Home NDC 59448-213 Northside Hospital Grey Amenity Kit
Product NDC 59448-213
11-digit product format 594480213
Labeler code 59448
Product ID 59448-213_8c309db8-d099-4f8c-bdf6-1c3328dc4746
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophospate
Dosage form KIT
Labeler ASP Global, LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-01
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 Northside Hospital Grey Amenity Kit
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 581662 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 59448-011-01 Northside Hospital Grey Amenity Kit 53 mL in 1 BOTTLE, PLASTIC GEL 53 mL 70 mL in 100mL 1 59448-213-00 Northside Hospital Grey Amenity Kit 1 in 1 KIT KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59448-213 NORTHSIDE HOSPITAL GREY AMENITY KIT (SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC] 1 Current NDC, 2 package rows 20250426_a3cc89df-be1b-4d9a-8ba3-857885325422.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 92 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 Sample Exclude flag Status 59448-011-01 59448001101 53 mL in 1 BOTTLE, PLASTIC 53 ml Historical 59448-213-00 59448021300 1 KIT in 1 KIT (59448-213-00) * 10 g in 1 TUBE (84132-100-10) * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 53 mL in 1 BOTTLE, PLASTIC (59448-011-01) * 60 mL in 1 BOTTLE, PLASTIC 1 kit 2025-04-01 No No Current