FDA.reportPublic FDA data

Klean Freak

Product NDC
78982-002
11-digit product format
789820002
Labeler code
78982
Product ID
78982-002_44a7930e-ebfc-2260-e063-6394a90a6ff6
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
2020-05-20
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
2298e131-3b0c-4104-bf48-5c366d763d45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78982-002-01Klean Freak4 g in 1 POUCHCLOTH44
78982-002-02Klean Freak44 g in 1 CANISTERCLOTH444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78982-002KLEAN FREAK (BENZALKONIUM CHLORIDE) CLOTH [KLEAN FREAK, LLC]3Current NDC, Legacy NDC, 2 package rows20231020_2298e131-3b0c-4104-bf48-5c366d763d45.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 46 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af27a7-3df9-270a-e063-6394a90abc7d2026-01-05WarningsExact identifier
application number: M003
Hand SanitiserALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a44d82bf-68a3-56bc-e053-2995a90ae5262026-01-05WarningsExact identifier
application number: M003
Green Island SanitiserALCOHOLZhejiang Guoyao Aerosol Co., Ltda7d1df16-3566-badf-e053-2a95a90aa61a2026-01-05WarningsExact identifier
application number: M003
Green IslandETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a7443a72-6ee5-07f7-e053-2995a90a33412026-01-05WarningsExact identifier
application number: M003
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8bc5da3-8660-6343-e053-2995a90ac9052026-01-05WarningsExact identifier
application number: M003
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8c0c9ce-05ac-0f33-e053-2a95a90ab8ed2026-01-05WarningsExact identifier
application number: M003
H2OneETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a9bcecf7-7767-69b4-e053-2995a90a92472026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af97d6-ae84-adfe-e063-6394a90aa7772026-01-05WarningsExact identifier
application number: M003
Healing SolutionsETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a9bf73d9-9eb2-5e12-e053-2995a90a03322026-01-05WarningsExact identifier
application number: M003
PFAETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.bc91087d-5976-e922-e053-2995a90ae2ac2026-01-05WarningsExact identifier
application number: M003
American Red Cross 70% Ethyl Alcohol Hand SanitizerETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltdf6bf5c5a-4954-4030-e053-6394a90a9cba2026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.03f88721-92a5-1453-e063-6294a90a15912026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04064c4d-e810-28ff-e063-6394a90a39832026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04064b0b-6f21-9ca4-e063-6294a90a85e22026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.05204974-88f3-84ce-e063-6394a90a326b2026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04fe378d-ee1e-ad52-e063-6294a90ae1462026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.04fe16d8-1824-34fe-e063-6394a90a7ab12026-01-05WarningsExact identifier
application number: M003
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbc45c1-c7e8-bded-e063-6394a90a31d12026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Monster JamALCOHOLShenzhen Lantern Scicence Co.,Ltd.47afe5bd-5e06-7300-e063-6294a90a94e82026-01-05WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer watermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.479b898c-0dff-98fe-e063-6294a90ade202026-01-04WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2298e131-3b0c-4104-bf48-5c366d763d454
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2298e131-3b0c-4104-bf48-5c366d763d454
1038558benzalkonium chloride 0.13 % Topical ClothSY2298e131-3b0c-4104-bf48-5c366d763d454
1038558benzalkonium chloride 0.13 % Topical SwabSY2298e131-3b0c-4104-bf48-5c366d763d454
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2298e131-3b0c-4104-bf48-5c366d763d454
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2298e131-3b0c-4104-bf48-5c366d763d454
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2298e131-3b0c-4104-bf48-5c366d763d454

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78982-002-01789820002014 g in 1 POUCH (78982-002-01) 4 g2020-05-200000-00-00NoNoCurrent
78982-002-027898200020244 g in 1 CANISTER (78982-002-02) 44 g2020-05-200000-00-00NoNoCurrent