Home NDC 48404-050-01 pre fense unscented
Product NDC 48404-050
Requested package NDC 48404-050-01
11-digit product format 484040050
Labeler code 48404
Product ID 48404-050_4428ab74-189c-d384-e063-6294a90ad56b
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Prefense LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-15
Substance BENZALKONIUM CHLORIDE
Active strength 120 mg/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 48404-050 48404-050-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 48404-050 48404-050-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base pre fense unscented
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 120 mg/100mL
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 1052949 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 48404-050-01 pre fense unscented 44.4 mL in 1 BOTTLE LIQUID 44.4 7 48404-050-02 pre fense unscented 236.6 mL in 1 BOTTLE LIQUID 236.6 7 48404-050-03 pre fense unscented 502.8 mL in 1 BOTTLE LIQUID 502.8 7 48404-050-04 pre fense unscented 236.6 mL in 1 BOTTLE LIQUID 236.6 7 48404-050-04 pre fense unscented 3 in 1 PACKAGE LIQUID 3 7 48404-050-05 pre fense unscented 6 in 1 PACKAGE LIQUID 6 7 48404-050-05 pre fense unscented 44.4 mL in 1 BOTTLE LIQUID 44.4 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48404-050 PRE FENSE UNSCENTED (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC] 4 Current NDC, Legacy NDC, 7 package rows 20250122_a59e9bbf-b60e-970a-e053-2a95a90aaa5e.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 48404-050-01 48404005001 44.4 mL in 1 BOTTLE (48404-050-01) 44.4 ml 2020-05-15 0000-00-00 No No Current