FDA.reportPublic FDA data

Advanced Hand Sanitizer

Product NDC
49348-477
Requested package NDC
49348-477-37
11-digit product format
493480477
Labeler code
49348
Product ID
49348-477_da7b22ea-7790-440e-90b9-643d4665931a
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-12-17
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
700 mg/mL
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 packagepackage49348-47749348-477-37DDiscontinued by firm2026-10-12

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-47749348-477-37DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-477-37ML - Milliliter49348-477dfcc089f-f94a-44a8-9c7b-2ec23f08bb0512014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
ALCOHOLACTIVE MOIETY3K9958V90MADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
GLYCERYL CAPRYLATE/CAPRATEINACTIVE INGREDIENTG7515SW10NADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4KADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-477ADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [STRATEGIC SOURCING SERVICES LLC]14Legacy NDC20240929_81c9bfe3-cf7a-4ed4-bdee-d3bd961228da.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-477-3749348047737236 mL in 1 BOTTLE, PUMP (49348-477-37) 236 ml2012-12-170000-00-00NoNoCurrent