Home NDC 59448-800 Wellstar Amenity
Product NDC 59448-800
11-digit product format 594480800
Labeler code 59448
Product ID 59448-800_961c53ef-0590-4aa8-8cef-667615bd0c4b
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 2021-10-01
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 Wellstar 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 581660 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 59448-008-01 Wellstar Amenity 53 mL in 1 BOTTLE, PLASTIC GEL 53 mL 62 mL in 100mL 4 59448-800-00 Wellstar Amenity 20 in 1 BOX KIT 20 4 59448-800-00 Wellstar Amenity 1 in 1 BAG KIT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59448-800 WELLSTAR AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ) KIT [ASP GLOBAL, LLC] 4 Current NDC, Legacy NDC, 3 package rows 20241222_ced9dd96-7922-43d7-906f-32afaad733ec.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 106 of 115 · 2,286 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 59448-008-01 59448000801 53 mL in 1 BOTTLE, PLASTIC 53 ml Historical 59448-800-00 59448080000 20 BAG in 1 BOX (59448-800-00) / 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 (59448-008-01) 20 bag 2021-10-01 0000-00-00 No No Current