Indications and uses
Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock.
Phenylephrine Hydrochloride
- Manufacturer
- Fresenius Kabi USA, LLC
- Effective date
- 2025-05-15
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-05-31 21:35:54
Label at a glance#
ProductPhenylephrine Hydrochloride
Active ingredientPhenylephrine Hydrochloride
Label structure17 sections
Dosage and administration
• Phenylephrine Hydrochloride Injection 10 mg/mL MUST BE DILUTED before administration as an intravenous bolus or for continuous intravenous infusion. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions (2°C – 8°C). Parenteral drug products should be inspected for particulate matter and discoloration prior to administration. Disc...
Storage and handling
Phenylephrine Hydrochloride Injection, USP, is supplied as follows: Product Code Unit of Sale Strength Each RF751101 NDC 65219-388-01 Unit of 25 10 mg per mL NDC 65219-388-00 1 mL Single Dose Vial This product is RFID enabled. 751101 NDC 63323-751-01 Unit of 25 10 mg per mL NDC 63323-751-00 1 mL Single Dose Vial Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controll...
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchWebsitewww.fresenius-kabi.com
www.fresenius-kabi.com/us
www.fresenius-kabi.com/usLabel contents#
Full prescribing information#
1 INDICATIONS AND USAGE
Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock.
2 DOSAGE AND ADMINISTRATION
2.1 General Administration Instructions
- Phenylephrine Hydrochloride Injection 10 mg/mL MUST BE DILUTED before administration as an intravenous bolus or for continuous intravenous infusion. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions (2°C – 8°C).
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration.
Discard any unused portion.
During Phenylephrine Hydrochloride Injection 10 mg/mL administration:
- Correct intravascular volume depletion.
- Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.
2.2 Preparation of Phenylephrine Hydrochloride Injection
SPL UNCLASSIFIED SECTION
Preparing a 100 mcg/mL Solution for Intravenous Bolus Administration
For intravenous bolus administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of Phenylephrine Hydrochloride Injection 10 mg/mL and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. This will yield a final concentration of 100 mcg/mL. Withdraw an appropriate dose from the 100 mcg/mL solution prior to intravenous bolus administration.
SPL UNCLASSIFIED SECTION
Preparing a 20 mcg/mL Solution for Continuous Intravenous Infusion
For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection 10 mg/mL and add to 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (providing a final concentration of 20 mcg/mL).
SPL UNCLASSIFIED SECTION
Dosing for Perioperative Setting
In adult patients undergoing surgical procedures with either neuraxial anesthesia or general anesthesia:
- Phenylephrine Hydrochloride Injection 10 mg/mL (diluted to 20 mcg/mL): 0.5 mcg/kg/min to 1.4 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal.
SPL UNCLASSIFIED SECTION
Dosing for Septic or Other Vasodilatory Shock
In adult patients with septic or other vasodilatory shock:
- No bolus.
- 0.5 mcg/kg/min to 6 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Doses above 6 mcg/kg/min do not show significant incremental increase in blood pressure.
3 DOSAGE FORMS AND STRENGTHS
Phenylephrine Hydrochloride Injection, USP:
- 10 mg per mL phenylephrine hydrochloride is supplied as a 1 mL single dose vial.
4 CONTRAINDICATIONS
The use of Phenylephrine Hydrochloride Injection 10 mg/mL is contraindicated in patients with:
- Hypersensitivity to the product or any of its components
5 WARNINGS AND PRECAUTIONS
5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension
Because of its pressor effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
5.2 Bradycardia
Phenylephrine Hydrochloride Injection 10 mg/mL can cause severe bradycardia and decreased cardiac output.
5.3 Risk in Patients with Autonomic Dysfunction
The pressor response to adrenergic drugs, including phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
5.4 Skin and Subcutaneous Necrosis
Extravasation of phenylephrine can cause necrosis or sloughing of tissue.
5.5 Pressor Effect with Concomitant Oxytocic Drugs
Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines including Phenylephrine Hydrochloride Injection 10 mg/mL [see Drug Interactions (7.1)], with the potential for hemorrhagic stroke.
5.7 Peripheral and Visceral Ischemia
Phenylephrine Hydrochloride Injection 10 mg/mL can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
5.8 Renal Toxicity
Phenylephrine Hydrochloride Injection 10 mg/mL can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.
