FDA.reportPublic FDA data

anzoon ANTISEPTIC WIPES

Product NDC
87638-001
11-digit product format
876380001
Labeler code
87638
Product ID
87638-001_506cd089-f9a8-d9e5-e063-6394a90af696
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride/Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Shandong ACZ Biotechnology Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-27
Substance
BENZETHONIUM CHLORIDE; BENZALKONIUM CHLORIDE
Active strength
.05; .05 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
anzoon ANTISEPTIC WIPES
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.05 g/100mL
BENZALKONIUM CHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup
F5UM2KM3W7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
506cd089-f9a7-d9e5-e063-6394a90af696Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87638-001-01anzoon ANTISEPTIC WIPES1 in 1 CONTAINERCLOTH11
87638-001-01anzoon ANTISEPTIC WIPES10 mL in 1 CONTAINERCLOTH101
87638-001-02anzoon ANTISEPTIC WIPES10 in 1 CONTAINERCLOTH101
87638-001-02anzoon ANTISEPTIC WIPES100 mL in 1 CONTAINERCLOTH1001
87638-001-03anzoon ANTISEPTIC WIPES20 in 1 CONTAINERCLOTH201
87638-001-03anzoon ANTISEPTIC WIPES200 mL in 1 CONTAINERCLOTH2001
87638-001-04anzoon ANTISEPTIC WIPES30 in 1 CONTAINERCLOTH301
87638-001-04anzoon ANTISEPTIC WIPES300 mL in 1 CONTAINERCLOTH3001
87638-001-05anzoon ANTISEPTIC WIPES500 mL in 1 CONTAINERCLOTH5001
87638-001-05anzoon ANTISEPTIC WIPES50 in 1 CONTAINERCLOTH501
87638-001-06anzoon ANTISEPTIC WIPES800 mL in 1 CONTAINERCLOTH8001
87638-001-06anzoon ANTISEPTIC WIPES80 in 1 CONTAINERCLOTH801
87638-001-07anzoon ANTISEPTIC WIPES100 in 1 CONTAINERCLOTH1001
87638-001-07anzoon ANTISEPTIC WIPES1000 mL in 1 CONTAINERCLOTH10001
87638-001-08anzoon ANTISEPTIC WIPES500 in 1 CONTAINERCLOTH5001
87638-001-08anzoon ANTISEPTIC WIPES5000 mL in 1 CONTAINERCLOTH50001
87638-001-09anzoon ANTISEPTIC WIPES8000 mL in 1 CONTAINERCLOTH80001
87638-001-09anzoon ANTISEPTIC WIPES800 in 1 CONTAINERCLOTH8001
87638-001-10anzoon ANTISEPTIC WIPES10000 mL in 1 CONTAINERCLOTH100001
87638-001-10anzoon ANTISEPTIC WIPES1000 in 1 CONTAINERCLOTH10001

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 47 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic wipeBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.fc4fc127-3130-4891-b390-6dc823cb30d42026-01-01WarningsExact identifier
application number: M003
Iodine Prep Pad AntisepticPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.0fdded64-4e89-d28c-e063-6394a90a7b8f2026-01-01WarningsExact identifier
application number: M003
OP First Aid Series Alcohol Prep PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co., Ltd.b3da7cff-4555-358e-e053-2995a90ae0ff2026-01-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAstera International LLCa5189240-19ce-7715-e053-2995a90ad0432025-12-31WarningsExact identifier
application number: M003
Water Jel Hydrogen PeroxideHYDROGEN PEROXIDEWater-Jel Technologiesf508c3cb-e162-4d11-9513-ff44918f82c02025-12-31WarningsExact identifier
application number: M003
HEB 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLHEB Grocery Companye8dd7f84-3690-4ab3-a21f-43bf66984f4b2025-12-30WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
application number: M003
AntisepticBENZETHONIUM CHLORIDEMPM Medical, LLC3f660269-f83d-4f71-9a70-e2ddb2c57ec62025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
application number: M003
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
application number: M003
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
application number: M003
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact identifier
application number: M003
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
application number: M003
GuardelleBENZALKONIUM CHLORIDESocial Medical Supply LLC8793e3be-7409-4f71-9397-abbeacd27cf82025-12-22WarningsExact identifier
application number: M003
CareALL First Aid Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLNew World Imports, Inc69eef888-0044-485c-96a1-247ed12048582025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Pear Blossom TeaALCOHOL SOLUTIONNoshinku46927edb-f8be-f0b9-e063-6294a90a8e562025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Santal BlancALCOHOL SOLUTIONNoshinku4692c807-268e-6477-e063-6394a90aac0a2025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Vanilla CremeALCOHOL SOLUTIONNoshinku4692e68c-2bc8-83f8-e063-6294a90a84e42025-12-22WarningsExact identifier
application number: M003
Alcohol sanitizer wipesALCOHOL/PURIFIED WATERSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.ab9634bd-4226-2f73-e053-2995a90a802f2025-12-19WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87638-001-01876380001011 CONTAINER in 1 CONTAINER (87638-001-01) / 10 mL in 1 CONTAINER1 container2026-04-27NoNoCurrent
87638-001-028763800010210 CONTAINER in 1 CONTAINER (87638-001-02) / 100 mL in 1 CONTAINER10 container2026-04-27NoNoCurrent
87638-001-038763800010320 CONTAINER in 1 CONTAINER (87638-001-03) / 200 mL in 1 CONTAINER20 container2026-04-27NoNoCurrent
87638-001-048763800010430 CONTAINER in 1 CONTAINER (87638-001-04) / 300 mL in 1 CONTAINER30 container2026-04-27NoNoCurrent
87638-001-058763800010550 CONTAINER in 1 CONTAINER (87638-001-05) / 500 mL in 1 CONTAINER50 container2026-04-27NoNoCurrent
87638-001-068763800010680 CONTAINER in 1 CONTAINER (87638-001-06) / 800 mL in 1 CONTAINER80 container2026-04-27NoNoCurrent
87638-001-0787638000107100 CONTAINER in 1 CONTAINER (87638-001-07) / 1000 mL in 1 CONTAINER100 container2026-04-27NoNoCurrent
87638-001-0887638000108500 CONTAINER in 1 CONTAINER (87638-001-08) / 5000 mL in 1 CONTAINER500 container2026-04-27NoNoCurrent
87638-001-0987638000109800 CONTAINER in 1 CONTAINER (87638-001-09) / 8000 mL in 1 CONTAINER800 container2026-04-27NoNoCurrent
87638-001-10876380001101000 CONTAINER in 1 CONTAINER (87638-001-10) / 10000 mL in 1 CONTAINER1000 container2026-04-27NoNoCurrent