Home NDC 58228-2011-1 Antiseptic Wipes
Product NDC 58228-2011
Requested package NDC 58228-2011-1
11-digit product format 582282011
Labeler code 58228
Product ID 58228-2011_5ed34185-f258-71ab-e063-6294a90ab4e3
Type HUMAN OTC DRUG
Nonproprietary name Antiseptic Wipes
Dosage form SWAB
Route TOPICAL
Labeler ProStat First Aid LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-08
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
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 Antiseptic Wipes
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58228-2011-1 Antiseptic Wipes 480 in 1 CASE SWAB 480 3 58228-2011-1 Antiseptic Wipes 20 in 1 BOX SWAB 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58228-2011 ANTISEPTIC WIPES SWAB [PROSTAT FIRST AID LLC] 2 Current NDC, 2 package rows 20241127_0e11238b-e5f2-075f-e063-6394a90aa825.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 85 of 114 · 2,270 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58228-2011-1 58228201101 480 BOX in 1 CASE (58228-2011-1) / 20 POUCH in 1 BOX / .55 mL in 1 POUCH 480 box 2024-01-08 No No Current