Home NDC 58578-1234 CloSYS
Product NDC 58578-1234
11-digit product format 585781234
Labeler code 58578
Product ID 58578-1234_42ecdcc7-82b3-49f6-bff8-0b38c247433e
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form RINSE
Route ORAL
Labeler Rowpar Pharmaceuticals, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-02-18
Substance SODIUM FLUORIDE
Active strength .05 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 58578-1234 58578-1234-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58578-1234 58578-1234-2 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
Brand name suffix Fluoride Rinse
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .05 g/100mL
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 240698 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 58578-1234-1 CloSYSFluoride Rinse 1 in 1 BOX RINSE 1 8 58578-1234-1 CloSYSFluoride Rinse 473 mL in 1 BOTTLE RINSE 473 8 58578-1234-2 CloSYSFluoride Rinse 100 mL in 1 BOTTLE RINSE 100 8 58578-1234-2 CloSYSFluoride Rinse 100 mL in 1 BOTTLE RINSE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58578-1234 CLOSYS FLUORIDE RINSE (SODIUM FLUORIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20241225_1a994f24-99ee-4b27-aab0-e816931a22c8.zip 58578-1234 CLOSYS FLUORIDE RINSE (SODIUM FLUORIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20160221_e164f877-3163-4c16-afae-ff83efb079d9.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 58578-1234-1 58578123401 1 BOTTLE in 1 BOX (58578-1234-1) > 473 mL in 1 BOTTLE 1 bottle 2016-02-18 0000-00-00 No No Current 58578-1234-2 58578123402 100 mL in 1 BOTTLE (58578-1234-2) 100 ml 2016-02-18 0000-00-00 No No Current