FDA.reportPublic FDA data

Sodium Chloride

Product NDC
70369-010
11-digit product format
703690010
Labeler code
70369
Product ID
70369-010_2ce80e1e-5259-596d-e063-6294a90add01
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Citragen Pharmaceuticals Inc
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-20
Substance
SODIUM CHLORIDE
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70369-010-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70369-010-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70369-010-090efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Chloride
Brand name suffix
Normal Salt
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
451W47IQ8XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2387545Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aae783b2-18fe-69ca-e053-2a95a90a0800Available on FDA.report

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
70369-010-092025-02-01C16284748780-12cef2736-7a92-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70369-010-09Sodium ChlorideNormal Salt200 in 1 BOTTLETABLET2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70369-010SODIUM CHLORIDE NORMAL SALT (SODIUM CHLORIDE) TABLET [CITRAGEN PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 1 package rows20250131_aae783b2-18fe-69ca-e053-2a95a90a0800.zip

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 4 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
application number: M018
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
application number: M018
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
application number: M018
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
application number: M018
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
application number: M018
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
application number: M018
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
application number: M018
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
application number: M018
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
application number: M018
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
application number: M018
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
application number: M018
NOVEHA NIGHTTIMEWHITE PETROLATUMBullet Point LLC4da24578-e98b-8ce1-e063-6294a90a8bf62026-03-24WarningsExact identifier
application number: M018
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
application number: M018
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
application number: M018
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
application number: M018
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387545sodium chloride 500 MG Oral TabletPSNaae783b2-18fe-69ca-e053-2a95a90a08003
2387545sodium chloride 500 MG Oral TabletSCDaae783b2-18fe-69ca-e053-2a95a90a08003
2387545NaCl 500 MG Oral TabletSYaae783b2-18fe-69ca-e053-2a95a90a08003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70369-010-0970369001009200 TABLET in 1 BOTTLE (70369-010-09) 200 tablet2020-07-200000-00-00NoNoCurrent