FDA.reportPublic FDA data

NDC 63323-751-00 - Phenylephrine Hydrochloride

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
63323-751
Requested NDC
63323-751-00
Package NDCs from labels
63323-751-05, 63323-751-10, 63323-751-00, 63323-751-01, 63323-751-03, 63323-751-13
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-10-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenylephrine Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-10-20HUMAN PRESCRIPTION DRUG LABEL
Phenylephrine Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-05-15HUMAN PRESCRIPTION DRUG LABEL
PHENYLEPHRINE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Phenylephrine Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-12-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-751-00Phenylephrine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION18
63323-751-01Phenylephrine Hydrochloride25 in 1 CARTONINJECTION258
63323-751-05Phenylephrine Hydrochloride5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION54
63323-751-05Phenylephrine Hydrochloride1 in 1 CARTONINJECTION14
63323-751-10Phenylephrine Hydrochloride10 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION104
63323-751-10Phenylephrine Hydrochloride1 in 1 CARTONINJECTION14
63323-751-03Phenylephrine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION12
63323-751-13Phenylephrine Hydrochloride25 in 1 CARTONINJECTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-751PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20231208_1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7.zip
63323-751PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 4 package rows20240125_c7026b15-1228-4acb-beed-4474fcdbb972.zip
63323-751PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]2Current NDC, Legacy NDC, 2 package rows20240110_f2dce7f1-6538-4747-9792-665eee45c0a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-751-00ML - Milliliter63323-7511394c34e-4c42-4094-b1b2-afcdc13e132b12019-07-02
63323-751-01ML - Milliliter63323-751a8b40ddc-6423-477a-9e40-f4a05b934ade12019-07-02
63323-751-03ML - Milliliter63323-751cf951bf5-4a25-4cb0-9c6b-c9e4c8cb218012020-08-06
63323-751-05ML - Milliliter63323-751321cea9d-af97-405d-9cb3-812f3c5e23d312019-07-02
63323-751-10ML - Milliliter63323-7519610d875-e8cc-4c7b-83b7-8b4ebf6a4e9e12019-07-02
63323-751-13ML - Milliliter63323-751ec8453b5-99f8-4776-90d2-3d17719905cf12020-08-06

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 43 of 126 · 2,519 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENHumphries, Inc.9af0b870-0df6-9692-e053-2995a90ac5ab2025-12-09Exact identifier
unii: N762921K75
NitrogenNITROGENQuality Air Products Inc4585b549-20cd-5d6c-e063-6294a90a949a2025-12-09Exact identifier
unii: N762921K75
NitrogenNITROGENWEST PENN LACO, INC.bd201f32-444c-304d-e053-2a95a90ad9402025-12-09Exact identifier
unii: N762921K75
NitrogenNITROGENTIMS SOUTH TEXAS LLC290395e3-cdf4-4286-e063-6394a90a782f2025-12-09Exact identifier
unii: N762921K75
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Daytime Cold and Flu Relief, 24-7 Life BY 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.2771d699-3f70-4318-e063-6394a90a89cc2025-12-09WarningsExact identifier
unii: 04JA59TNSJ
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC30d41dc3-e2ef-4cad-b63c-d634bc749aa12025-12-09WarningsExact identifier
unii: 04JA59TNSJ
dg health cold plus flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCff4a2f0a-d638-4ed2-8e05-2a52afbc49092025-12-09WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)24894484-b834-4b2f-b365-c95b5e30d8bf2025-12-09WarningsExact identifier
unii: 04JA59TNSJ
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESOLA Pharmaceuticals, LLCbf264b20-6d00-495e-90c7-9172d4535ec72025-12-08Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
NitrogenNITROGENGas and Supply Carolinas, LLC05a6f3ad-c96a-4345-e063-6294a90a8b7a2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.50df5a35-754d-423f-885c-ade8652596162025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENIndustrial Welding & Tool Supply, Ltd.cee001dd-54ed-4824-aa22-955c791844df2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENIWS Gas and Supply of Texas, LTDbfe95982-1606-4878-95b0-5d3bc662cc2c2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENABSOLUTE AIR LLCe1e64a61-d0e8-0f8e-e053-2a95a90af1862025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENSouthern Gas & Supply LLC9f5822ee-0117-4e37-a9c6-555cf5835e9b2025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENSOUTHERN GAS AND SUPPLY, INC.d6a75eea-7f96-2a42-e053-2995a90a72132025-12-08Exact identifier
unii: N762921K75
NitrogenNITROGENSOUTHERN GAS AND SUPPLY, INC. dba Gas and Supply9af0511f-2898-d928-e053-2a95a90a75882025-12-08Exact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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