Home NDC 80513-608 Sodium Chloride
Product NDC 80513-608
11-digit product format 805130608
Labeler code 80513
Product ID 80513-608_38ec3c26-1c3d-5707-e063-6294a90a6a85
Type HUMAN OTC DRUG
Nonproprietary name Sodium Chloride
Dosage form TABLET
Route ORAL
Labeler Advanced Rx LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-01
Substance SODIUM CHLORIDE
Active strength 1 g/1
NDC exclude flag No
Listing certified through 2027-12-31
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 Sodium Chloride
Brand name suffix Normal Salt
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 451W47IQ8X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313009 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 80513-608-01 Sodium ChlorideNormal Salt 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80513-608 SODIUM CHLORIDE NORMAL SALT (SODIUM CHLORIDE) TABLET [ADVANCED RX LLC] 1 Current NDC, 1 package rows 20250130_40f471b7-27cf-4ad4-aef6-cc9d0623ddd9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80513-608-01 80513060801 100 TABLET in 1 BOTTLE (80513-608-01) 100 tablet 2025-01-01 No No Current