Antispetic

Product NDC
68016-664
Requested package NDC
68016-664-86
11-digit product format
680160664
Labeler code
68016
Product ID
68016-664_6849391e-ed6e-4804-83be-df39fed284d5
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Pharmacy Value Alliance LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-05-15
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 packagepackage68016-66468016-664-86DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-664ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PHARMACY VALUE ALLIANCE LLC]14Legacy NDC20250507_9e83e4eb-4a74-4646-812e-1d208043e2c4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-664-86680160664861000 mL in 1 BOTTLE, PLASTIC (68016-664-86) 1000 ml2009-05-150000-00-00NoNoCurrent