Home NDC 62819-268 Total Solutions Hygien Hand
Product NDC 62819-268
11-digit product format 628190268
Labeler code 62819
Product ID 62819-268_2a8551bf-9018-2a4d-e063-6294a90a15e7
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium
Dosage form SOAP
Route TOPICAL
Labeler Athea Laboratories, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-01-18
Substance BENZALKONIUM CHLORIDE
Active strength .12 g/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 · 3 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 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 62819-268 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 62819-268 62819-268-02 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 62819-268 62819-268-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base Total Solutions Hygien Hand
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .12 g/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 1053188 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 62819-268-01 Total Solutions Hygien Hand 3785 mL in 1 BOTTLE, PLASTIC SOAP 3785 4 62819-268-02 Total Solutions Hygien Hand 473 mL in 1 BOTTLE, PLASTIC SOAP 473 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62819-268 TOTAL SOLUTIONS HYGIEN HAND (BENZALKONIUM) SOAP [ATHEA LABORATORIES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250101_fcd63fe4-a357-4432-a738-ae1bccbb8bae.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 62819-268-01 62819026801 3785 mL in 1 BOTTLE, PLASTIC (62819-268-01) 3785 ml 2013-01-18 0000-00-00 No No Current 62819-268-02 62819026802 473 mL in 1 BOTTLE, PLASTIC (62819-268-02) 473 ml 2013-01-18 0000-00-00 No No Current