Home NDC 76162-855-12 Tartar control plus Antiseptic
Product NDC 76162-855
Requested package NDC 76162-855-12
11-digit product format 761620855
Labeler code 76162
Product ID 76162-855_4abb7e79-a169-92ea-e063-6394a90a8a99
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Topco Associates LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-06
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tartar control plus Antiseptic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EUCALYPTOL .92 mg/mL MENTHOL .42 mg/mL METHYL SALICYLATE .6 mg/mL THYMOL .64 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043619 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-855-12 Tartar control plus Antiseptic 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-855 TARTAR CONTROL PLUS ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [TOPCO ASSOCIATES LLC] 2 Current NDC, 1 package rows 20250509_0d97cb54-1b9c-4aff-a15c-3bf9b6678209.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76162-855-12 76162085512 1500 mL in 1 BOTTLE, PLASTIC (76162-855-12) 1500 ml 2024-05-06 No No Current