Antiseptic Gel Hand Sanitizer

Product NDC
76598-004
Requested package NDC
76598-004-08
11-digit product format
765980004
Labeler code
76598
Product ID
76598-004_ae6ae49e-97c8-9ba1-e053-2a95a90ac170
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
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
ALCOHOL
Active strength
70 mL/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 packagepackage76598-00476598-004-08IInactivated by FDA2026-10-12

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
76598-004-01Antiseptic Gel Hand Sanitizer70 v/v200 mL in 1 BOTTLEGEL2002
76598-004-02Antiseptic Gel Hand Sanitizer70 v/v60 mL in 1 BOTTLEGEL602
76598-004-03Antiseptic Gel Hand Sanitizer70 v/v250 mL in 1 BOTTLEGEL2502
76598-004-04Antiseptic Gel Hand Sanitizer70 v/v500 mL in 1 BOTTLEGEL5002
76598-004-05Antiseptic Gel Hand Sanitizer70 v/v1000 mL in 1 PACKAGEGEL10002
76598-004-06Antiseptic Gel Hand Sanitizer70 v/v3785 mL in 1 DRUMGEL37852
76598-004-07Antiseptic Gel Hand Sanitizer70 v/v1000000 mL in 1 TANKGEL10000002
76598-004-08Antiseptic Gel Hand Sanitizer70 v/v20000 mL in 1 DRUMGEL200002
76598-004-09Antiseptic Gel Hand Sanitizer70 v/v200000 mL in 1 TANKGEL2000002
76598-004-10Antiseptic Gel Hand Sanitizer70 v/v4 mL in 1 POUCHGEL42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76598-004ANTISEPTIC GEL HAND SANITIZER 70 V/V (ALCOHOL) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]2Legacy NDC, 10 package rows20200904_a873f92e-561a-f1e8-e053-2995a90ad2f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa873f92e-561a-f1e8-e053-2995a90ad2f32
581662ethanol 0.7 ML/ML Topical GelSCDa873f92e-561a-f1e8-e053-2995a90ad2f32
581662ethanol 70 % Topical GelSYa873f92e-561a-f1e8-e053-2995a90ad2f32
581662ethyl alcohol 70 % Topical GelSYa873f92e-561a-f1e8-e053-2995a90ad2f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76598-004-087659800040820000 mL in 1 DRUM (76598-004-08) 20000 ml2020-04-240000-00-00NoNoCurrent