FDA.reportPublic FDA data

Sodium Chloride - Method Pharmaceuticals, LLC

Manufacturer
Method Pharmaceuticals, LLC
Effective date
2026-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:54:49

Label at a glance#

ProductSodium Chloride
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 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

NONE

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 have a 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 Chlidren

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

  • each tablet contains: sodium 394 mg
  • store at room temperature 15ºC to 30ºC (59ºF to 86ºF)
  • Product does not contain any inactive ingredients
  • Supplied as round white tablet imprinted with "M119"

OTC - QUESTIONS SECTION

Questions or comments?1-877-250-3427

SPL UNCLASSIFIED SECTION

Rev. 09/25

Manufactured in the U.S.A. for

Method Pharmaceuticals, LLC

Southlake, Texas 76092

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC-58657-119-01

Sodium Chloride Tablets, USP

1 gram

Normal salt tablets

For solutins 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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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-119-01Sodium Chloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-119-01EA - Each58657-1191b20513e-4fc4-4e4e-bbf7-565d6ce7cdd712026-04-20

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58657-11958657-119-01

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-17monthly-update2026-06-03 17:56:38

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 CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
ndc (package): 58657-119-01
ndc (product): 58657-119
ndc11 (package): 58657011901
spl id: 50266e4c-32ea-0583-e063-6294a90a6ff4
spl set id: 4b08859e-65bd-8255-e063-6394a90af614

Reported adverse events (FAERS/openFDA)#

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