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 3 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a4ac18e-8ba5-bef6-e063-6394a90a88112026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a4d11fa-3f65-b41f-e063-6394a90a30ae2026-08-31WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry CobblerALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a52731b-5e8c-5ae6-e063-6394a90a8b042026-08-31WarningsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOLUpLift Brands, LLC8ae12375-3a95-475c-9600-17c51a9103f72026-08-31Warnings, Adverse reactionsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f875e065-7b3e-45dc-8a33-b893ab8306952026-08-31WarningsExact identifier
application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30e11bf0-1a21-45b1-adf9-cf3845419a982026-08-31WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59ed87d5-dab1-abab-e063-6394a90a024d2026-08-26WarningsExact 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