FDA.reportPublic FDA data

Sodium Chloride Tablets, USP

Manufacturer
Citragen Pharmaceuticals Inc
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:04

Label at a glance#

ProductSodium Chloride Normal Salt
Active ingredientSODIUM CHLORIDE
Label structure11 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

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 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 children.

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 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

Questions or comments?

OTC - QUESTIONS SECTION

Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: info@citragenpharma.com

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.

www.citragenpharma.com

Rev. 02/19 R-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369‐007‐02

Sodium Chloride Tablets, USP 1 gram

Normal salt tablets

For solution or oral use
500 Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

500's Bottle Label500's Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369‐007‐03

Sodium Chloride Tablets, USP 1 gram

Normal salt tablets

For solution or oral use
100 Tablets

100's Bottle Label100's Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369‐007‐07

Sodium Chloride Tablets, USP 1 gram

Normal salt tablets

For solution or oral use
300 Tablets

300s Pack Label300s Pack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313009sodium chloride 1 GM Oral TabletPSN4
313009sodium chloride 1000 MG Oral TabletSCD4
313009NaCl 1000 MG Oral TabletSY4
313009sodium chloride 0.124 MEQ/ML Oral SolutionSY4
313009sodium chloride 0.171 MEQ/ML Oral SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70369-007-022025-02-01C16284748780-12cef2736-6402-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP
70369-007-032025-02-01C16284748780-12cef2736-6402-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP
70369-007-072025-02-01C16284748780-12cef2736-6402-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP
70369-007-022025-01-30C16284748780-12cef2736-6402-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP
70369-007-032025-01-30C16284748780-12cef2736-6402-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP
70369-007-072025-01-30C16284748780-12cef2736-6402-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70369-007-02Sodium ChlorideNormal Salt500 in 1 BOTTLETABLET5004
70369-007-03Sodium ChlorideNormal Salt100 in 1 BOTTLETABLET1004
70369-007-07Sodium ChlorideNormal Salt300 in 1 BOTTLETABLET3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70369-007SODIUM CHLORIDE NORMAL SALT (SODIUM CHLORIDE) TABLET [CITRAGEN PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 3 package rows20250131_82c29f1d-a018-7483-e053-2a91aa0a8f7e.zip

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
70369-00770369-007-02, 70369-007-03, 70369-007-07

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 CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
ndc (package): 70369-007-07
ndc (package): 70369-007-03
ndc (package): 70369-007-02
ndc (product): 70369-007
ndc11 (package): 70369000703
ndc11 (package): 70369000707
ndc11 (package): 70369000702
spl id: 2ce83af4-bf51-bf5f-e063-6294a90ae962
spl set id: 82c29f1d-a018-7483-e053-2a91aa0a8f7e

Reported adverse events (FAERS/openFDA)#

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