Home NDC 36800-299 Antiseptic
Product NDC 36800-299
11-digit product format 368000299
Labeler code 36800
Product ID 36800-299_4ab84f55-b795-e80b-e063-6394a90a927a
Type HUMAN OTC DRUG
Nonproprietary name CETYLPYRIDINIUM CHLORIDE
Dosage form RINSE
Route ORAL
Labeler Topco Associates LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 1993-08-03
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .7 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 36800-299 36800-299-21 D Discontinued by firm 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antiseptic CETYLPYRIDINIUM CHLORIDE Topco Associates LLC 857e8bc4-125f-4796-ac10-6880702816fe 2026-02-13 Warnings, Adverse reactions Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings for this product Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control center right away.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTION DISTRIBUTED BY TOPCO ASSOCIATES, LLC, ITASCA, IL 60143 ©TOPCO VIJA0125 QUESTIONS? 1-888-423-0139 topcare@topcare.com www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED
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 Identifiers# Field, Values table Field Values Unii D9OM4SK49P Rxcui 1100924
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-299-21 Antiseptic 89 mL in 1 BOTTLE, PLASTIC RINSE 89 15 36800-299-86 Antiseptic 1000 mL in 1 BOTTLE, PLASTIC RINSE 1000 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-299 ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [TOPCO ASSOCIATES LLC] 14 Current NDC, Legacy NDC, 2 package rows 20250529_857e8bc4-125f-4796-ac10-6880702816fe.zip
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 36800-299-21 36800029921 89 mL in 1 BOTTLE, PLASTIC (36800-299-21) 89 ml 1993-08-03 0000-00-00 No No Current 36800-299-86 36800029986 1000 mL in 1 BOTTLE, PLASTIC (36800-299-86) 1000 ml 1993-08-03 0000-00-00 No No Current