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 7 of 232 · 4,636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AIBRAVEGYNECOLOGICAL INTIMATE CARE GELTupelo Brittany LLC59b64d3e-4673-a747-e063-6294a90aece92026-08-23WarningsExact identifier
unii: 85H0HZU99M
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
application number: M003
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium ChlorideBENZALKONIUM CHLORIDE TOWELETTESTrifecta Pharmaceuticals USA LLC59811e67-57f0-4db1-e063-6294a90a2ad82026-08-20WarningsExact identifier
application number: M003
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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