FDA.reportPublic FDA data

Sodium Chloride Tablets, USP

Manufacturer
TWIN MED LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:52:10

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 392 mg store at room temperature 15°-30°C (59°-86°F) product does not contain any inactive ingredients DO NOT USE IF PRINTED 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 use without 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 if symptoms 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

Inactive ingredient

INACTIVE INGREDIENT SECTION

None

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 392 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • product does not contain any inactive ingredients
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-844-912-4012

SPL UNCLASSIFIED SECTION

Manufactured for:

TwinMed LLC.

11333 Greenstone Ave

Santa Fe Springs, CA 90670

ProCureProducts.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313009sodium chloride 1 GM Oral TabletPSN3
313009sodium chloride 1000 MG Oral TabletSCD3
313009NaCl 1000 MG Oral TabletSY3
313009sodium chloride 0.124 MEQ/ML Oral SolutionSY3
313009sodium chloride 0.171 MEQ/ML Oral SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-333-02Sodium ChlorideNormal Salt200 in 1 BOTTLETABLET2003

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
55681-33355681-333-02

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 CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
ndc (package): 55681-333-02
ndc (product): 55681-333
ndc11 (package): 55681033302
spl id: 4e507f5a-9254-a674-e063-6394a90aceb7
spl set id: 10230c8a-e5e5-44f1-b41d-80930899d6b9

Reported adverse events (FAERS/openFDA)#

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