FDA.reportPublic FDA data

Three Cleansing

Product NDC
34645-0025
11-digit product format
346450025
Labeler code
34645
Product ID
34645-0025_1ab25717-7d6c-2fe6-e063-6394a90ab38b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SWAB
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-30
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Three Cleansing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

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
1ab25c0d-e616-30f7-e063-6294a90ad1e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0025-1Three Cleansing3 in 1 POUCHSWAB31
34645-0025-1Three Cleansing500 in 1 CARTONSWAB5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0025THREE CLEANSING (BENZALKONIUM CHLORIDE) SWAB [JIANERKANG MEDICAL CO., LTD]1Current NDC, 2 package rows20240613_1ab25c0d-e616-30f7-e063-6294a90ad1e4.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Three CleansingBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1ab25c0d-e616-30f7-e063-6294a90ad1e42024-06-12WarningsExact identifier
ndc (product): 34645-0025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1ab25c0d-e616-30f7-e063-6294a90ad1e41
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1ab25c0d-e616-30f7-e063-6294a90ad1e41
1038558benzalkonium chloride 0.13 % Topical ClothSY1ab25c0d-e616-30f7-e063-6294a90ad1e41
1038558benzalkonium chloride 0.13 % Topical SwabSY1ab25c0d-e616-30f7-e063-6294a90ad1e41
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1ab25c0d-e616-30f7-e063-6294a90ad1e41
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1ab25c0d-e616-30f7-e063-6294a90ad1e41
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1ab25c0d-e616-30f7-e063-6294a90ad1e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
34645-0025-134645002501500 POUCH in 1 CARTON (34645-0025-1) / 3 POUCH in 1 POUCH / 1.5 mL in 1 POUCH500 pouch2024-05-30NoNoCurrent