6 ADVERSE REACTIONS
The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Cardiac disorders: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia
Gastrointestinal disorders: Nausea, vomiting
General disorders and administrative site conditions: Chest pain, extravasation
Immune system disorders: Sulfite sensitivity
Nervous system disorders: Headache, nervousness, paresthesia, tremor
Psychiatric disorders: Excitability
Respiratory: Pulmonary edema, rales
Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation
Vascular disorders: Hypertensive crisis
7 DRUG INTERACTIONS
Agonists
The pressor effect of phenylephrine hydrochloride is increased in patients receiving:
- Monoamine oxidase inhibitors (MAOI), such as selegiline.
- β-adrenergic blockers
- α-2 adrenergic agonists, such as clonidine
- Steroids
- Tricyclic antidepressants
- Norepinephrine transport inhibitors, such as atomoxetine
- Ergot alkaloids, such as methylergonovine maleate
- Centrally-acting sympatholytic agents, such as guanfacine or reserpine
- Atropine sulfate
7.2 Antagonists
α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
SPL UNCLASSIFIED SECTION
Risk Summary
In animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (HDD) of 10 mg. No malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the HDD.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
SPL UNCLASSIFIED SECTION
Data
SPL UNCLASSIFIED SECTION
Animal Data
No malformations were noted when normotensive pregnant rats were treated with a single daily intravenous bolus dose of 50 mcg, 150 mcg, or 300/200 mcg/kg phenylephrine hydrochloride from Gestation Day 6 to 17 (high dose is 0.3/0.2 times the human daily dose (HDD) of 10 mg/day based on body surface area). Evidence of maternal toxicity, including mortality, was noted at the highest tested dose of 300/200 mcg/kg.
Decreased fetal body weights but no clear treatment-related malformations were reported when normotensive pregnant rabbits were treated with a single daily intravenous bolus dose of 40 mcg, 100 mcg and 200 mcg/kg (0.08, 0.2, and 0.4 times the HDD based on body surface area) phenylephrine hydrochloride from Gestation Day 7 to 19. Maternal toxicity, as manifested by decreased food consumption and body weight gain at all doses. An increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was noted in all treatment groups compared to controls.
No adverse effects on the offspring were reported when pregnant rats were treated via a single daily intravenous bolus dose of up to 200 mcg/day phenylephrine hydrochloride (0.2 times the HDD based on body surface area) from Gestation Day 6 to Lactation Day 20.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
8.6 Hepatic Impairment
In patients with liver cirrhosis [Child Pugh Class A (n=3), Class B (n=5) and Class C (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. Consider using larger doses than usual in hepatic impaired subjects.
8.7 Renal Impairment
In patients with end stage renal disease (ESRD) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. Consider using lower doses of phenylephrine hydrochloride in ESRD patients.
10 OVERDOSAGE
Overdose of phenylephrine hydrochloride injection 10 mg/mL can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia, and may cause a sensation of fullness in the head and tingling of the extremities. Consider using an α-adrenergic antagonist.
11 DESCRIPTION
Phenylephrine Hydrochloride Injection contain active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection. Chemically, phenylephrine hydrochloride is (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula:
Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride is sensitive to light.
Phenylephrine Hydrochloride Injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter. It MUST BE DILUTED before administration as bolus intravenous infusion or continuous intravenous infusion.
Each mL contains: Phenylephrine Hydrochloride 10 mg; Sodium Chloride 3.5 mg; Sodium Citrate Dihydrate 4 mg; and Citric Acid 1 mg in water for injection. The pH may be adjusted in the range of 3.5 to 5.5 with Sodium Hydroxide and/or Hydrochloric Acid, if necessary.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.
12.2 Pharmacodynamics
Phenylephrine is the active moiety. Metabolites are inactive at both the α-1and α-2 adrenergic receptors. Following parenteral administration of phenylephrine hydrochloride, increases in systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid and the effect may persist for up to 20 minutes. As mean arterial pressure increases following parenteral doses, vagal activity also increases, resulting in reflex bradycardia.
Most vascular beds are constricted, including renal, splanchnic, and hepatic.
