FDA.reportPublic FDA data

GENDOSE - SODIUM CHLORIDE 1 GRAM TABLETS, USP (77333-835)

Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:00

Label at a glance#

ProductSODIUM CHLORIDE 1 GRAM
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Indications and uses

FOR TTHE 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 AN ISOTONIC SOLUTION OF SODIUM CHLORIDE, DISSOLVE 1 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 CONTAINS ANY INACTIVE INGREDIENTS.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

SODIUM CHLORIDE, USP 1 GRAM

PURPOSE

OTC - PURPOSE SECTION

ELECTROLYTE REPLENISHER

USES

INDICATIONS & USAGE SECTION

  • FOR TTHE 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

  • DO NOT USE WITHOUT CONSULTING A PHYSICIAN.
  • ASK A PHYSICIAN BEFORE USE IF YOU HAVE A SODIUM RESTRICTED DIET DUE TO MULTIPLE ORGAN DISEASES.
  • STOP USE AND ASK A PHYSICIAN IF SYMPTOMS OF HEAT CRAMPS CONTIUE FOR MORE THAN 24 HOURS.
  • IF PREGNANT OR BREAST FEEDING, ASK A PHYSICIAN BEFORE USE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • TO MAKE AN ISOTONIC SOLUTION OF SODIUM CHLORIDE, DISSOLVE 1 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 INGREDIENTS

INACTIVE INGREDIENT SECTION

NONE

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 CONTAINS ANY INACTIVE INGREDIENTS.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Sodium Chloride01b LBL_Sodium Chloride

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
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77333-835-102024-05-02C16284748780-11030e365-6f5f-111a-e063-dadaa90a10e2GENDOSE - SODIUM CHLORIDE 1 GRAM TABLETS, USP (77333-835)
77333-835-102024-01-30C16284748780-11030e365-6f5f-111a-e063-dadaa90a10e2GENDOSE - SODIUM CHLORIDE 1 GRAM TABLETS, USP (77333-835)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-835-10SODIUM CHLORIDE1 GRAM100 in 1 BOXTABLET1004
77333-835-25SODIUM CHLORIDE1 GRAM1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-835SODIUM CHLORIDE 1 GRAM (SODIUM CHLORIDE) TABLET [GENDOSE PHARMACEUTICALS, LLC]4Legacy NDC, 2 package rows20240504_ee8fcda0-b1c7-fb1c-e053-2995a90af7af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-835-10EA - Each77333-835e538847d-2bd9-4c56-9469-6cfb485b5da912022-12-07
77333-835-25EA - Each77333-8356a86f719-06d3-4a3c-b1bb-3a3efde43db112022-12-07

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
77333-83577333-835-25, 77333-835-10

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
0e76213f-4e0a-ee6b-e063-6294a90a4793ee8fcda0-b1c7-fb1c-e053-2995a90af7af2024-01-08WarningsExact identifier
spl id: 0e76213f-4e0a-ee6b-e063-6294a90a4793
spl set id: ee8fcda0-b1c7-fb1c-e053-2995a90af7af

Reported adverse events (FAERS/openFDA)#

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