FDA.reportPublic FDA data

Sodium Chloride Tablets, USP

Manufacturer
Advanced Rx LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:21

Label at a glance#

ProductSodium Chloride Normal Salt
Active ingredientSODIUM CHLORIDE
Label structure10 sections

Indications and uses

for the preparation of normal isotonic solution of sodium chloride as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration any alternative use as directed by a physician

Dosage and administration

to make isontonic solution of sodium chloride, dissolve one tablet in 120 ml (four ounces) of distilled water and use as directed by a physician. if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by your physician.

Storage and handling

each tablet contains: sodium 394 mg store at room temperature 15°-30°C (59°-86°F) product does not contain any inactive ingredients DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS MISSING OR DAMAGED

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sodium Chloride, USP 1.0 Gram

Purpose

OTC - PURPOSE SECTION

Electrolyte Replenisher

Uses

INDICATIONS & USAGE SECTION

  • for the preparation of normal isotonic solution of sodium chloride
  • as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration
  • any alternative use as directed by a physician

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not usewithout consulting a physician

OTC - ASK DOCTOR SECTION

Ask a physician before use if you havea sodium restricted diet due to multiple organ diseases

OTC - STOP USE SECTION

Stop use and ask a physician ifsymptoms of heat cramps continue for more than 24 hours.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • to make isontonic solution of sodium chloride, dissolve one tablet in 120 ml (four ounces) of distilled water and use as directed by a physician.
  • if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by your physician.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:sodium 394 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • product does not contain any inactive ingredients
  • DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS MISSING OR DAMAGED

INACTIVE INGREDIENT SECTION

None

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-630-8895

SPL UNCLASSIFIED SECTION

Manufactured for:

Advanced Rx LLC

1942 NE 163rd St.

North Miami Beach,

FL 33162 U.S.A.

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80513-608-01

Sodium Chloride Tablets, USP 1 Gram

Normal Salt Tablets

For solution or oral use

100 Tablets

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313009sodium chloride 1 GM Oral TabletPSN2
313009sodium chloride 1000 MG Oral TabletSCD2
313009NaCl 1000 MG Oral TabletSY2
313009sodium chloride 0.124 MEQ/ML Oral SolutionSY2
313009sodium chloride 0.171 MEQ/ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-608-01Sodium ChlorideNormal Salt100 in 1 BOTTLETABLET1002

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-60880513-608-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Chloride Normal SaltSODIUM CHLORIDEAdvanced Rx LLC40f471b7-27cf-4ad4-aef6-cc9d0623ddd92025-07-02WarningsExact identifier
ndc (package): 80513-608-01
ndc (product): 80513-608
ndc11 (package): 80513060801
spl id: 38ec3c26-1c3d-5707-e063-6294a90a6a85
spl set id: 40f471b7-27cf-4ad4-aef6-cc9d0623ddd9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.