FDA.reportPublic FDA data

Klean Freak

Product NDC
78982-007
Requested package NDC
78982-007-01
11-digit product format
789820007
Labeler code
78982
Product ID
78982-007_44a80b28-bae3-14fe-e063-6294a90af95d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
KLEAN FREAK, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-30
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
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
Klean Freak
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g

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
87aaabb6-d121-464f-993d-5182de13d49eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78982-007-01Klean Freak4 g in 1 POUCHCLOTH42
78982-007-02Klean Freak44 g in 1 CANISTERCLOTH442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78982-007KLEAN FREAK (BENZALKONIUM CHLORIDE) CLOTH [KLEAN FREAK, LLC]1Current NDC, 2 package rows20240502_87aaabb6-d121-464f-993d-5182de13d49e.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 89 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
application number: M003
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN87aaabb6-d121-464f-993d-5182de13d49e2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD87aaabb6-d121-464f-993d-5182de13d49e2
1038558benzalkonium chloride 0.13 % Topical ClothSY87aaabb6-d121-464f-993d-5182de13d49e2
1038558benzalkonium chloride 0.13 % Topical SwabSY87aaabb6-d121-464f-993d-5182de13d49e2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY87aaabb6-d121-464f-993d-5182de13d49e2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY87aaabb6-d121-464f-993d-5182de13d49e2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY87aaabb6-d121-464f-993d-5182de13d49e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78982-007-01789820007014 g in 1 POUCH (78982-007-01) 4 g2024-04-30NoNoCurrent