Home NDC 23590-300 Summit E2
Product NDC 23590-300
11-digit product format 235900300
Labeler code 23590
Product ID 23590-300_4d66824a-b004-e0c5-e063-6394a90a82f5
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SOAP
Route TOPICAL
Labeler R.L. Williams Company
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-20
Substance BENZALKONIUM CHLORIDE
Active strength 1 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 23590-300-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 23590-300-10 f5e01cc5f278…a2eaf40c39c3…
Additional Listing Data#
Finished product Yes
Brand name base Summit E2
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1 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 1233282 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 23590-300-10 Summit E2 850 mL in 1 BOTTLE, PUMP SOAP 850 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23590-300 SUMMIT E2 (BENZALKONIUM CHLORIDE) SOAP [R. L. WILLIAMS COMPANY] 4 Current NDC, Legacy NDC, 1 package rows 20231223_dec25905-5b08-4866-a2a5-4c60409761fc.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 23590-300-10 23590030010 850 mL in 1 BOTTLE, PUMP (23590-300-10) 850 ml 2026-03-20 0000-00-00 No No Current