Home NDC 61554-315 Claravie
Product NDC 61554-315
11-digit product format 615540315
Labeler code 61554
Product ID 61554-315_59887af3-9b23-9664-e063-6294a90a57c6
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form LOTION
Route TOPICAL
Labeler Gentell LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-21
Substance BENZALKONIUM CHLORIDE
Active strength .1 g/100mL
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 Claravie
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .1 g/100mL
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 1233282 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 9 of 115 · 2,286 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61554-315-41 61554031541 237 mL in 1 BOTTLE (61554-315-41) 237 ml 2026-08-21 No No Current