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 14 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio GlowETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5570310b-c587-13aa-e063-6394a90a6c062026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt AirETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55726238-3b6b-55a2-e063-6394a90a570a2026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple SplashETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.555d7248-8cc8-fe70-e063-6294a90a69a42026-06-28WarningsExact identifier
application number: M003
COCONUT ANTIBACTERIAL HAND SANITIZERALCOHOLENCHANTE ACCESSORIES INC.270dcb5d-113b-4278-b61e-a8808846c8952026-06-27WarningsExact identifier
application number: M003
ORANGE CITRUS ANTIBACTERIAL HAND SANITIZERALCOHOLENCHANTE ACCESSORIES INC.86b77b42-53a1-4f9f-a607-18b1ddc04c442026-06-27WarningsExact identifier
application number: M003
Lights Alcohol WipesISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.f9601021-4c52-4b48-96c1-b25fe8fef8b12026-06-26WarningsExact identifier
application number: M003
WILD CHERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e958f-414d-9917-e063-6294a90aa9772026-06-26WarningsExact identifier
application number: M003
VANILLA HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552ebc73-6e43-3527-e063-6394a90af58a2026-06-26WarningsExact identifier
application number: M003
Lights Medium AlcoholISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.873e0c9d-e0aa-44bb-a1f4-4474584790232026-06-25WarningsExact identifier
application number: M003
MOUTAIN DEW HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fbbdde-ef7b-0a8b-e063-6294a90ad9e42026-06-24WarningsExact identifier
application number: M003
BAJA BLAST HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fc7e91-53f7-70b4-e063-6294a90ac0852026-06-24WarningsExact identifier
application number: M003
MISTIFY SEA SALT CARAMEL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fce390-6b53-f9f7-e063-6294a90aa44f2026-06-24WarningsExact identifier
application number: M003
MISTIFY CHERRY CRUSH HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0c49-bf20-c2e3-e063-6294a90a56402026-06-24WarningsExact identifier
application number: M003
MISTIFY VANILLA CUPCAKE HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0885-0d8c-614d-e063-6394a90acef92026-06-24WarningsExact identifier
application number: M003
CVS Povidone IodinePOVIDONE IODINECVS Pharmacy Inca8d754f4-a696-d0d9-e053-2a95a90a4aff2026-06-24WarningsExact identifier
application number: M003
MISTIFY SWEET STRAWBERRY HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd55042fdb-ce19-2396-e063-6394a90a99862026-06-24WarningsExact identifier
application number: M003
Smart Care Hand Sanitizers 2pk Apple and MarshmallowALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6b242-6f50-0e3e-e063-6294a90a52692026-06-23WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Silicone Holiday Gift Set 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6ecb7-5cd5-fc13-e063-6294a90a038c2026-06-23WarningsExact identifier
application number: M003
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD54e83df5-bbeb-d068-e063-6394a90ad5132026-06-23WarningsExact identifier
application number: M003
VANILL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54e9d23b-45e5-5e53-e063-6394a90a60662026-06-23WarningsExact 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