Antispetic

Product NDC
15127-318
Requested package NDC
15127-318-69
11-digit product format
151270318
Labeler code
15127
Product ID
15127-318_7c904ed4-1784-4347-9719-14c072c6528b
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Select Brand Distributors
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1991-12-09
Marketing end
0000-00-00
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage15127-31815127-318-69DDiscontinued by firm2026-10-05

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
THYMOLACTIVE MOIETY3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SELECT BRAND DISTRIBUTORS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15127-318-6915127031869250 mL in 1 BOTTLE, PLASTIC (15127-318-69) 250 ml1991-12-090000-00-00NoNoCurrent