Home NDC 59448-400 Englewood Amenity
Product NDC 59448-400
11-digit product format 594480400
Labeler code 59448
Product ID 59448-400_e82aa749-3427-4411-95f4-75d74665a58d
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride and SODIUM MONOFLUOROPHOSPHATE
Dosage form KIT
Labeler ASP Global, LLc
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-13
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 Englewood Amenity
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup 2048259 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59448-002-01 Englewood Amenity 53 mL in 1 BOTTLE, PLASTIC GEL 53 mL 0.095 mg in 100mL 8 59448-400-00 Englewood Amenity 20 in 1 BOX KIT 20 8 59448-400-00 Englewood Amenity 1 in 1 BAG KIT 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59448-400 ENGLEWOOD AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC] 8 Current NDC, Legacy NDC, 3 package rows 20241222_7c9ce1bf-6aa2-4073-ad09-2ddf845102a2.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 100 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 Marketing end Sample Exclude flag Status 59448-002-01 59448000201 53 mL in 1 BOTTLE, PLASTIC 53 ml Historical 59448-400-00 59448040000 20 BAG in 1 BOX (59448-400-00) / 1 KIT in 1 BAG * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-002-01) 20 bag 2018-06-13 0000-00-00 No No Current