FDA.reportPublic FDA data

Color Element Hand Sanitizer with Moisturizers and Vitamin E

Product NDC
74934-001
Requested package NDC
74934-001-61
11-digit product format
749340001
Labeler code
74934
Product ID
74934-001_acb0ffb4-b351-4ce1-e053-2995a90a4cb1
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Zhejiang iColor Biotech Co., Ltd
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-14
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
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 packagepackage74934-00174934-001-61DDiscontinued by firm2026-10-12

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74934-001COLOR ELEMENT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [ZHEJIANG ICOLOR BIOTECH CO., LTD]10Legacy NDC20240113_f9c68145-224e-4c1d-b574-dc466c56217f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307051ethanol 75 % Medicated PadPSN0f0c79cb-88bf-4db4-b759-4c2ca81f2d591
1305100ethanol 75 % Topical GelPSN0f0c79cb-88bf-4db4-b759-4c2ca81f2d591
1307051ethanol 0.75 ML/ML Medicated PadSCD0f0c79cb-88bf-4db4-b759-4c2ca81f2d591
1305100ethanol 0.75 ML/ML Topical GelSCD0f0c79cb-88bf-4db4-b759-4c2ca81f2d591
1307051ethanol 75 % Hand Sanitizer WipesSY0f0c79cb-88bf-4db4-b759-4c2ca81f2d591
1305100ethanol 75 % Topical GelSY0f0c79cb-88bf-4db4-b759-4c2ca81f2d591
1307051ethyl alcohol 75 % Topical ClothSY0f0c79cb-88bf-4db4-b759-4c2ca81f2d591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74934-001-617493400016160 BAG in 1 BOX (74934-001-61) > 2 mL in 1 BAG60 bag2020-06-140000-00-00NoNoCurrent