Home NDC 84239-000-00 Equate Healthy Gums Clean Mint Breath Oral Rinse
Product NDC 84239-000
Requested package NDC 84239-000-00
11-digit product format 842390000
Labeler code 84239
Product ID 84239-000_2901a1df-7cd4-7cf2-e063-6394a90a8c91
Type HUMAN OTC DRUG
Nonproprietary name CETYLPYRIDINIUM CHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Vasu Healthcare Pvt. Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-25
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Equate Healthy Gums Clean Mint Breath Oral Rinse
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D9OM4SK49P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251617 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 84239-000-00 Equate Healthy Gums Clean Mint Breath Oral Rinse 475 mL in 1 BOTTLE LIQUID 475 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84239-000 EQUATE HEALTHY GUMS CLEAN MINT BREATH ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) LIQUID [VASU HEALTHCARE PVT. LTD.] 3 Current NDC, 1 package rows 20250125_05fc922a-73fc-4826-be77-538da08282b9.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 84239-000-00 84239000000 475 mL in 1 BOTTLE (84239-000-00) 475 ml 2025-01-25 No No Current