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 7 of 131 · 2,620 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLC1767c4b7-36a0-4e64-9091-2af22161402f2026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
unii: 04JA59TNSJ
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLCf43e4abd-0083-4fe5-9c27-0ba9245e51382026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
unii: 04JA59TNSJ
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
unii: 04JA59TNSJ
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
unii: 04JA59TNSJ
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
unii: 04JA59TNSJ
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
unii: 04JA59TNSJ
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
unii: 04JA59TNSJ
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
unii: 04JA59TNSJ
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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