Home NDC 44577-711 TRI-SOFT SOFTENING
Product NDC 44577-711
11-digit product format 445770711
Labeler code 44577
Product ID 44577-711_0973c7d8-bd6d-e83b-e063-6294a90acf55
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE
Dosage form SOLUTION
Route TOPICAL
Labeler Clinical Therapeutic Solutions
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-12-06
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TRI-SOFT SOFTENING
Listing expiration 2026-12-31 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 1046593 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 44577-711-08 TRI-SOFT SOFTENING 236.59 mL in 1 BOTTLE SOLUTION 236.59 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44577-711 TRI-SOFT SOFTENING (BENZALKONIUM CHLORIDE) SOLUTION [CLINICAL THERAPEUTIC SOLUTIONS] 4 Current NDC, Legacy NDC, 1 package rows 20231106_3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb.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 44577-711-08 44577071108 236.59 mL in 1 BOTTLE (44577-711-08) 236.59 ml 2017-02-22 0000-00-00 No No Current