FDA.reportPublic FDA data

CLEANZ ECO BAMBOO WIPES

Product NDC
83061-001
11-digit product format
830610001
Labeler code
83061
Product ID
83061-001_46adff44-2979-1c1c-e063-6294a90a0727
Type
HUMAN OTC DRUG
Nonproprietary name
Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
McF Holdings LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-15
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLEANZ ECO BAMBOO WIPES
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83061-001-012025-02-21C16284748780-12cef2736-b4f3-d83d-e063-dadaa90ab31f83061-001 CLEANZ ECO BAMBOO WIPES
83061-001-022025-02-21C16284748780-12cef2736-b4f3-d83d-e063-dadaa90ab31f83061-001 CLEANZ ECO BAMBOO WIPES
83061-001-032025-02-21C16284748780-12cef2736-b4f3-d83d-e063-dadaa90ab31f83061-001 CLEANZ ECO BAMBOO WIPES
83061-001-012025-01-30C16284748780-12cef2736-b4f3-d83d-e063-dadaa90ab31f83061-001 CLEANZ ECO BAMBOO WIPES
83061-001-022025-01-30C16284748780-12cef2736-b4f3-d83d-e063-dadaa90ab31f83061-001 CLEANZ ECO BAMBOO WIPES
83061-001-032025-01-30C16284748780-12cef2736-b4f3-d83d-e063-dadaa90ab31f83061-001 CLEANZ ECO BAMBOO WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83061-001-01CLEANZ ECO BAMBOO WIPES0.00468 g in 1 POUCHCLOTH0.004689
83061-001-01CLEANZ ECO BAMBOO WIPES900 in 1 PACKAGECLOTH9009
83061-001-02CLEANZ ECO BAMBOO WIPES1000 in 1 PACKAGECLOTH10009
83061-001-02CLEANZ ECO BAMBOO WIPES0.00468 g in 1 POUCHCLOTH0.004689
83061-001-03CLEANZ ECO BAMBOO WIPES0.00468 g in 1 POUCHCLOTH0.004689
83061-001-03CLEANZ ECO BAMBOO WIPES1500 in 1 PACKAGECLOTH15009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83061-001CLEANZ ECO BAMBOO WIPES (WIPES) CLOTH [MCF HOLDINGS LLC]7Current NDC, Legacy NDC, 6 package rows20250223_eb85292a-41a3-67b0-e053-2a95a90ab461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNeb85292a-41a3-67b0-e053-2a95a90ab4619
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDeb85292a-41a3-67b0-e053-2a95a90ab4619
1038558benzalkonium chloride 0.13 % Topical ClothSYeb85292a-41a3-67b0-e053-2a95a90ab4619
1038558benzalkonium chloride 0.13 % Topical SwabSYeb85292a-41a3-67b0-e053-2a95a90ab4619
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYeb85292a-41a3-67b0-e053-2a95a90ab4619
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYeb85292a-41a3-67b0-e053-2a95a90ab4619
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYeb85292a-41a3-67b0-e053-2a95a90ab4619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83061-001-0183061000101900 POUCH in 1 PACKAGE (83061-001-01) / .00468 g in 1 POUCH900 pouch2022-10-150000-00-00NoNoCurrent
83061-001-02830610001021000 POUCH in 1 PACKAGE (83061-001-02) / .00468 g in 1 POUCH1000 pouch2022-10-150000-00-00NoNoCurrent
83061-001-03830610001031500 POUCH in 1 PACKAGE (83061-001-03) / .00468 g in 1 POUCH1500 pouch2022-10-15NoNoHistorical