Home NDC 0135-0650 Parodontax
Product NDC 0135-0650
11-digit product format 001350650
Labeler code 0135
Product ID 0135-0650_34a4093a-3aa9-3c7b-e063-6294a90a961a
Type HUMAN OTC DRUG
Nonproprietary name cetylpyridinium chloride
Dosage form MOUTHWASH
Route ORAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-03
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .7 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 Parodontax
Brand name suffix Active Gum Health Clear Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .7 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 1100924 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 0135-0650-01 ParodontaxActive Gum Health Clear Mint 500 mL in 1 BOTTLE MOUTHWASH 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0650 PARODONTAX ACTIVE GUM HEALTH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH PARODONTAX ACTIVE GUM HEALTH CLEAR MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [HALEON US HOLDINGS LLC] 5 Current NDC, Legacy NDC, 1 package rows 20250510_444f931d-5e38-4cda-97ba-98aa0b5fe4f6.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 27 of 40 · 786 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 0135-0650-01 00135065001 500 mL in 1 BOTTLE (0135-0650-01) 500 ml 2022-01-03 0000-00-00 No No Current