Home NDC 75712-897-03 Antibacterial
Product NDC 75712-897
Requested package NDC 75712-897-03
11-digit product format 757120897
Labeler code 75712
Product ID 75712-897_4c1088b2-e7a4-ff3a-e063-6394a90a5b3e
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride
Dosage form SOAP
Route TOPICAL
Labeler Old East Main Co.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-03
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 Antibacterial
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
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 1046593 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 75712-897-03 Antibacterial 1478 mL in 1 BOTTLE, PLASTIC SOAP 1478 3 75712-897-96 Antibacterial 221 mL in 1 BOTTLE, PLASTIC SOAP 221 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75712-897 ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOAP [OLD EAST MAIN CO.] 1 Current NDC, 2 package rows 20241206_3effae93-fd00-4aac-a42f-b5b67123f851.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 1 of 1 · 1 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 75712-897-03 75712089703 1478 mL in 1 BOTTLE, PLASTIC (75712-897-03) 1478 ml 2024-12-03 No No Current