Home NDC 58578-0749 CloSYS
Product NDC 58578-0749
11-digit product format 585780749
Labeler code 58578
Product ID 58578-0749_4aab2169-2fe1-4d9b-94a0-45724392e6bc
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL; ORAL
Labeler Rowpar Pharmaceuticals, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-20
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58578-0749 58578-0749-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58578-0749 58578-0749-3 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 CloSYS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 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 58578-0749-1 CloSYS 1 in 1 BOX PASTE, DENTIFRICE 1 11 58578-0749-1 CloSYS 96 g in 1 TUBE PASTE, DENTIFRICE 96 11 58578-0749-2 CloSYS 1 in 1 BOX PASTE, DENTIFRICE 1 11 58578-0749-2 CloSYS 198 g in 1 TUBE PASTE, DENTIFRICE 198 11 58578-0749-3 CloSYS 21 g in 1 TUBE PASTE, DENTIFRICE 21 11 58578-0749-3 CloSYS 1 in 1 BOX PASTE, DENTIFRICE 1 11 58578-0749-4 CloSYS 198 g in 1 TUBE PASTE, DENTIFRICE 198 11 58578-0749-4 CloSYS 2 in 1 PACKAGE PASTE, DENTIFRICE 2 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58578-0749 CLOSYS (SODIUM FLUORIDE) PASTE, DENTIFRICE [ROWPAR PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 8 package rows 20250523_5f87abb7-0e9d-6369-e053-2a91aa0a2411.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 33 of 49 · 972 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 58578-0749-1 58578074901 1 TUBE in 1 BOX (58578-0749-1) / 96 g in 1 TUBE 1 tube 2017-10-20 0000-00-00 No No Current 58578-0749-2 58578074902 1 TUBE in 1 BOX (58578-0749-2) / 198 g in 1 TUBE 1 tube 2017-10-20 0000-00-00 No No Current 58578-0749-3 58578074903 1 TUBE in 1 BOX (58578-0749-3) > 21 g in 1 TUBE 1 tube 2017-10-20 0000-00-00 No No Current 58578-0749-4 58578074904 2 TUBE in 1 PACKAGE (58578-0749-4) / 198 g in 1 TUBE 2 tube 2017-10-20 No No Current