FDA.reportPublic FDA data

Cleansing Wipes

Product NDC
43116-047
11-digit product format
431160047
Labeler code
43116
Product ID
43116-047_43d6041f-18d2-b0e3-e063-6294a90a7c79
Type
HUMAN OTC DRUG
Nonproprietary name
Cleansing Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
Shenzhen Shierjie Biological Engineering Co., LTD
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-18
Substance
BENZALKONIUM CHLORIDE; POLIHEXANIDE HYDROCHLORIDE
Active strength
.05; .04 U/100U; U/100U
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLIHEXANIDE HYDROCHLORIDE.05 U/100U
BENZALKONIUM CHLORIDE.04 U/100U

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4XI6112496, F5UM2KM3W7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43116-047-01Cleansing Wipes1 U in 1 POUCHCLOTH11
43116-047-02Cleansing Wipes10 U in 1 BOXCLOTH101
43116-047-03Cleansing Wipes30 U in 1 BOXCLOTH301
43116-047-04Cleansing Wipes60 U in 1 BOXCLOTH601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43116-047-01431160047011 U in 1 POUCH (43116-047-01) 1 u2025-11-18NoNoHistorical
43116-047-024311600470210 U in 1 BOX (43116-047-02) 10 u2025-11-18NoNoHistorical
43116-047-034311600470330 U in 1 BOX (43116-047-03) 30 u2025-11-18NoNoHistorical
43116-047-044311600470460 U in 1 BOX (43116-047-04) 60 u2025-11-18NoNoHistorical