FDA.reportPublic FDA data

Wash-Free Surgical Hand Disinfectant Gel

Product NDC
81630-001
Requested package NDC
81630-001-08
11-digit product format
816300001
Labeler code
81630
Product ID
81630-001_ea824804-fc93-47ae-bc50-706155a8ef91
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
2021-03-12
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
65 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 packagepackage81630-00181630-001-08IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
81630-001-022024-08-07SPL file for drug listing
81630-001-042024-08-07SPL file for drug listing
81630-001-062024-08-07SPL file for drug listing
81630-001-082024-08-07SPL file for drug listing
81630-001-112024-08-07SPL file for drug listing
81630-001-132024-08-07SPL file for drug listing
81630-001-022024-07-30SPL file for drug listing
81630-001-042024-07-30SPL file for drug listing
81630-001-062024-07-30SPL file for drug listing
81630-001-082024-07-30SPL file for drug listing
81630-001-112024-07-30SPL file for drug listing
81630-001-132024-07-30SPL file for drug listing
81630-001-022024-01-30SPL file for drug listing
81630-001-042024-01-30SPL file for drug listing
81630-001-062024-01-30SPL file for drug listing
81630-001-082024-01-30SPL file for drug listing
81630-001-112024-01-30SPL file for drug listing
81630-001-132024-01-30SPL file for drug listing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81630-001-01Wash-Free Surgical Hand Disinfectant GelII60 mL in 1 BOTTLE, PLASTICGEL604
81630-001-02Wash-Free Surgical Hand Disinfectant GelII10 in 1 BOXGEL104
81630-001-03Wash-Free Surgical Hand Disinfectant GelII248 mL in 1 BOTTLE, PLASTICGEL2484
81630-001-04Wash-Free Surgical Hand Disinfectant GelII40 in 1 BOXGEL404
81630-001-05Wash-Free Surgical Hand Disinfectant GelII500 mL in 1 BOTTLE, PLASTICGEL5004
81630-001-06Wash-Free Surgical Hand Disinfectant GelII25 in 1 BOXGEL254
81630-001-07Wash-Free Surgical Hand Disinfectant GelII1000 mL in 1 BOTTLE, PLASTICGEL10004
81630-001-08Wash-Free Surgical Hand Disinfectant GelII16 in 1 BOXGEL164
81630-001-09Wash-Free Surgical Hand Disinfectant GelII10 in 1 BOXGEL104
81630-001-10Wash-Free Surgical Hand Disinfectant GelII1000 mL in 1 BOTTLE, PLASTICGEL10004
81630-001-11Wash-Free Surgical Hand Disinfectant GelII15 in 1 BOXGEL154
81630-001-12Wash-Free Surgical Hand Disinfectant GelII5000 mL in 1 PACKAGEGEL50004
81630-001-13Wash-Free Surgical Hand Disinfectant GelII5 in 1 BOXGEL54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81630-001WASH-FREE SURGICAL HAND DISINFECTANT GEL II (ETHANOL) GEL [SHAN DONG LIRCON MEDICAL TECHNOLOGY CO., LTD]4Legacy NDC, 13 package rows20240809_7eab998d-b6ab-482f-a6ac-e314f8f2a0a5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81630-001-088163000010816 BOTTLE, PLASTIC in 1 BOX (81630-001-08) > 1000 mL in 1 BOTTLE, PLASTIC (81630-001-07) 2021-03-120000-00-00NoNoCurrent