Home NDC 53942-072-13 Antiseptic Mouth Rinse
Product NDC 53942-072
Requested package NDC 53942-072-13
11-digit product format 539420072
Labeler code 53942
Product ID 53942-072_5c8c7613-a2cb-f06d-e063-6294a90a1048
Type HUMAN OTC DRUG
Nonproprietary name EUCALYPTOL, Menthol, Methyl salicylate, thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Demoulas Super Markets, Inc
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-03-30
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
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 Antiseptic Mouth Rinse
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53942-072-12 Antiseptic Mouth Rinse 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 19 53942-072-13 Antiseptic Mouth Rinse 1250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1250 19 53942-072-77 Antiseptic Mouth Rinse 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 19 53942-072-86 Antiseptic Mouth Rinse 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53942-072 ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS] 18 Current NDC, Legacy NDC, 4 package rows 20250309_87263c47-0977-487f-a348-8b9e2ee69446.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 Marketing end Sample Exclude flag Status 53942-072-13 53942007213 1250 mL in 1 BOTTLE, PLASTIC (53942-072-13) 1250 ml 2007-03-30 0000-00-00 No No Current