Home NDC 58578-0759 CloSYS
Product NDC 58578-0759
11-digit product format 585780759
Labeler code 58578
Product ID 58578-0759_ea159a8d-4d2b-49ec-b6e6-f088312c0117
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler Rowpar Pharmaceuticals, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-06
Substance SODIUM FLUORIDE
Active strength .916 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 .916 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 1099038 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 58578-0759-1 CloSYS 1 in 1 BOX PASTE, DENTIFRICE 1 7 58578-0759-1 CloSYS 96 g in 1 TUBE PASTE, DENTIFRICE 96 7 58578-0759-2 CloSYS 21 g in 1 TUBE PASTE, DENTIFRICE 21 7 58578-0759-2 CloSYS 1 in 1 BOX PASTE, DENTIFRICE 1 7 58578-0759-3 CloSYS 2 in 1 PACKAGE PASTE, DENTIFRICE 2 7 58578-0759-3 CloSYS 96 g in 1 TUBE PASTE, DENTIFRICE 96 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58578-0759 CLOSYS (SODIUM FLUORIDE) PASTE, DENTIFRICE [ROWPAR PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 6 package rows 20250523_ed617c7a-805c-4788-9bce-9b7fead4312d.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 4 of 50 · 995 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 58578-0759-1 58578075901 1 TUBE in 1 BOX (58578-0759-1) / 96 g in 1 TUBE 1 tube 2020-01-06 0000-00-00 No No Current 58578-0759-2 58578075902 1 TUBE in 1 BOX (58578-0759-2) > 21 g in 1 TUBE 1 tube 2020-01-06 0000-00-00 No No Current 58578-0759-3 58578075903 2 TUBE in 1 PACKAGE (58578-0759-3) / 96 g in 1 TUBE 2 tube 2020-01-06 No No Current