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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-299 36800-299-21 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 36800-299 36800-299-21 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 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
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 Topco Associates LLC 857e8bc4-125f-4796-ac10-6880702816fe 2026-02-13 Warnings, Adverse reactions Exact identifier ndc (product): 36800-299
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