Home NDC 50980-207 Ben E. Keith FIHS
Product NDC 50980-207
11-digit product format 509800207
Labeler code 50980
Product ID 50980-207_09c78743-cb8d-483c-a5f5-781cc220c0e2
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SOLUTION
Route TOPICAL
Labeler Ben E. Keith Foods
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-05-31
Marketing end 2026-11-18
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
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 50980-207-31 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 50980-207-31 bd6a592717d7…303034d00443…
Additional Listing Data#
Finished product Yes
Brand name base Ben E. Keith FIHS Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020365 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 50980-207-12 Ben E. Keith FIHS 1000 mL in 1 BAG SOLUTION 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50980-207 BEN E. KEITH FIHS (BENZALKONIUM CHLORIDE) SOLUTION [BEN E. KEITH FOODS] 5 Current NDC, Legacy NDC, 1 package rows 20250305_4ca21370-1ecf-42c6-9c32-79cf994c336b.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 50980-207-12 50980020712 1000 mL in 1 BAG (50980-207-12) 1000 ml 2016-05-31 2026-11-18 No No Current 50980-207-31 50980020731 1000 mL in 1 BAG (50980-207-31) 1000 ml 2016-05-31 0000-00-00 No No Current