d41-9f22-cf9e57c2f9ad13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-072-86553010072861000 mL in 1 BOTTLE, PLASTIC (55301-072-86) 1000 ml2002-07-190000-00-00NoNoCurrent