Wash-Free Surgical Hand Disinfectant Gel II

Product NDC
81630-002
Requested package NDC
81630-002-07
11-digit product format
816300002
Labeler code
81630
Product ID
81630-002_d2d4f43c-4189-47a8-a2ee-eb513a92db88
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol
Dosage form
GEL
Route
TOPICAL
Labeler
Shan Dong Lircon Medical Technology Co., Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-31
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
65 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage81630-00281630-002-07IInactivated by FDA2026-09-14

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81630-002-01Wash-Free Surgical Hand Disinfectant Gel II60 mL in 1 BOTTLE, PLASTICGEL601
81630-002-02Wash-Free Surgical Hand Disinfectant Gel II10 in 1 BOXGEL101
81630-002-03Wash-Free Surgical Hand Disinfectant Gel II10 in 1 BOXGEL101
81630-002-04Wash-Free Surgical Hand Disinfectant Gel II248 mL in 1 BOTTLE, PLASTICGEL2481
81630-002-05Wash-Free Surgical Hand Disinfectant Gel II40 in 1 BOXGEL401
81630-002-06Wash-Free Surgical Hand Disinfectant Gel II500 mL in 1 BOTTLE, PLASTICGEL5001
81630-002-07Wash-Free Surgical Hand Disinfectant Gel II25 in 1 BOXGEL251
81630-002-08Wash-Free Surgical Hand Disinfectant Gel II1000 mL in 1 BOTTLE, PLASTICGEL10001
81630-002-09Wash-Free Surgical Hand Disinfectant Gel II16 in 1 BOXGEL161
81630-002-10Wash-Free Surgical Hand Disinfectant Gel II1000 mL in 1 BOTTLE, PLASTICGEL10001
81630-002-11Wash-Free Surgical Hand Disinfectant Gel II15 in 1 BOXGEL151
81630-002-12Wash-Free Surgical Hand Disinfectant Gel II5000 mL in 1 PACKAGEGEL50001
81630-002-13Wash-Free Surgical Hand Disinfectant Gel II5 in 1 BOXGEL51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81630-002WASH-FREE SURGICAL HAND DISINFECTANT GEL II (ETHANOL) GEL [SHAN DONG LIRCON MEDICAL TECHNOLOGY CO., LTD]1Legacy NDC, 13 package rows20210331_8f17e4a0-831a-4fa2-874a-ad946fa3f0cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2367439ethanol 64.8 % Topical GelPSN8f17e4a0-831a-4fa2-874a-ad946fa3f0cf1
2367439ethanol 0.648 ML/ML Topical GelSCD8f17e4a0-831a-4fa2-874a-ad946fa3f0cf1
2367439ethanol 64.8 % Topical GelSY8f17e4a0-831a-4fa2-874a-ad946fa3f0cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81630-002-078163000020725 BOTTLE, PLASTIC in 1 BOX (81630-002-07) > 500 mL in 1 BOTTLE, PLASTIC (81630-002-06) 2021-03-310000-00-00NoNoCurrent