FDA.reportPublic FDA data

NDC 63323-965-01 - Potassium 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
63323-965
Requested NDC
63323-965-01
Package NDCs from labels
63323-965-01, 63323-965-05, 63323-965-03, 63323-965-10, 63323-965-02, 63323-965-20
Manufacturer
Henry Schein, Inc.
Effective date
2025-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE, USPHenry Schein, Inc.2025-08-12HUMAN PRESCRIPTION DRUG LABEL
Potassium Chloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-02-27HUMAN PRESCRIPTION DRUG LABEL
Potassium Chloride - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-29HUMAN PRESCRIPTION DRUG LABEL
POTASSIUM CHLORIDE - General Injectables & Vaccines, Inc.General Injectables & Vaccines, Inc.2022-12-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-965-01Potassium Chloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE55
63323-965-02Potassium Chloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE205
63323-965-03Potassium Chloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE105
63323-965-05Potassium Chloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE255
63323-965-10Potassium Chloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE255
63323-965-20Potassium Chloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-965POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 6 package rows20230316_fcd4f458-ce27-417e-9bb6-de1cc49d44b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-965-01ML - Milliliter63323-9651bbfa031-5c7d-4660-bfc1-4d4f0c7b404912019-10-07
63323-965-02ML - Milliliter63323-965eb59be88-d60b-48d6-ae5b-4790007c02c512019-09-05
63323-965-03ML - Milliliter63323-965f645fe1e-bd3d-4cdc-99db-7744f42ecbab12019-10-07
63323-965-05ML - Milliliter63323-9651908bab0-016a-48b3-93bc-249396e92c0712012-07-24
63323-965-10ML - Milliliter63323-9658be2fd64-e5a7-4231-b851-2399e724fac712012-07-24
63323-965-20ML - Milliliter63323-965346766e4-da06-4c17-94c3-4ef8fe05b96e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium ChlorideACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
Potassium CationACTIVE MOIETY295O53K152POTASSIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPOTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [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 34 · 672 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: 660YQ98I10
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: 660YQ98I10
hearingAESCULUS HIPPOCASTANUM, FLOS, CALC SULP, CALLUNA VULGARIS, FLOS, CLEMATIS VITALBA, FLOS, FER PHOS, KALI MUR, KALI SULPHSiddha Flower Essences LLCa239fd77-2687-45ad-a7c7-e9ffa15a635a2025-12-31WarningsExact identifier
unii: 660YQ98I10
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
unii: 660YQ98I10
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC471f3a39-5fea-cd7a-e063-6294a90a0d932025-12-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONAjenat Pharmaceuticals LLCc62c5704-3667-4d4f-8230-3f7f5ed825b12025-12-29Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLC0a72cc27-e092-d85a-e063-6294a90a503c2025-12-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBPI Labs LLCaeb2e14e-cd7c-49d0-a15f-fbbe89a03c6b2025-12-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
potassium chloridePOTASSIUM CHLORIDERedpharm Drug3735d41a-7787-6b92-e063-6294a90add452025-12-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC0700c19e-abca-4527-8944-e4440a32e3af2025-12-18Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Pediatric Earache RemedyEAR DROPSVitality Works, Inc5769ce2c-d2e1-4069-92cc-e38bee668daf2025-12-17WarningsExact identifier
unii: 660YQ98I10
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 660YQ98I10
Earache RemedyEAR DROPSVitality Works, Inc.49afb2c3-ee42-4be9-943a-36d73ded00042025-12-17WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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