Home NDC 69892-664-86 Antispetic
Product NDC 69892-664
Requested package NDC 69892-664-86
11-digit product format 698920664
Labeler code 69892
Product ID 69892-664_5241bf71-869f-3bdc-e063-6394a90a6da9
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 Antispetic
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 69892-664-19 Antispetic 94 mL in 1 BOTTLE, PLASTIC MOUTHWASH 94 4 69892-664-77 Antispetic 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 4 69892-664-86 Antispetic 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 69892-664 ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [ROCKLAND COSMETICS, INC.] 2 Current NDC, 3 package rows 20250515_1bbae739-5e54-64cb-e063-6294a90a3745.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 69892-664-86 69892066486 1000 mL in 1 BOTTLE, PLASTIC (69892-664-86) 1000 ml 2026-05-20 No No Current