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
BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE
Active strength
.05; .05 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
anzoon ANTISEPTIC WIPES
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, PH41D05744

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

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 container2026-04-27NoNoHistorical
87638-001-028763800010210 CONTAINER in 1 CONTAINER (87638-001-02) / 100 mL in 1 CONTAINER10 container2026-04-27NoNoHistorical
87638-001-038763800010320 CONTAINER in 1 CONTAINER (87638-001-03) / 200 mL in 1 CONTAINER20 container2026-04-27NoNoHistorical
87638-001-048763800010430 CONTAINER in 1 CONTAINER (87638-001-04) / 300 mL in 1 CONTAINER30 container2026-04-27NoNoHistorical
87638-001-058763800010550 CONTAINER in 1 CONTAINER (87638-001-05) / 500 mL in 1 CONTAINER50 container2026-04-27NoNoHistorical
87638-001-068763800010680 CONTAINER in 1 CONTAINER (87638-001-06) / 800 mL in 1 CONTAINER80 container2026-04-27NoNoHistorical
87638-001-0787638000107100 CONTAINER in 1 CONTAINER (87638-001-07) / 1000 mL in 1 CONTAINER100 container2026-04-27NoNoHistorical
87638-001-0887638000108500 CONTAINER in 1 CONTAINER (87638-001-08) / 5000 mL in 1 CONTAINER500 container2026-04-27NoNoHistorical
87638-001-0987638000109800 CONTAINER in 1 CONTAINER (87638-001-09) / 8000 mL in 1 CONTAINER800 container2026-04-27NoNoHistorical
87638-001-10876380001101000 CONTAINER in 1 CONTAINER (87638-001-10) / 10000 mL in 1 CONTAINER1000 container2026-04-27NoNoHistorical