FDA.reportPublic FDA data

SterileMAX HAND SANITIZER

Product NDC
79325-862
Requested package NDC
79325-862-08
11-digit product format
793250862
Labeler code
79325
Product ID
79325-862_ba579424-6984-4f7c-97dc-a1cebefa37ac
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Pure-chem, Llc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
68 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 packagepackage79325-86279325-862-08IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
79325-862-00STERILEMAX HAND SANITIZER
79325-862-01STERILEMAX HAND SANITIZER
79325-862-02STERILEMAX HAND SANITIZER
79325-862-03STERILEMAX HAND SANITIZER
79325-862-04STERILEMAX HAND SANITIZER
79325-862-08STERILEMAX HAND SANITIZER
79325-862-10STERILEMAX HAND SANITIZER
79325-862-12STERILEMAX HAND SANITIZER
79325-862-15STERILEMAX HAND SANITIZER
79325-862-16STERILEMAX HAND SANITIZER
79325-862-20STERILEMAX HAND SANITIZER
79325-862-25STERILEMAX HAND SANITIZER
79325-862-30STERILEMAX HAND SANITIZER
79325-862-32STERILEMAX HAND SANITIZER
79325-862-64STERILEMAX HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79325-862-00SterileMAX HAND SANITIZER3785 mL in 1 JUGGEL37852
79325-862-01SterileMAX HAND SANITIZER1 mL in 1 POUCHGEL12
79325-862-02SterileMAX HAND SANITIZER59 mL in 1 BOTTLEGEL592
79325-862-03SterileMAX HAND SANITIZER89 mL in 1 BOTTLEGEL892
79325-862-04SterileMAX HAND SANITIZER100 in 1 CONTAINERGEL1002
79325-862-08SterileMAX HAND SANITIZER237 mL in 1 BOTTLEGEL2372
79325-862-10SterileMAX HAND SANITIZER296 mL in 1 BOTTLEGEL2962
79325-862-12SterileMAX HAND SANITIZER355 mL in 1 BOTTLEGEL3552
79325-862-15SterileMAX HAND SANITIZER1.5 mL in 1 POUCHGEL1.52
79325-862-16SterileMAX HAND SANITIZER473 mL in 1 BOTTLEGEL4732
79325-862-20SterileMAX HAND SANITIZER2 mL in 1 POUCHGEL22
79325-862-25SterileMAX HAND SANITIZER2.5 mL in 1 POUCHGEL2.52
79325-862-30SterileMAX HAND SANITIZER3 mL in 1 POUCHGEL32
79325-862-32SterileMAX HAND SANITIZER946 mL in 1 BOTTLEGEL9462
79325-862-64SterileMAX HAND SANITIZER1892 mL in 1 BOTTLEGEL18922

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79325-862STERILEMAX HAND SANITIZER (ALCOHOL) GEL [PURE-CHEM, LLC]2Legacy NDC, 15 package rows20201024_f1bf45b0-3b75-4925-a654-5f2e72cd2c98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037039ethanol 68 % Topical GelPSNf1bf45b0-3b75-4925-a654-5f2e72cd2c982
1037039ethanol 0.68 ML/ML Topical GelSCDf1bf45b0-3b75-4925-a654-5f2e72cd2c982
1037039ethanol 68 % Topical GelSYf1bf45b0-3b75-4925-a654-5f2e72cd2c982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79325-862-0879325086208237 mL in 1 BOTTLE (79325-862-08) 237 ml2020-07-010000-00-00NoNoCurrent