Antiseptic

Product NDC
0869-0072
Requested package NDC
0869-0072-21
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 packagepackage0869-00720869-0072-21DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

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
0869-0072-210086900722189 mL in 1 BOTTLE, PLASTIC (0869-0072-21) 89 ml1988-07-200000-00-00NoNoCurrent