Home NDC 31507-544 SENTRY ANTISEPTIC HANDSOAP
Product NDC 31507-544
11-digit product format 315070544
Labeler code 31507
Product ID 31507-544_518cc8b3-6232-b1a2-e063-6394a90a14fd
Type HUMAN OTC DRUG
Nonproprietary name CHLOROXYLENOL
Dosage form SOAP
Route TOPICAL
Labeler Wechem, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-30
Substance CHLOROXYLENOL
Active strength 3 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SENTRY ANTISEPTIC HANDSOAP
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROXYLENOL 3 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 413261 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 31507-544-14 SENTRY ANTISEPTIC HANDSOAP 3785 mL in 1 BOTTLE, PLASTIC SOAP 3785 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31507-544 SENTRY ANTISEPTIC HANDSOAP (CHLOROXYLENOL) SOAP [WECHEM, INC.] 2 Current NDC, 1 package rows 20241204_09041e53-4ca8-9992-e063-6394a90a3062.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 Sample Exclude flag Status 31507-544-14 31507054414 3785 mL in 1 BOTTLE, PLASTIC (31507-544-14) 3785 ml 2023-10-31 No No Current