FDA.reportPublic FDA data

SODIUM CHLORIDE TABLETS, USP 1 Gram (15.4 gr.)

Manufacturer
Kesin Pharma Corporation
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:14

Label at a glance#

ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Directions to make isotonic 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.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sodium Chloride, USP 1 Gram

Purpose

OTC - PURPOSE SECTION

Electrolyte Replenisher

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

Do not use without consulting a physician

Ask a physician before use

OTC - ASK DOCTOR SECTION

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

Stop use and ask a physician

OTC - STOP USE SECTION

Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours

If pregnant or breast-feeding

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

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • to make isotonic 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

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: sodium 394 mg
  • store at room temperature 15ºC to 30ºC (59ºF to 86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • product does not contain any inactive ingredients

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Rev 02/2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Chloride Tablets, USP

1 Gram (15.4 gr.)

Normal salt tablets

For solution or oral use

100 Tablets

Sodium Chloride Tablets 1 Gram 100 Ct Bottle LabelSodium Chloride Tablets 1 Gram 100 Ct Bottle Label

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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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-028-01Sodium Chloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-028-01EA - Each81033-028fe4840e0-706e-4ecb-a47b-86117080f66212025-05-14

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
81033-02881033-028-01

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 ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
ndc (package): 81033-028-01
ndc (product): 81033-028
ndc11 (package): 81033002801
spl id: 43cf75a9-e660-c580-e063-6394a90a0b87
spl set id: 2f107592-10c5-ef3b-e063-6394a90a7c0a

Reported adverse events (FAERS/openFDA)#

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