Wash-Free Surgical Hand Disinfectant Gel II

Product NDC
81630-003
Requested package NDC
81630-003-13
11-digit product format
816300003
Labeler code
81630
Product ID
81630-003_178ff765-af2b-4025-8fca-61190f4bfec6
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
75 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 packagepackage81630-00381630-003-13IInactivated 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81630-003-01Wash-Free Surgical Hand Disinfectant Gel II60 mL in 1 BOTTLE, PLASTICGEL605
81630-003-02Wash-Free Surgical Hand Disinfectant Gel II10 in 1 BOXGEL105
81630-003-03Wash-Free Surgical Hand Disinfectant Gel II10 in 1 BOXGEL105
81630-003-04Wash-Free Surgical Hand Disinfectant Gel II248 mL in 1 BOTTLE, PLASTICGEL2485
81630-003-05Wash-Free Surgical Hand Disinfectant Gel II40 in 1 BOXGEL405
81630-003-06Wash-Free Surgical Hand Disinfectant Gel II500 mL in 1 BOTTLE, PLASTICGEL5005
81630-003-07Wash-Free Surgical Hand Disinfectant Gel II25 in 1 BOXGEL255
81630-003-08Wash-Free Surgical Hand Disinfectant Gel II1000 mL in 1 BOTTLE, PLASTICGEL10005
81630-003-09Wash-Free Surgical Hand Disinfectant Gel II16 in 1 BOXGEL165
81630-003-10Wash-Free Surgical Hand Disinfectant Gel II1000 mL in 1 BOTTLE, PLASTICGEL10005
81630-003-11Wash-Free Surgical Hand Disinfectant Gel II15 in 1 BOXGEL155
81630-003-12Wash-Free Surgical Hand Disinfectant Gel II5000 mL in 1 PACKAGEGEL50005
81630-003-13Wash-Free Surgical Hand Disinfectant Gel II5 in 1 BOXGEL55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81630-003WASH-FREE SURGICAL HAND DISINFECTANT GEL II (ETHANOL) GEL [SHAN DONG LIRCON MEDICAL TECHNOLOGY CO., LTD]5Legacy NDC, 13 package rows20240809_a33e3f0c-9ab7-4181-b4ed-568f28a9c722.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa33e3f0c-9ab7-4181-b4ed-568f28a9c7225
1305100ethanol 0.75 ML/ML Topical GelSCDa33e3f0c-9ab7-4181-b4ed-568f28a9c7225
1305100ethanol 75 % Topical GelSYa33e3f0c-9ab7-4181-b4ed-568f28a9c7225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81630-003-13816300003135 PACKAGE in 1 BOX (81630-003-13) > 5000 mL in 1 PACKAGE (81630-003-12) 5 package2021-03-310000-00-00NoNoCurrent