NDC 0641-6142-01 - 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
0641-6142
Requested NDC
0641-6142-01
Package NDCs from labels
0641-6142-01, 0641-6142-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2026-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenylephrine Hydrochloride - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2026-08-19HUMAN PRESCRIPTION DRUG LABEL
PHENYLEPHRINE HCI - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Phenylephrine Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-30HUMAN PRESCRIPTION DRUG LABEL
Phenylephrine Hydrochloride - Cardinal HealthCardinal Health2020-06-12HUMAN PRESCRIPTION DRUG LABEL
PHENYLEPHRINE HYDROCHLORIDE - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2019-12-31HUMAN PRESCRIPTION DRUG LABEL
Phenylephrine Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2018-03-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6142-01Phenylephrine Hydrochloride1 mL in 1 VIALINJECTION112
0641-6142-25Phenylephrine Hydrochloride25 in 1 CARTONINJECTION2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6142PHENYLEPHRINE HYDROCHLORIDE INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTABLE, LIPOSOMAL [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20240410_e1a7ab4b-0afe-4463-a039-5be0323cf2f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6142-01ML - Milliliter0641-61422163e7a3-7bd4-48f6-8efb-d3b2a136e89e12013-03-03
0641-6142-25ML - Milliliter0641-614268bfdb02-41e9-4ce8-9c3f-7d4c4b6b5f5512013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
WATERINACTIVE INGREDIENT059QF0KO0RPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RPHENYLEPHRINE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES & VACCINES, INC]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 59 of 125 · 2,491 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BedwettingECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUSNewton Laboratories, Inc.9d5f51d0-01e9-271c-e053-2995a90a63bc2025-07-24WarningsExact identifier
unii: 451W47IQ8X
BedwettingECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUSNewton Laboratories, Inc.9d6058a0-69dd-66d0-e053-2a95a90a58f82025-07-24WarningsExact identifier
unii: 451W47IQ8X
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: 451W47IQ8X
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: 451W47IQ8X
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
unii: 04JA59TNSJ
Dr Butlers Advanced Hemorrhoid ReliefLIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%Beyond Health. PA3aa0ee7a-3863-254d-e063-6394a90ad40e2025-07-23WarningsExact identifier
unii: 04JA59TNSJ
Sodium ChlorideSODIUM CHLORIDENextgen Pharmaceuticals LLC28f79c75-82d2-4912-81fc-a723b5ccf4c12025-07-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
unii: 04JA59TNSJ
Dr. Butler Hemorrhoid TreatmentPHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%Beyond Health P.A.d2d1c81c-6443-c4b7-e053-2995a90a14d72025-07-22WarningsExact identifier
unii: 04JA59TNSJ
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
unii: 04JA59TNSJ
ADVIL SINUS CONGESTION AND PAINIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf2025-07-22WarningsExact identifier
unii: 04JA59TNSJ
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
unii: 04JA59TNSJ
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
unii: 04JA59TNSJ
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: 04JA59TNSJ
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEProPharma Distribution3868864f-4f46-d2a1-e063-6394a90a65d52025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: 451W47IQ8X
up and up nighttime flu and severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationdf488727-b913-440b-9a0b-cce3ae143bf22025-07-15WarningsExact identifier
unii: 04JA59TNSJ
Good Sense HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLL. Perrigo Company379f8738-a871-4b09-abd1-c86386dfee042025-07-15WarningsExact identifier
unii: 04JA59TNSJ
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: 04JA59TNSJ
ReVIVOL-XRPHENYLEPHRINE HYDROCHLORIDEUnipack LLC2950fe83-a2a4-4ed4-b645-69d6fd2381ae2025-07-13WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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