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 58 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
application number: M003
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
application number: M003
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
application number: M003
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
application number: M003
Sting and BiteBENZOCAINEPHOENIX HEALTHCARE SOLUTIONS, LLC82791832-1357-48ca-91d4-1328997012612025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
application number: M003
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
application number: M003
Koala Eco Hand SanitizerETHYL ALCOHOLKoala Eco Company USA Ltd41d7d6e3-9961-770d-e063-6394a90a0d242025-10-23WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact 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