Home NDC 50804-299-86 Antiseptic
Product NDC 50804-299
Requested package NDC 50804-299-86
11-digit product format 508040299
Labeler code 50804
Product ID 50804-299_4b3109c5-ee75-3105-e063-6394a90af028
Type HUMAN OTC DRUG
Nonproprietary name CETYLPYRIDINIUM CHLORIDE
Dosage form RINSE
Route ORAL
Labeler Perrigo Direct, Inc
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 1993-09-20
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…
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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50804-299-86 Antiseptic 1000 mL in 1 BOTTLE, PLASTIC RINSE 1000 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50804-299 ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [PERRIGO DIRECT, INC] 16 Current NDC, Legacy NDC, 1 package rows 20240920_4d452c85-8e28-4915-a638-c71fc9cc77d6.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 Marketing end Sample Exclude flag Status 50804-299-86 50804029986 1000 mL in 1 BOTTLE, PLASTIC (50804-299-86) 1000 ml 1993-09-20 0000-00-00 No No Current