Antiseptic

Product NDC
0869-0072
Requested package NDC
0869-0072-86
11-digit product format
008690072
Labeler code
0869
Product ID
0869-0072_4cd533bc-4a49-32f6-e063-6394a90a1a15
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Vi Jon, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1988-07-20
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0869-00720869-0072-86DDiscontinued by firm2026-08-03

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 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
70ee47e6-49cb-4ede-869d-cbad61ddcedcAvailable 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
0869-0072-12Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150023
0869-0072-13Antiseptic1250 mL in 1 BOTTLE, PLASTICMOUTHWASH125023
0869-0072-19Antiseptic94 mL in 1 BOTTLE, PLASTICMOUTHWASH9423
0869-0072-21Antiseptic89 mL in 1 BOTTLE, PLASTICMOUTHWASH8923
0869-0072-50Antiseptic710 mL in 1 BOTTLE, PLASTICMOUTHWASH71023
0869-0072-69Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25023
0869-0072-77Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50023
0869-0072-86Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100023
0869-0072-88Antiseptic2000 mL in 1 BOTTLE, PLASTICMOUTHWASH200023

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0869-0072ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI JON, LLC]21Current NDC, Legacy NDC, 9 package rows20250322_70ee47e6-49cb-4ede-869d-cbad61ddcedc.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
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLVi Jon, LLC70ee47e6-49cb-4ede-869d-cbad61ddcedc2026-03-12Warnings, Adverse reactionsExact identifier
ndc (package): 0869-0072-86
ndc (product): 0869-0072
ndc11 (package): 00869007286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN70ee47e6-49cb-4ede-869d-cbad61ddcedc23
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD70ee47e6-49cb-4ede-869d-cbad61ddcedc23
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY70ee47e6-49cb-4ede-869d-cbad61ddcedc23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0869-0072-86008690072861000 mL in 1 BOTTLE, PLASTIC (0869-0072-86) 1000 ml1988-07-200000-00-00NoNoCurrent