Home NDC 84219-004 Antiseptic Towelette TOALLITAS ANTISEPTICAS
Product NDC 84219-004
11-digit product format 842190004
Labeler code 84219
Product ID 84219-004_1507887f-14cc-8244-e063-6394a90aeaeb
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE
Dosage form CLOTH
Route TOPICAL
Labeler M-star (Hubei) Health&Care Products Co., Ltd.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-15
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/g
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 Towelette TOALLITAS ANTISEPTICAS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038558 Internal RxNorm 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 84219-004-00 Antiseptic Towelette TOALLITAS ANTISEPTICAS 1 in 1 POUCH CLOTH 1 1 84219-004-00 Antiseptic Towelette TOALLITAS ANTISEPTICAS 1 g in 1 PATCH CLOTH 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84219-004 ANTISEPTIC TOWELETTE TOALLITAS ANTISEPTICAS (BENZALKONIUM CHLORIDE) CLOTH [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.] 1 Current NDC, 2 package rows 20240515_b267e186-cf7a-458f-9c28-a48a8554af40.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 70 of 114 · 2,277 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 84219-004-00 84219000400 1 PATCH in 1 POUCH (84219-004-00) / 1 g in 1 PATCH 1 patch 2024-05-15 No No Current