Home NDC 75826-165 Fluoride
Product NDC 75826-165
11-digit product format 758260165
Labeler code 75826
Product ID 75826-165_47a68277-53e0-538f-e063-6394a90aa82c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler WINDER LABORATORIES, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-01-01
Substance SODIUM FLUORIDE
Active strength 1 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Fluoride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198215 Internal RxNorm lookup 313036 Internal RxNorm lookup 315213 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 75826-165-20 Fluoride 120 in 1 BOTTLE TABLET, CHEWABLE 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75826-165 FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [WINDER LABORATORIES, LLC] 1 Current NDC, 1 package rows 20240103_0df8f1aa-f3ef-9f59-e063-6294a90a0666.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluoride SODIUM FLUORIDE WINDER LABORATORIES, LLC 0df8f1aa-f3ef-9f59-e063-6294a90a0666 2026-01-05 Warnings, Adverse reactions Exact identifier ndc (product): 75826-165
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 75826-165-20 75826016520 120 TABLET, CHEWABLE in 1 BOTTLE (75826-165-20) 2024-01-01 No No Current