Home NDC 77238-231-41 Hand Sanitizer
Product NDC 77238-231
Requested package NDC 77238-231-41
11-digit product format 772380231
Labeler code 77238
Product ID 77238-231_463d3fcf-70c1-f717-e063-6394a90a3612
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE
Dosage form GEL
Route TOPICAL
Labeler DGH Pharma, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-01
Substance BENZALKONIUM CHLORIDE
Active strength .1 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hand Sanitizer
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .1 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 1049228 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 77238-231-11 Hand Sanitizer 30 mL in 1 BOTTLE, SPRAY GEL 30 4 77238-231-14 Hand Sanitizer 118 mL in 1 BOTTLE GEL 118 4 77238-231-24 Hand Sanitizer 118 mL in 1 BOTTLE GEL 118 4 77238-231-31 Hand Sanitizer 30 mL in 1 BOTTLE, SPRAY GEL 30 4 77238-231-41 Hand Sanitizer 30 mL in 1 BOTTLE, SPRAY GEL 30 4 77238-231-44 Hand Sanitizer 118 mL in 1 BOTTLE GEL 118 4 77238-231-48 Hand Sanitizer 3785 mL in 1 JUG GEL 3785 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77238-231 HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [DGH PHARMA, INC.] 4 Current NDC, Legacy NDC, 7 package rows 20220731_ae4311f8-fc40-38a7-e053-2a95a90ae829.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 9 of 115 · 2,286 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 77238-231-41 77238023141 30 mL in 1 BOTTLE, SPRAY (77238-231-41) 30 ml 2022-07-01 0000-00-00 No No Current