FDA.reportPublic FDA data

Benzalkonium Chloride

Product NDC
78691-140
11-digit product format
786910140
Labeler code
78691
Product ID
78691-140_453a5e32-8a03-f152-e063-6294a90a3087
Type
HUMAN OTC DRUG
Nonproprietary name
Antibacterial Hand Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
Quest USA Corp
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-04
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/1001
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
Benzalkonium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/1001

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
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9ab219d-07e3-2019-e053-2a95a90a1668Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-140-04Benzalkonium Chloride1400 in 1 CONTAINERCLOTH140011
78691-140-06Benzalkonium Chloride1600 in 1 CONTAINERCLOTH160011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78691-140BENZALKONIUM CHLORIDE (ANTIBACTERIAL HAND WIPES) CLOTH [QUEST USA CORP]10Current NDC, Legacy NDC, 2 package rows20241211_d9ab219d-07e3-2019-e053-2a95a90a1668.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 83 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEUniversal Distribution Center LLC2f98ba8c-0ab1-e256-e063-6394a90abe8f2025-03-05WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
application number: M003
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
application number: M003
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
application number: M003
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact identifier
application number: M003
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNd9ab219d-07e3-2019-e053-2a95a90a166811
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDd9ab219d-07e3-2019-e053-2a95a90a166811
1038558benzalkonium chloride 0.13 % Topical ClothSYd9ab219d-07e3-2019-e053-2a95a90a166811
1038558benzalkonium chloride 0.13 % Topical SwabSYd9ab219d-07e3-2019-e053-2a95a90a166811
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYd9ab219d-07e3-2019-e053-2a95a90a166811
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYd9ab219d-07e3-2019-e053-2a95a90a166811
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYd9ab219d-07e3-2019-e053-2a95a90a166811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78691-140-04786910140041400 CLOTH in 1 CONTAINER (78691-140-04) 1400 cloth2022-03-040000-00-00NoNoCurrent
78691-140-06786910140061600 CLOTH in 1 CONTAINER (78691-140-06) 1600 cloth2022-03-040000-00-00NoNoCurrent