Home NDC 11344-299 Antiseptic
Product NDC 11344-299
11-digit product format 113440299
Labeler code 11344
Product ID 11344-299_4cea05a3-8aea-57c5-e063-6394a90a7235
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form RINSE
Route ORAL
Labeler Nice-Pak Products, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-29
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .7 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Antiseptic
Listing expiration 2027-12-31 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 11344-299-77 Antiseptic 500 mL in 1 BOTTLE, PLASTIC RINSE 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-299 ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [CONSUMER PRODUCT PARTNERS, LLC] 3 Current NDC, 1 package rows 20250515_98c0dadd-c8f9-4955-bd0d-70b14dcf00c2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antiseptic CETYLPYRIDINIUM CHLORIDE Nice-Pak Products, LLC 98c0dadd-c8f9-4955-bd0d-70b14dcf00c2 2026-08-10 Warnings, Adverse reactions Exact identifier ndc (product): 11344-299
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11344-299-77 11344029977 500 mL in 1 BOTTLE, PLASTIC (11344-299-77) 500 ml 2024-04-29 No No Current