FDA.reportPublic FDA data

Premium Hand Sanitizer

Product NDC
68599-5201
11-digit product format
685995201
Labeler code
68599
Product ID
68599-5201_2731720b-d98c-9dbf-e063-6394a90a054a
Type
HUMAN OTC DRUG
Nonproprietary name
ethanol
Dosage form
GEL
Route
TOPICAL
Labeler
MCKESSON MEDICAL-SURGICAL INC.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-09
Substance
ALCOHOL
Active strength
70 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage68599-520168599-5201-1DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Premium Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9514466-e0c6-4792-984a-9f07d94ee887Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5201-1Premium Hand Sanitizer118 g in 1 PACKAGEGEL1188
68599-5201-2Premium Hand Sanitizer237 g in 1 PACKAGEGEL2378
68599-5201-3Premium Hand Sanitizer532 g in 1 PACKAGEGEL5328
68599-5201-4Premium Hand Sanitizer1000 g in 1 PACKAGEGEL10008

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
ALCOHOLACTIVE MOIETY3K9958V90MPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
DIISOPROPYL SEBACATEINACTIVE INGREDIENTJ8T3X564IHPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8PREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5201PREMIUM HAND SANITIZER (ETHANOL) GEL [MCKESSON MEDICAL-SURGICAL INC.]8Current NDC, Legacy NDC, 4 package rows20241120_a9514466-e0c6-4792-984a-9f07d94ee887.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 106 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Antibacterial Hand Cleanse Strawberry PomegranateTRICLOSANRejoice International, Inc.b68a7d64-2650-4fc6-a89e-05de9098a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Mountain SpringTRICLOSANRejoice International, Inc.c31723d5-a313-448a-8b69-ca5f8dec25ed2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice Internationala9a1467c-abcc-4ccb-88f6-4302796097882024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice International9fa9d955-7167-4a0a-935b-2a600f439eb02024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International157a14bf-f46e-49f8-96f4-a6c472eb5cb82024-02-28WarningsExact identifier
application number: M003
XtraCare Foaming Hand SanitizerBENZALKONIUM CHLORIDERejoice International3082cbbb-a0ed-45eb-a116-ad1c65357dd12024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry BlastBENZALKONIUM CHLORIDERejoice International45b3ca49-edb4-4840-b857-d24045494a3a2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International4890f81e-7994-4ea2-9412-5614c405a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry BlastBENZALKONIUM CHLORIDERejoice International5c109f7c-1f4d-484a-b6ea-3bbcf572bbac2024-02-28WarningsExact identifier
application number: M003
XtraCare Hand Sanitizer Moisurize with Vitamin E and AloeETHYL ALCOHOLRejoice International2851ad2a-e108-424c-86d6-c898567695ef2024-02-28WarningsExact identifier
application number: M003
XtraCare Hand Sanitizer Moisturize with Vitamin EETHYL ALCOHOLRejoice International13c99570-0859-4310-843a-5eb266698eb32024-02-28WarningsExact identifier
application number: M003
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationala339dfd9-7cb8-4198-bc2a-9759648cf34e2024-02-28WarningsExact identifier
application number: M003
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationalf15a90e2-4a1e-452a-b9ac-5eb6f7b3dc722024-02-28WarningsExact identifier
application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd11ef87cc-6ff6-511b-e063-6294a90a662f2024-02-21WarningsExact identifier
application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLMY IMPORTS USA LLC11f19126-6abb-b14c-e063-6294a90a4e342024-02-21WarningsExact identifier
application number: M003
AntisepticANTISEPTIC SPRAYDynarex Corporation118192ac-7173-09c5-e063-6394a90ad5502024-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOL SPRAYDynarex Corporation116e0c9c-cbe0-bf67-e063-6394a90ae5302024-02-15WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEHART Health92b6a38e-c7bb-45e2-9c2a-7993ed1bac362024-02-15WarningsExact identifier
application number: M003
Povidone Iodine Gel SwabstickPOVIDONE IODINE GEL SWABSTICKDynarex Corporationeb7e21be-521e-2d52-e053-2a95a90ade332024-02-13WarningsExact identifier
application number: M003
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa9514466-e0c6-4792-984a-9f07d94ee8878
581662ethanol 0.7 ML/ML Topical GelSCDa9514466-e0c6-4792-984a-9f07d94ee8878
581662ethanol 70 % Topical GelSYa9514466-e0c6-4792-984a-9f07d94ee8878
581662ethyl alcohol 70 % Topical GelSYa9514466-e0c6-4792-984a-9f07d94ee8878

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-5201-168599520101118 g in 1 PACKAGE (68599-5201-1) 118 g2015-01-090000-00-00NoNoCurrent
68599-5201-268599520102237 g in 1 PACKAGE (68599-5201-2) 237 g2015-01-090000-00-00NoNoCurrent
68599-5201-368599520103532 g in 1 PACKAGE (68599-5201-3) 532 g2015-01-090000-00-00NoNoCurrent
68599-5201-4685995201041000 g in 1 PACKAGE (68599-5201-4) 1000 g2015-01-090000-00-00NoNoCurrent