FDA.reportPublic FDA data

Hand-E XL

Product NDC
62257-606
11-digit product format
622570606
Labeler code
62257
Product ID
62257-606_239c502b-0bd7-4121-891f-0ce8c11e0b2c
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
ABC Compounding Co., Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-04-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62257-606DDiscontinued by firm2026-10-05
excluded packagepackage62257-60662257-606-17DDiscontinued by firm2026-10-05
excluded packagepackage62257-60662257-606-24DDiscontinued by firm2026-10-05
excluded packagepackage62257-60662257-606-28DDiscontinued by firm2026-10-05
excluded packagepackage62257-60662257-606-30DDiscontinued by firm2026-10-05

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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage62257-606-28
excluded packagepackage62257-606-30
excluded packagepackage62257-606-17
excluded packagepackage62257-606-24

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2
ALCOHOLACTIVE MOIETY3K9958V90MHAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8HAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208HAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2
DIISOPROPYLAMINEINACTIVE INGREDIENTBR9JLI40NOHAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62257-606HAND-E XL (ALCOHOL) GEL [ABC COMPOUNDING CO., INC.]4Legacy NDC20190101_ea0dd205-5f3d-40d6-9a75-b1b292e591a6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62257-606-1762257060617532 mL in 1 BOTTLE, PLASTIC (62257-606-17) 532 ml2005-04-010000-00-00NoNoCurrent
62257-606-2462257060624118 mL in 1 BOTTLE, PLASTIC (62257-606-24) 118 ml2005-04-010000-00-00NoNoCurrent
62257-606-2862257060628149 mL in 1 BOTTLE, PLASTIC (62257-606-28) 149 ml2005-04-010000-00-00NoNoCurrent
62257-606-3062257060630473 mL in 1 BOTTLE, PLASTIC (62257-606-30) 473 ml2005-04-010000-00-00NoNoCurrent