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 5 of 232 · 4,636 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
application number: M003
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
Povidone-Iodine Topical AntisepticPOVIDONE-IODINEMedline Industries, LPc9036a83-22f5-4a09-b01c-7093d4192c192026-08-28WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
application number: M003
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEREMEDYREPACK INC.1414bcfc-1543-4ad4-83bd-4fc444a02e922026-08-27Warnings, Adverse reactionsExact identifier
application number: NDA006488
rxcui: 1010751
rxcui: 1010755
unii: 30Q7KI53AK
unii: EC2CNF7XFP
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
application number: M003
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackf549f9ea-abc0-4fc2-b6ec-c21182eb26e62026-08-27Adverse reactionsExact identifier
unii: F446C597KA
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59ed87d5-dab1-abab-e063-6394a90a024d2026-08-26WarningsExact identifier
application number: M003
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.59f821e0-b129-5c39-e063-6294a90a47a02026-08-26WarningsExact identifier
unii: ND2M416302
Povidone Iodine SwabstickPOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLC59f82f9d-8c39-6890-e063-6294a90a090e2026-08-26WarningsExact identifier
application number: M003
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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