FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
58228-8691
Requested package NDC
58228-8691-1
11-digit product format
582288691
Labeler code
58228
Product ID
58228-8691_46016e66-943e-e708-e063-6394a90a04ff
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
ProStat First Aid LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-08
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

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
0e21f466-d6ed-79c4-e063-6394a90ae988Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-8691-1Hand Sanitizer10 in 1 BAGGEL103
58228-8691-1Hand Sanitizer2000 in 1 CASEGEL20003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-8691HAND SANITIZER GEL [PROSTAT FIRST AID LLC]2Current NDC, 2 package rows20241127_0e21f466-d6ed-79c4-e063-6394a90ae988.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 1 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIOPURE50CT ANTI BACTERIAL HAND WIPESBIOPURE50CT ANTI BACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd57d3e290-1343-4075-e063-6394a90a41a62026-07-30WarningsExact identifier
application number: M003
Meridian Unwrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.c2d13d97-99ce-4a24-bdd6-684fbbf242a42026-07-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio BruleeALCOHOLShenzhen Lantern Scicence Co.,Ltd.57bd148e-f9eb-dfb6-e063-6394a90a1e122026-07-29WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-07-29WarningsExact identifier
application number: M003
Jelly SmackBENZALKONIUM CHLORIDEVULCAN MICROBIAL CORPORATIONeb79e11a-6c29-556b-e053-2a95a90a728a2026-07-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.57cb54f7-07be-524f-e063-6294a90a2c942026-07-29WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-07-29WarningsExact identifier
application number: M003
Meridian wrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.de60d4d5-87bc-4400-94e2-8307a9bb08702026-07-29WarningsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions57ac6fef-21de-e214-e063-6394a90a6c9e2026-07-28WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC57acc1ff-2564-1e61-e063-6394a90a3c912026-07-28WarningsExact identifier
application number: M003
It Bag Vanilla Sugar Hand SanitizerALCOHOLScent Theory Products LLC57adcf08-9785-016d-e063-6294a90aa8d42026-07-28WarningsExact identifier
application number: M003
It Bag Cherry Kiss Hand SanitizerALCOHOLScent Theory Products LLC57adec54-6099-0694-e063-6394a90a4a0f2026-07-28WarningsExact identifier
application number: M003
It Bag Strawberry Love Hand SanitizerALCOHOLScent Theory Products LLC57adfb22-cb7a-39e7-e063-6294a90a30792026-07-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Pouch-Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b6f063-9afa-94c9-e063-6394a90a2c352026-07-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Lavender VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b7250c-49cd-3076-e063-6294a90ab7572026-07-28WarningsExact identifier
application number: M003
Magicare alcohol hand sanitizing wipesALCOHOL HAND SANITIZING WIPESGuangzhou Baihua Co., Ltd57b7531b-77f7-f63b-e063-6394a90aa81c2026-07-28WarningsExact identifier
application number: M003
Magicare alcohol hand sanitizing wipesALCOHOL HAND SANITIZING WIPESGuangzhou Baihua Co., Ltd57b7b74e-6df9-4384-e063-6394a90a09c42026-07-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fig VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b7b91f-1874-f2f0-e063-6294a90a40602026-07-28WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b7f5fd-0472-3a84-e063-6294a90adb9e2026-07-28WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEMeijer Distribution Inc036fd504-0cda-60ab-e063-6394a90a2f182026-07-27WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN0e21f466-d6ed-79c4-e063-6394a90ae9883
581662ethanol 0.7 ML/ML Topical GelSCD0e21f466-d6ed-79c4-e063-6394a90ae9883
581662ethanol 70 % Topical GelSY0e21f466-d6ed-79c4-e063-6394a90ae9883
581662ethyl alcohol 70 % Topical GelSY0e21f466-d6ed-79c4-e063-6394a90ae9883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-8691-1582288691012000 BAG in 1 CASE (58228-8691-1) / 10 PACKET in 1 BAG / 1.01 mL in 1 PACKET2000 bag2024-01-08NoNoCurrent