Hand Sanitizer Gel

Product NDC
68210-4075
Requested package NDC
68210-4075-5
11-digit product format
682104075
Labeler code
68210
Product ID
68210-4075_ef1ab0fb-c126-2c31-e053-2995a90a7187
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-08
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68210-407568210-4075-5IInactivated 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4075-1Hand Sanitizer Gel150 mL in 1 BOTTLEGEL1507
68210-4075-2Hand Sanitizer Gel250 mL in 1 BOTTLEGEL2507
68210-4075-3Hand Sanitizer Gel75 mL in 1 BOTTLEGEL757
68210-4075-4Hand Sanitizer Gel4000 mL in 1 BOTTLEGEL40007
68210-4075-5Hand Sanitizer Gel500 mL in 1 BOTTLEGEL5007
68210-4075-6Hand Sanitizer Gel65 mL in 1 BOTTLEGEL657
68210-4075-7Hand Sanitizer Gel2000 mL in 1 PACKAGEGEL20007
68210-4075-8Hand Sanitizer Gel1000 mL in 1 PACKAGEGEL10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4075HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 8 package rows20221206_2ae0fdcd-fa1c-4a3e-95be-834710ea182c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN2ae0fdcd-fa1c-4a3e-95be-834710ea182c7
581662ethanol 0.7 ML/ML Topical GelSCD2ae0fdcd-fa1c-4a3e-95be-834710ea182c7
581662ethanol 70 % Topical GelSY2ae0fdcd-fa1c-4a3e-95be-834710ea182c7
581662ethyl alcohol 70 % Topical GelSY2ae0fdcd-fa1c-4a3e-95be-834710ea182c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4075-568210407505500 mL in 1 BOTTLE (68210-4075-5) 500 ml2020-06-080000-00-00NoNoCurrent