Anitseptic Mouth Rinse

Product NDC
68016-941
11-digit product format
680160941
Labeler code
68016
Product ID
68016-941_b1e80dce-33d8-4538-a1a3-dbb411b66fad
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Pharmacy Value Alliance LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2003-08-19
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-941DDiscontinued by firm2026-10-15
excluded packagepackage68016-94168016-941-77DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-941ANITSEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PHARMACY VALUE ALLIANCE LLC]19Legacy NDC20250312_6d611caa-b382-48f9-b954-8ea5cf198aa2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-941-77680160941771000 mL in 1 BOTTLE, PLASTIC (68016-941-77) 1000 ml2003-08-190000-00-00NoNoCurrent