Alcohol-Free Antiseptic Gel

Product NDC
76598-010
Requested package NDC
76598-010-03
11-digit product format
765980010
Labeler code
76598
Product ID
76598-010_adc00888-033b-d9a1-e053-2995a90a7d97
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Bioagaves de la Costa, S.A. de C.V.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-24
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
13 mg/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76598-01076598-010-03IInactivated by FDA2026-10-05

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76598-010-01Alcohol-Free Antiseptic Gel4 mL in 1 POUCHGEL41
76598-010-02Alcohol-Free Antiseptic Gel60 mL in 1 BOTTLEGEL601
76598-010-03Alcohol-Free Antiseptic Gel250 mL in 1 BOTTLEGEL2501
76598-010-04Alcohol-Free Antiseptic Gel500 mL in 1 BOTTLEGEL5001
76598-010-05Alcohol-Free Antiseptic Gel1000 mL in 1 BOTTLEGEL10001
76598-010-06Alcohol-Free Antiseptic Gel3780 mL in 1 BOTTLEGEL37801
76598-010-07Alcohol-Free Antiseptic Gel4500 mL in 1 BOTTLEGEL45001
76598-010-08Alcohol-Free Antiseptic Gel20000 mL in 1 JUGGEL200001
76598-010-09Alcohol-Free Antiseptic Gel200000 mL in 1 JUGGEL2000001
76598-010-10Alcohol-Free Antiseptic Gel1000000 mL in 1 JUGGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76598-010ALCOHOL-FREE ANTISEPTIC GEL (BENZALKONIUM CHLORIDE) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]1Legacy NDC, 10 package rows20200827_adc00888-033c-d9a1-e053-2995a90a7d97.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76598-010-0376598001003250 mL in 1 BOTTLE (76598-010-03) 250 ml2020-04-240000-00-00NoNoCurrent