FDA.reportPublic FDA data

Sodium Chloride

Manufacturer
Vin Trading LLC | Shijiazhuang No 4 Parmaceutical CO Ltd. | Shijiazhuang No 4 Pharmaceutical CO Ltd
Effective date
2024-12-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 21:20:36

Label at a glance#

ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure4 sections

Storage and handling

Sterile, nonpyrogenic, Single unit container. Discard unused portion. Recommended storage. Store at 20-25*C (66-77*F) Avoid excessive heat. Protect from freezing

Label contents#

Full prescribing information#

COMPONENTS

1000ml

SODIUM CHLORIDE 0.9%

Isotonic Solution for Infusion UPS

Sterile, nonpyrogenic, Single unit container. Discard unused portion.

Recommended storage. Store at 20-25*C (66-77*F)

Avoid excessive heat. Protect from freezing

Composition:

Each 100ml contains...0.9% (m/v-w/v)

Water for Injection..........................q.s.

Electrolytes (mEq/liter)

Na+ 150 CI 150

USER SAFETY WARNINGS SECTION

Caution:

FOR INTRAVENOUS INFUSION ONLY

Not to be used if container is found leaking or solution is not clear.

Solution containing visible solid particles should not be used.

Any portion of the contents remaining should be discarded.

For use under medical supervision.

STORAGE AND HANDLING SECTION

Sterile, nonpyrogenic, Single unit container. Discard unused portion.

Recommended storage. Store at 20-25*C (66-77*F)

Avoid excessive heat. Protect from freezing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton.jpgCarton.jpg

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
85036-100-022024-12-16C16284748780-1291dabf8-663e-e8b1-e063-dbdaa90a514928ef1c8f-cb2f-626f-e063-6294a90a6db8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85036-100-04Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10003
85036-100-05Sodium Chloride12 in 1 CARTONINJECTION, SOLUTION123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85036-100SODIUM CHLORIDE (SODIUM CHLORIDE INJECTION) INJECTION, SOLUTION [VIN TRADING LLC]32 package rows20241228_28ef1c8f-cb2f-626f-e063-6294a90a6db8.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
85036-10085036-100-04, 85036-100-05

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
2a3d8a77-44ff-9958-e063-6394a90a132528ef1c8f-cb2f-626f-e063-6294a90a6db82024-12-27Exact identifier
spl id: 2a3d8a77-44ff-9958-e063-6394a90a1325
spl set id: 28ef1c8f-cb2f-626f-e063-6294a90a6db8

Reported adverse events (FAERS/openFDA)#

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