FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
77238-231
11-digit product format
772380231
Labeler code
77238
Product ID
77238-231_463d3fcf-70c1-f717-e063-6394a90a3612
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
DGH Pharma, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 3 · 126 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77238-231-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77238-231-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77238-231-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77238-231-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77238-231-41d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77238-231-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77238-231-44d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77238-231-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77238-231-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77238-231-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77238-231-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77238-231-41f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77238-231-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77238-231-44f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77238-231-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77238-231-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77238-231-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77238-231-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77238-231-412ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77238-231-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77238-231-442ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77238-231-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77238-231-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77238-231-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77238-231-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77238-231-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77238-231-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77238-231-44a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage77238-231-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage77238-231-11cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage77238-231-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage77238-231-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage77238-231-41cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage77238-231-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage77238-231-44cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage77238-231-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage77238-231-11cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage77238-231-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage77238-231-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage77238-231-41cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage77238-231-48cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage77238-231-44cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77238-231-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77238-231-11302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77238-231-24302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77238-231-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77238-231-41302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77238-231-48302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77238-231-44302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage77238-231-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage77238-231-11ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage77238-231-24ed331223b511…672a5bd82f5f…

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
Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049228Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae4311f8-fc40-38a7-e053-2a95a90ae829Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
77238-231-112024-01-30Hand Sanitizer Cu - 32015
77238-231-112024-01-30Hand Sanitizer Cu - 32015
77238-231-142024-01-30Hand Sanitizer Cu - 32015
77238-231-142024-01-30Hand Sanitizer Cu - 32015
77238-231-242024-01-30Hand Sanitizer Cu - 32015
77238-231-242024-01-30Hand Sanitizer Cu - 32015
77238-231-312024-01-30Hand Sanitizer Cu - 32015
77238-231-312024-01-30Hand Sanitizer Cu - 32015
77238-231-412024-01-30Hand Sanitizer Cu - 32015
77238-231-412024-01-30Hand Sanitizer Cu - 32015
77238-231-442024-01-30Hand Sanitizer Cu - 32015
77238-231-442024-01-30Hand Sanitizer Cu - 32015
77238-231-482024-01-30Hand Sanitizer Cu - 32015
77238-231-482024-01-30Hand Sanitizer Cu - 32015
77238-231-142022-07-29Hand Sanitizer Cu - 32015
77238-231-142022-07-29Hand Sanitizer Cu - 32015
77238-231-242022-07-29Hand Sanitizer Cu - 32015
77238-231-242022-07-29Hand Sanitizer Cu - 32015
77238-231-142022-01-28Hand Sanitizer Cu - 32015
77238-231-142022-01-28Hand Sanitizer Cu - 32015
77238-231-242022-01-28Hand Sanitizer Cu - 32015
77238-231-242022-01-28Hand Sanitizer Cu - 32015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77238-231-11Hand Sanitizer30 mL in 1 BOTTLE, SPRAYGEL304
77238-231-14Hand Sanitizer118 mL in 1 BOTTLEGEL1184
77238-231-24Hand Sanitizer118 mL in 1 BOTTLEGEL1184
77238-231-31Hand Sanitizer30 mL in 1 BOTTLE, SPRAYGEL304
77238-231-41Hand Sanitizer30 mL in 1 BOTTLE, SPRAYGEL304
77238-231-44Hand Sanitizer118 mL in 1 BOTTLEGEL1184
77238-231-48Hand Sanitizer3785 mL in 1 JUGGEL37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77238-231HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [DGH PHARMA, INC.]4Current NDC, Legacy NDC, 7 package rows20220731_ae4311f8-fc40-38a7-e053-2a95a90ae829.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 68 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUniforst First Aid Corporation5744f9a2-35c6-37df-e053-2991aa0a1ca92025-09-08WarningsExact identifier
application number: M003
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd2ccdd9a-469e-18eb-e053-2995a90a11962025-09-08WarningsExact identifier
application number: M003
Medi-First Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce650cb6-5398-29e7-e053-2995a90ac7972025-09-08WarningsExact identifier
application number: M003
MediFirst Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation8d17a840-b655-4e03-bc16-8ba033c3368d2025-09-08WarningsExact identifier
application number: M003
Medi-First Sting ReliefBENZOCAINE 6%, ISOPROPYL ALCOHOL 60%Unifirst First Aid Corporation6e610821-b030-930b-e053-2a91aa0a66f92025-09-08WarningsExact identifier
application number: M003
Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation81363387-d4b1-4c3f-b67f-5017361c0fcd2025-09-08WarningsExact identifier
application number: M003
Medi-First Isopropyl AlcoholISOPROPYL ALCOHOLUnifirst First Aid Corporationdbee035e-094f-f8a3-e053-2995a90a66202025-09-08WarningsExact identifier
application number: M003
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbfbf8cf-201b-2277-e053-2995a90a6e452025-09-08WarningsExact identifier
application number: M003
Medi-First PVP Iodine WipesPOVIDONE IODINE 10%Unifirst-First Aid406b4a37-816a-5ea4-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation7560c80b-8952-4748-af3a-20e3d42556952025-09-08WarningsExact identifier
application number: M003
Green Guard Derma-Caine BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation67629392-7e02-321a-e053-2991aa0a0f242025-09-08WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb3ef1ef5-1f6f-874a-e053-2995a90a32b12025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationa0f58025-2c50-45dc-94db-cacbd4cf604c2025-09-08WarningsExact identifier
application number: M003
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
application number: M003
Green Guard Antimicrobial TowelettesETHYL ALCOHOL 66.5%Unifirst First Aid Corporation6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c52025-09-08WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationb4627f3f-6282-51bf-e053-2a95a90a3d592025-09-08WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb463d09c-4b33-3774-e053-2a95a90a046b2025-09-08WarningsExact identifier
application number: M003
Thompson Burn Cream with LidocainBENZALKONIUM CHLORIDE, LIDOCAINEThompson Safety11729e6b-b911-5c1f-e063-6394a90a0c342025-09-08WarningsExact identifier
application number: M003
Thompson Hand SanitizerALCOHOL GELThompson06beaf35-f814-bf9b-e063-6294a90aec8c2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e41580a-64c5-480f-e063-6294a90a4bf12025-09-07WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSNae4311f8-fc40-38a7-e053-2a95a90ae8294
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCDae4311f8-fc40-38a7-e053-2a95a90ae8294
1049228benzalkonium chloride 0.1 % Topical GelSYae4311f8-fc40-38a7-e053-2a95a90ae8294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77238-231-117723802311130 mL in 1 BOTTLE, SPRAY (77238-231-11) 30 ml2020-09-010000-00-00NoNoCurrent
77238-231-1477238023114118 mL in 1 BOTTLE (77238-231-14) 118 ml2020-09-010000-00-00NoNoCurrent
77238-231-2477238023124118 mL in 1 BOTTLE (77238-231-24) 118 ml2020-10-060000-00-00NoNoCurrent
77238-231-317723802313130 mL in 1 BOTTLE, SPRAY (77238-231-31) 30 ml2022-06-010000-00-00NoNoCurrent
77238-231-417723802314130 mL in 1 BOTTLE, SPRAY (77238-231-41) 30 ml2022-07-010000-00-00NoNoCurrent
77238-231-4477238023144118 mL in 1 BOTTLE (77238-231-44) 118 ml2022-07-010000-00-00NoNoCurrent
77238-231-48772380231483785 mL in 1 JUG (77238-231-48) 3785 ml2022-07-010000-00-00NoNoCurrent