Home NDC 63824-790 Cepacol
Product NDC 63824-790
11-digit product format 638240790
Labeler code 63824
Product ID 63824-790_51b5db79-cd73-82f1-e063-6294a90ad768
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium chloride
Dosage form LIQUID
Route ORAL
Labeler Reckitt Benckiser LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-06-22
Marketing end 2027-09-03
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .05 g/100mL
NDC exclude flag No
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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 63824-790-80 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 63824-790-80 bd6a592717d7…303034d00443…
Additional Listing Data#
Finished product Yes
Brand name base Cepacol
Brand name suffix Antibacterial Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .05 g/100mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1251617 Internal RxNorm lookup 1251619 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63824-790-80 CepacolAntibacterial 710 mL in 1 BOTTLE LIQUID 710 9 63824-790-80 CepacolAntibacterial 1 in 1 CARTON LIQUID 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-790 CEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RB HEALTH (US) LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241220_7c19eba6-3ebd-497f-9066-6152b72eafdd.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 63824-790-80 63824079080 1 BOTTLE in 1 CARTON (63824-790-80) / 710 mL in 1 BOTTLE 1 bottle 2011-06-22 2027-09-03 No No Current