FDA.reportPublic FDA data

Antiseptic Gel

Product NDC
76598-001
Requested package NDC
76598-001-01
11-digit product format
765980001
Labeler code
76598
Product ID
76598-001_a58fd8fd-27be-f4b0-e053-2995a90af472
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
80 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 packagepackage76598-00176598-001-01IInactivated 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#

NDC, Related label table
NDCRelated label
76598-001-01a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-02a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-03a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-04a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-05a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-06a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-07a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-08a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-09a40f1bf3-83a2-a029-e053-2a95a90a6afa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76598-001-01Antiseptic Gel250 mL in 1 BOTTLEGEL2503
76598-001-02Antiseptic Gel500 mL in 1 BOTTLEGEL5003
76598-001-03Antiseptic Gel1000 mL in 1 BOTTLEGEL10003
76598-001-04Antiseptic Gel5000 mL in 1 BOTTLEGEL50003
76598-001-05Antiseptic Gel20000 mL in 1 PACKAGEGEL200003
76598-001-06Antiseptic Gel200000 mL in 1 DRUMGEL2000003
76598-001-07Antiseptic Gel1000000 mL in 1 TANKGEL10000003
76598-001-08Antiseptic Gel4500 mL in 1 BOTTLEGEL45003
76598-001-09Antiseptic Gel60 mL in 1 BOTTLEGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76598-001ANTISEPTIC GEL (ALCOHOL) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]3Legacy NDC, 9 package rows20200514_a40f1bf3-83a2-a029-e053-2a95a90a6afa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041498ethanol 80 % Topical GelPSNa40f1bf3-83a2-a029-e053-2a95a90a6afa3
1041498ethanol 0.8 ML/ML Topical GelSCDa40f1bf3-83a2-a029-e053-2a95a90a6afa3
1041498ethanol 80 % Topical GelSYa40f1bf3-83a2-a029-e053-2a95a90a6afa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76598-001-0176598000101250 mL in 1 BOTTLE (76598-001-01) 250 ml2020-04-240000-00-00NoNoCurrent