Home NDC 69892-072-77 Antiseptic Mouthrinse
Product NDC 69892-072
Requested package NDC 69892-072-77
11-digit product format 698920072
Labeler code 69892
Product ID 69892-072_5241ec53-82cc-1d4c-e063-6294a90a39e3
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Rockland Cosmetics, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-15
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 Antiseptic Mouthrinse
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 69892-072-77 Antiseptic Mouthrinse 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 4 69892-072-86 Antiseptic Mouthrinse 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69892-072 ANTISEPTIC MOUTHRINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [ROCKLAND COSMETICS, INC.] 2 Current NDC, 2 package rows 20250515_b7c63ae5-08a8-436a-bbaa-f3ab3c2a5e67.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 69892-072-77 69892007277 500 mL in 1 BOTTLE, PLASTIC (69892-072-77) 500 ml 2024-05-15 No No Current