FDA.reportPublic FDA data

Hand Sanitizer plus Holder

Product NDC
78164-101
11-digit product format
781640101
Labeler code
78164
Product ID
78164-101_3f042aa7-7546-a06c-e063-6394a90aed31
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Gertex Hosiery
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 plus Holder
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a182eafa-0ce0-4b99-bcb0-23f9a8de9e1fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78164-101-35Hand Sanitizer plus Holder35 mL in 1 BOTTLELIQUID351

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 84 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand SanitizerINSTANT HAND SANITIZERRaining Rose, Inc2f37a2a1-5250-4052-e063-6294a90aef7f2025-02-28WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
application number: M003
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLWalgreens78ed5594-433a-4f90-ad39-51e2a7dd2e212025-02-21WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLWalgreens9effa6c9-020d-4a2d-ad26-449d4119b6a02025-02-21WarningsExact identifier
application number: M003
Isopropyl alcohol 50 percent Wintergreen ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCf9ff67b0-c4ad-4162-b3ef-27a85ed0da252025-02-18WarningsExact identifier
application number: M003
Inverness Home Ear Piercing KitBENZALKONIUM CHLORIDEThe Richline Group, Inc.80909a34-21da-4c54-bb62-fd986fd24b042025-02-17WarningsExact identifier
application number: M003
Inverness EAR CARE ANTISEPTICBENZALKONIUM CHLORIDEThe Richline Groupac42d2f1-69e3-45f6-8002-d45ebed5ee222025-02-17WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1507f1-a88f-4ef8-e063-6294a90a92fd2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e159f8f-352c-45ca-e063-6394a90adf9b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1633f1-4b59-6eea-e063-6294a90ae61b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Spider man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e16c9bc-223d-0c65-e063-6294a90a48152025-02-14WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.3007da5f-e2ea-4f3a-905c-770782da014e2025-02-14WarningsExact identifier
application number: M003
50 percent Isopropyl alcoholISOPROPYL ALCOHOLWhole Foods Market6cb4ccca-96e7-43cb-ae05-95a411e712552025-02-14WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78164-101-357816401013535 mL in 1 BOTTLE (78164-101-35) 35 ml2025-09-01NoNoCurrent