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 58 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9c34be37-b6e2-4c08-96a5-d9bb0e738f2d2025-10-23WarningsExact identifier
application number: M003
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
application number: M003
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
application number: M003
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
application number: M003
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
application number: M003
Sting and BiteBENZOCAINEPHOENIX HEALTHCARE SOLUTIONS, LLC82791832-1357-48ca-91d4-1328997012612025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
application number: M003
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
application number: M003
Koala Eco Hand SanitizerETHYL ALCOHOLKoala Eco Company USA Ltd41d7d6e3-9961-770d-e063-6394a90a0d242025-10-23WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact 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