FDA.reportPublic FDA data

NDC 63323-186-01 - Sodium Chloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63323-186
Requested NDC
63323-186-01
Package NDCs from labels
63323-186-00, 63323-186-04, 63323-186-02, 63323-186-01, 63323-186-10, 63323-186-03, 63323-186-20
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sodium Chloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-11-28HUMAN PRESCRIPTION DRUG LABEL
Sodium Chloride - Cardinal Health 107, LLCCardinal Health 107, LLC2025-10-29HUMAN PRESCRIPTION DRUG LABEL
45764F/Revised: November 2020 SODIUM CHLORIDE INJECTION, USP 0.9%Henry Schein, Inc.2025-08-07HUMAN PRESCRIPTION DRUG LABEL
Sodium Chloride - A-S Medication SolutionsA-S Medication Solutions2023-12-10HUMAN PRESCRIPTION DRUG LABEL
45764D/Revised: January 2008 SODIUM CHLORIDE INJECTION, USP 0.9%General Injectables and Vaccines, Inc.2022-12-28HUMAN PRESCRIPTION DRUG LABEL
Sodium Chloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-02-10HUMAN PRESCRIPTION DRUG LABEL
P-Care XRX PHARMA-PACK, INC.2020-02-03HUMAN PRESCRIPTION DRUG LABEL
P-Care MGRX PHARMA-PACK, INC.2020-02-03HUMAN PRESCRIPTION DRUG LABEL
P-Care K80MXRX PHARMA-PACK, INC.2020-02-03HUMAN PRESCRIPTION DRUG LABEL
P-Care K40MXRX PHARMA-PACK, INC.2020-02-03HUMAN PRESCRIPTION DRUG LABEL
P-Care MRX PHARMA-PACK, INC.2020-02-03HUMAN PRESCRIPTION DRUG LABEL
P-Care D40MXRX PHARMA-PACK, INC.2020-01-31HUMAN PRESCRIPTION DRUG LABEL
P-Care 100MXRX PHARMA-PACK, INC.2020-01-31HUMAN PRESCRIPTION DRUG LABEL
Sodium Chloride Injection, USPREMEDYREPACK INC.2018-09-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-186-01Sodium Chloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION109
63323-186-02Sodium Chloride25 in 1 TRAYINJECTION259
63323-186-03Sodium Chloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION209
63323-186-04Sodium Chloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION29
63323-186-10Sodium Chloride25 in 1 TRAYINJECTION259
63323-186-20Sodium Chloride25 in 1 TRAYINJECTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-186SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 6 package rows20220215_f62481fd-fcdb-4be6-ac13-29c590e925c3.zip
63323-186SODIUM CHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC20241017_f2a98378-9678-4738-9670-fc7a215c0606.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-186-00ML - Milliliter63323-186631ef22b-45f3-4475-ac41-b8c42c80816612013-02-13
63323-186-01ML - Milliliter63323-186ad4d7cee-1556-46ad-804d-561c65beb25912019-11-12
63323-186-02ML - Milliliter63323-186a03cf0f1-7038-4766-bb04-a68590379e2c12013-02-13
63323-186-03ML - Milliliter63323-1862c9b6e64-5c28-473e-b4da-26594477ceaf12020-05-08
63323-186-10ML - Milliliter63323-186ef27364f-084d-489c-b30a-18d183641cd312016-04-04
63323-186-20ML - Milliliter63323-1864f06c3c9-0753-4b0e-8d0a-075b0d9169cd12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1

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 3 of 232 · 4,636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
application number: M003
Triamcinolone acetonideTRIAMCINOLONE ACETONIDERedpharm Drug5a79639b-eb66-e726-e063-6394a90aeb012026-09-02Adverse reactionsExact identifier
unii: F446C597KA
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Hydrogen PeroxideHYDROGEN PEROXIDEUpLift Brands, LLC5a81b635-d188-0b29-e063-6294a90a1e4b2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECVS Pharmacy, Inc.7f518646-c8fe-499a-b5e4-8e5a5a90e01d2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
application number: M003
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-09-02WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsExact identifier
unii: 85H0HZU99M
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1986c302-82a0-95a9-e063-6294a90a33392026-09-02Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1737343
rxcui: 1737345
unii: EC2CNF7XFP
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
application number: M003
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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