Home NDC 63621-354-85 SunDrops 77
Product NDC 63621-354
Requested package NDC 63621-354-85
11-digit product format 636210354
Labeler code 63621
Product ID 63621-354_43535ccc-3e06-c1e0-e063-6294a90a3acb
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SOAP
Route TOPICAL
Labeler Sunburst Chemicals, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-05-05
Substance BENZALKONIUM CHLORIDE
Active strength 1 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 SunDrops 77
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Benzalkonium Chloride ACTIVE INGREDIENT F5UM2KM3W7 SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2 Benzalkonium ACTIVE MOIETY 7N6JUD5X6Y SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2 CETRIMONIUM CHLORIDE INACTIVE INGREDIENT UC9PE95IBP SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2 DIHYDROXYETHYL COCAMINE OXIDE INACTIVE INGREDIENT 8AR51R3BL5 SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2 GLYCERETH-17 COCOATE INACTIVE INGREDIENT 3057VPT0KC SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2 LAURTRIMONIUM CHLORIDE INACTIVE INGREDIENT A81MSI0FIC SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63621-354 SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.] 8 Current NDC, Legacy NDC, 6 package rows 20241017_fc0ba65c-5307-4251-a60b-cde84ad56ad8.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63621-354-85 63621035485 8 BAG in 1 BOX (63621-354-85) / 1000 mL in 1 BAG 8 bag 2012-09-28 0000-00-00 No No Current