Home NDC 68016-318-77 Antiseptic Mouth Rinse
Product NDC 68016-318
Requested package NDC 68016-318-77
11-digit product format 680160318
Labeler code 68016
Product ID 68016-318_4a19e4b0-ff49-e257-e063-6294a90afa45
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Pharmacy Value Alliance, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2003-08-19
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68016-318 68016-318-77 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68016-318 68016-318-77 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-318-77 Antiseptic Mouth Rinse 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 16 68016-318-86 Antiseptic Mouth Rinse 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EUCALYPTOL ACTIVE INGREDIENT RV6J6604TK ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 THYMOL ACTIVE INGREDIENT 3J50XA376E ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 EUCALYPTOL ACTIVE MOIETY RV6J6604TK ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 METHYL SALICYLATE ACTIVE MOIETY LAV5U5022Y ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 THYMOL ACTIVE MOIETY 3J50XA376E ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 CARAMEL INACTIVE INGREDIENT T9D99G2B1R ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CHAIN DRUG CONSORTIUM, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-318 ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PHARMACY VALUE ALLIANCE, LLC] 15 Current NDC, Legacy NDC, 2 package rows 20250423_d7c047b6-de1f-4e7e-8e4d-6fd80c8f8d2f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-318-77 68016031877 500 mL in 1 BOTTLE, PLASTIC (68016-318-77) 500 ml 2003-08-19 0000-00-00 No No Current