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
POLIHEXANIDE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength
.04; .05 U/100U; U/100U
NDC exclude flag
No
Listing certified through
2026-12-31
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
Cleansing Wipes
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4XI6112496Internal 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
43d6041f-18d1-b0e3-e063-6294a90a7c79Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cleansing WipesCLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD43d6041f-18d1-b0e3-e063-6294a90a7c792025-11-17WarningsExact identifier
ndc (product): 43116-047

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 u2025-11-18NoNoCurrent
43116-047-024311600470210 U in 1 BOX (43116-047-02) 10 u2025-11-18NoNoCurrent
43116-047-034311600470330 U in 1 BOX (43116-047-03) 30 u2025-11-18NoNoCurrent
43116-047-044311600470460 U in 1 BOX (43116-047-04) 60 u2025-11-18NoNoCurrent