Home NDC 43116-036 Wet wipes
Product NDC 43116-036
11-digit product format 431160036
Labeler code 43116
Product ID 43116-036_47d86d77-f61f-4215-e063-6394a90a3565
Type HUMAN OTC DRUG
Nonproprietary name Wet wipes
Dosage form CLOTH
Route TOPICAL
Labeler Shenzhen Shierjie Biological Engineering Co., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-19
Substance DIDECYLDIMONIUM CHLORIDE; BENZETHONIUM CHLORIDE
Active strength .2; .05 U/100U; U/100U
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 Wet wipes
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIDECYLDIMONIUM CHLORIDE .2 U/100U BENZETHONIUM CHLORIDE .05 U/100U
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JXN40O9Y9B Internal UNII lookup PH41D05744 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43116-036-01 Wet wipes 1 U in 1 BOX CLOTH 1 2 43116-036-02 Wet wipes 20 U in 1 BOX CLOTH 20 2 43116-036-03 Wet wipes 50 U in 1 BOX CLOTH 50 2 43116-036-04 Wet wipes 100 U in 1 BOX CLOTH 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43116-036 WET WIPES CLOTH [SHENZHEN SHIERJIE BIOLOGICAL ENGINEERING CO., LTD] 1 Current NDC, 4 package rows 20241127_273b3ae2-6dec-31a4-e063-6294a90aca89.zip
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 36 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43116-036-01 43116003601 1 U in 1 BOX (43116-036-01) 1 u 2024-11-19 No No Current 43116-036-02 43116003602 20 U in 1 BOX (43116-036-02) 20 u 2024-11-19 No No Current 43116-036-03 43116003603 50 U in 1 BOX (43116-036-03) 50 u 2024-11-19 No No Current 43116-036-04 43116003604 100 U in 1 BOX (43116-036-04) 100 u 2024-11-19 No No Current