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 29 of 128 · 2,548 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
unii: 04JA59TNSJ
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact identifier
unii: 04JA59TNSJ
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
unii: 04JA59TNSJ
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Incfa8c154c-56c6-47de-8e43-9e012b4be95f2026-02-04WarningsExact identifier
unii: 04JA59TNSJ
0.9 percentsalineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd487cb4fc-2e0b-020f-e063-6294a90a45262026-02-03WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
unii: 04JA59TNSJ
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
Daytime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp63cb19d4-2306-4723-a95e-9d2d8b9eccd02026-02-03WarningsExact identifier
unii: 04JA59TNSJ
Nighttime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corpb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532026-02-03WarningsExact identifier
unii: 04JA59TNSJ
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc987f908b-7af7-4705-bfb4-c48d771c380d2026-02-03WarningsExact identifier
unii: 04JA59TNSJ
Allergy Relief Plus CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company38d91107-d95c-40f2-a27e-561f951e519d2026-02-02WarningsExact identifier
unii: 04JA59TNSJ
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEMethod Pharmaceuticals, LLC4bab505d-d5c8-8c3b-e063-6394a90ad18a2026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 1666372
unii: 04JA59TNSJ
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
Alveora HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4996f96a-898e-de01-e063-6394a90a39072026-01-30WarningsExact identifier
unii: 04JA59TNSJ
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 451W47IQ8X
unii: B22547B95K
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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