FDA.reportPublic FDA data

Klean Freak

Product NDC
78982-005
11-digit product format
789820005
Labeler code
78982
Product ID
78982-005_44a7fcb2-6051-b3fc-e063-6394a90a9247
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
cef2d3d4-bd5f-4f2a-bb2d-5292b78501c1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78982-005-01Klean Freak4 g in 1 POUCHCLOTH44
78982-005-02Klean Freak44 g in 1 CANISTERCLOTH444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78982-005KLEAN FREAK (BENZALKONIUM CHLORIDE) CLOTH [KLEAN FREAK, LLC]3Current NDC, Legacy NDC, 2 package rows20231020_cef2d3d4-bd5f-4f2a-bb2d-5292b78501c1.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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNcef2d3d4-bd5f-4f2a-bb2d-5292b78501c14
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDcef2d3d4-bd5f-4f2a-bb2d-5292b78501c14
1038558benzalkonium chloride 0.13 % Topical ClothSYcef2d3d4-bd5f-4f2a-bb2d-5292b78501c14
1038558benzalkonium chloride 0.13 % Topical SwabSYcef2d3d4-bd5f-4f2a-bb2d-5292b78501c14
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYcef2d3d4-bd5f-4f2a-bb2d-5292b78501c14
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYcef2d3d4-bd5f-4f2a-bb2d-5292b78501c14
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYcef2d3d4-bd5f-4f2a-bb2d-5292b78501c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78982-005-01789820005014 g in 1 POUCH (78982-005-01) 4 g2020-05-200000-00-00NoNoCurrent
78982-005-027898200050244 g in 1 CANISTER (78982-005-02) 44 g2020-05-200000-00-00NoNoCurrent