FDA.reportPublic FDA data

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 78 of 122 · 2,424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC624b8029-9fdb-4908-a13b-f9dd750301202024-11-11WarningsExact identifier
unii: 04JA59TNSJ
foster and thrive nighttime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC298b7754-d0d8-496d-9949-4c346cb11e342024-11-11WarningsExact identifier
unii: 04JA59TNSJ
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
unii: 04JA59TNSJ
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
unii: 04JA59TNSJ
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
unii: 04JA59TNSJ
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
unii: 04JA59TNSJ
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
unii: 04JA59TNSJ
SUDAFED PE Head Congestion Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC1e528f78-0ced-4a06-935a-84056c9217272024-11-08WarningsExact identifier
unii: 04JA59TNSJ
Childrens Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCb8b75904-3806-4258-89c1-d6ff486ed41c2024-11-08WarningsExact identifier
unii: 04JA59TNSJ
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
McKesson Phenylephrine HClPHENYLEPHRINE HCLMcKesson Medical-Surgicale09060f7-ca0b-5f7c-e053-2995a90ab3442024-11-08WarningsExact identifier
unii: 04JA59TNSJ
daytime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe0e216ef-300c-4f57-87e6-62a5327e09b42024-11-08WarningsExact identifier
unii: 04JA59TNSJ
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC969c0718-ba6e-4edb-9f55-43bc9500450f2024-11-08WarningsExact identifier
unii: 04JA59TNSJ
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreen Company62a70d9a-4e78-497c-8f75-012ab94e92f62024-11-08WarningsExact identifier
unii: 04JA59TNSJ
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation296f20c0-8b5f-4a08-9329-f93c92e638672024-11-08WarningsExact identifier
unii: 04JA59TNSJ
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC9d147d1e-8ea5-4e0f-8ae8-1da16f1194962024-11-08WarningsExact identifier
unii: 04JA59TNSJ
DG Health Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inc23dcb627-c867-435f-9d1a-a9f49e58b58f2024-11-08WarningsExact identifier
unii: 04JA59TNSJ
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
good sense day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company4ac6b64a-8214-4b03-8aa5-0d3199cf0b722024-11-08WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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