Home NDC 0404-4438-01 Antibacterial Hand
Product NDC 0404-4438
Requested package NDC 0404-4438-01
11-digit product format 004044438
Labeler code 0404
Product ID 0404-4438_2b5c0641-524c-f65e-e063-6294a90a1f72
Type HUMAN OTC DRUG
Nonproprietary name chloroxylenol
Dosage form SOAP
Route TOPICAL
Labeler Henry Schein, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-01-30
Substance CHLOROXYLENOL
Active strength 6.1 g/L
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 · 1 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 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0404-4438 0404-4438-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Antibacterial Hand
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROXYLENOL 6.1 g/L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0F32U78V2Q Internal UNII 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 0404-4438-01 Antibacterial Hand 0.473 L in 1 BOTTLE SOAP 0.473 5 0404-4438-02 Antibacterial Hand 0.237 L in 1 BOTTLE SOAP 0.237 5 0404-4438-03 Antibacterial Hand 3.785 L in 1 BOTTLE SOAP 3.785 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded chloroxylenol ACTIVE INGREDIENT 0F32U78V2Q ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 chloroxylenol ACTIVE MOIETY 0F32U78V2Q ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 .alpha.-tocopherol acetate INACTIVE INGREDIENT 9E8X80D2L0 ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 cocamidopropyl betaine INACTIVE INGREDIENT 5OCF3O11KX ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 coco diethanolamide INACTIVE INGREDIENT 92005F972D ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 diazolidinyl urea INACTIVE INGREDIENT H5RIZ3MPW4 ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 edetate sodium INACTIVE INGREDIENT MP1J8420LU ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 sodium laureth-3 sulfate INACTIVE INGREDIENT BPV390UAP0 ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-4438 ANTIBACTERIAL HAND (CHLOROXYLENOL) SOAP [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 3 package rows 20250112_b108cec8-c2f8-4fcf-b317-90c51469da45.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-4438-01 00404443801 .473 L in 1 BOTTLE (0404-4438-01) 2013-01-30 0000-00-00 No No Current