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 52 of 125 · 2,491 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLWal-Mart Stores,Inc.,2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc2025-10-27WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPharmacy Value Alliance LLC903b77fc-02bf-73b6-e053-2a95a90ad4cc2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCVS Pharmacy845fc11b-707d-2027-e053-2991aa0a1c8a2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmerisourcebergen Drug Corporation231a850a-bad6-9a30-e063-6394a90a0fdc2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLC.41eec9e9-6e94-15d4-e063-6394a90a98a22025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 1666372
unii: 04JA59TNSJ
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Daytime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)17640528-c1f7-4881-ba86-bb3f488a952c2025-10-24WarningsExact identifier
unii: 04JA59TNSJ
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: 451W47IQ8X
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
unii: 04JA59TNSJ
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
unii: 04JA59TNSJ
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
unii: 04JA59TNSJ
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories, Inc41afb883-1158-9764-e063-6294a90a17122025-10-21WarningsExact identifier
unii: 04JA59TNSJ
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI311e2b6b-21cb-4b4c-a78d-a0732d29602f2025-10-21WarningsExact identifier
unii: 04JA59TNSJ
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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