Antispetic

Product NDC
0869-0664
11-digit product format
008690664
Labeler code
0869
Product ID
0869-0664_4cd574f9-828e-7abe-e063-6394a90a8835
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
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

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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0869-0664DDiscontinued by firm2026-08-17
excluded packagepackage0869-06640869-0664-12DDiscontinued by firm2026-08-17
excluded packagepackage0869-06640869-0664-13DDiscontinued by firm2026-08-17
excluded packagepackage0869-06640869-0664-19DDiscontinued by firm2026-08-17
excluded packagepackage0869-06640869-0664-69DDiscontinued by firm2026-08-17
excluded packagepackage0869-06640869-0664-77DDiscontinued by firm2026-08-17
excluded packagepackage0869-06640869-0664-86DDiscontinued by firm2026-08-17
excluded packagepackage0869-06640869-0664-88DDiscontinued 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 · 40 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050869-0664-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050869-0664-86d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050869-0664-69d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050869-0664-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050869-0664-19d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260869-0664-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260869-0664-86f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260869-0664-69f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260869-0664-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260869-0664-19f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310869-0664-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310869-0664-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310869-0664-192ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280869-0664-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280869-0664-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280869-0664-19a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210869-0664-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210869-0664-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210869-0664-19cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100869-0664-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100869-0664-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100869-0664-19cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310869-0664-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310869-0664-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310869-0664-19302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200869-0664-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200869-0664-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200869-0664-19ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100869-0664-880efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100869-0664-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100869-0664-190efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080869-0664-88ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080869-0664-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080869-0664-19ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030869-0664-88367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030869-0664-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030869-0664-19367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090869-0664-88557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090869-0664-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090869-0664-19557ba5c1ecfa…9c80585c8c6e…

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
0869-0664-12Antispetic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150017
0869-0664-13Antispetic1250 mL in 1 BOTTLE, PLASTICMOUTHWASH125017
0869-0664-19Antispetic94 mL in 1 BOTTLE, PLASTICMOUTHWASH9417
0869-0664-69Antispetic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25017
0869-0664-77Antispetic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50017
0869-0664-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100017
0869-0664-88Antispetic2000 mL in 1 BOTTLE, PLASTICMOUTHWASH200017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
THYMOLACTIVE MOIETY3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0869-0664ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON, LLC]16Current NDC, Legacy NDC, 7 package rows20250514_8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1.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 % MouthwashPSN8bdbfc38-7c14-4162-8d5f-c0bbb7765ea117
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD8bdbfc38-7c14-4162-8d5f-c0bbb7765ea117
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY8bdbfc38-7c14-4162-8d5f-c0bbb7765ea117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0869-0664-12008690664121500 mL in 1 BOTTLE, PLASTIC (0869-0664-12) 1500 ml1992-07-150000-00-00NoNoCurrent
0869-0664-13008690664131250 mL in 1 BOTTLE, PLASTIC (0869-0664-13) 1250 ml1992-07-150000-00-00NoNoCurrent
0869-0664-190086906641994 mL in 1 BOTTLE, PLASTIC (0869-0664-19) 94 ml1992-07-150000-00-00NoNoCurrent
0869-0664-6900869066469250 mL in 1 BOTTLE, PLASTIC (0869-0664-69) 250 ml1992-07-150000-00-00NoNoCurrent
0869-0664-7700869066477500 mL in 1 BOTTLE, PLASTIC (0869-0664-77) 500 ml1992-07-150000-00-00NoNoCurrent
0869-0664-86008690664861000 mL in 1 BOTTLE, PLASTIC (0869-0664-86) 1000 ml1992-07-150000-00-00NoNoCurrent
0869-0664-88008690664882000 mL in 1 BOTTLE, PLASTIC (0869-0664-88) 2000 ml1992-07-150000-00-00NoNoCurrent