12.3 Pharmacokinetics
Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. The steady-state volume of distribution (340 L) exceeded the body volume by a factor of 5, suggesting a high distribution into certain organ compartments. The average total serum clearance (2095 mL/min) was close to one-third of the cardiac output.
A mass balance study showed that phenylephrine is extensively metabolized by the liver with only 12% of the dose excreted unchanged in the urine. Deamination by monoamino oxidase is the primary metabolic pathway resulting in the formation of the major metabolite (m-hydroxymandelic acid) which accounts for 57% of the total administered dose.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
SPL UNCLASSIFIED SECTION
Carcinogenesis:
Long-term animal studies that evaluated the carcinogenic potential of orally administered phenylephrine hydrochloride in F344/N rats and B6C3F1 mice were completed by the National Toxicology Program using the dietary route of administration. There was no evidence of carcinogenicity in mice administered approximately 270 mg/kg/day (131-times the human daily dose (HDD) of 10 mg/day based on body surface area) or rats administered approximately 50 mg/kg/day (48-times the HDD based on body surface area comparisons).
SPL UNCLASSIFIED SECTION
Mutagenesis:
Phenylephrine hydrochloride tested negative in the in vitro bacterial reverse mutation assay (S. typhimurium strains TA98, TA100, TA1535 and TA1537), the in vitro chromosomal aberrations assay, the in vitro sister chromatid exchange assay, and the in vivo rat micronucleus assay. Positive results were reported in only one of two replicates of the in vitro mouse lymphoma assay.
SPL UNCLASSIFIED SECTION
Impairment of Fertility:
No adverse effects on fertility or early embryonic development were noted when phenylephrine hydrochloride was administered at doses of 50 mcg, 100 mcg, or 200 mcg/kg/day (up to 0.2 times HDD of 10 mg/60 kg/day based on body surface area) via single daily bolus injection for 28 days prior to mating to male rats or for 14 days prior to mating through Gestation Day 7 to female rats.
14 CLINICAL STUDIES
Increases in systolic and mean blood pressure following administration of phenylephrine were observed in 42 literature-based studies in the perioperative setting, including 26 studies where phenylephrine was used in low- risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during cesarean delivery, 3 studies in non- obstetric surgery under neuraxial anesthesia, and 13 studies in patients undergoing surgery under general anesthesia. Mean arterial blood pressure increases were also observed in two double-blind, active-controlled studies in patients with septic shock.
16 HOW SUPPLIED/STORAGE AND HANDLING
Phenylephrine Hydrochloride Injection, USP, is supplied as follows:
Product Code | Unit of Sale | Strength | Each |
RF751101 | NDC 65219-388-01 | 10 mg per mL | NDC 65219-388-00 |
751101 | NDC 63323-751-01 | 10 mg per mL | NDC 63323-751-00 |
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. For single use only. Discard unused portion.
17 PATIENT COUNSELING INFORMATION
Inform patients, families, or caregivers that the primary side effect of phenylephrine is hypertension and, rarely, hypertensive crisis. Patients may experience bradycardia (slow heart rate), which in some cases may produce heart block or other cardiac arrhythmias, extra ventricular beats, myocardial ischemia in patients with underlying cardiac disease, and pulmonary edema (fluid in the lungs) or rales. Common, less serious symptoms include the following:
- chest pain
- skin or tissue damage if the drug leaks out of the venous catheter into the surrounding tissue
- headache, nervousness, tremor, numbness/tingling (paresthesias) in hands or feet
- nausea, vomiting
- excitability, dizziness, sweating, flushing
Lake Zurich, IL 60047 www.fresenius-kabi.com/us
451579C
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Phenylephrine 1 mL Vial Label
NDC 63323-751-00 751101
Phenylephrine
Hydrochloride
Injection, USP
10 mg per mL
For Intravenous Use
Dilute Before Use
DISCARD UNUSED PORTION
PROTECT FROM LIGHT
1 mL Single Dose Vial Rx only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Phenylephrine 1 mL Vial Tray Label
NDC 63323-751-01 751101
Phenylephrine Hydrochloride
Injection, USP
10 mg per mL
For Intravenous Use
Dilute Before Use
DISCARD UNUSED PORTION
Rx only
25 x 1 mL Single Dose Vials
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-751-00 | Phenylephrine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | 8 | |
| 63323-751-01 | Phenylephrine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-751-00 | ML - Milliliter | 63323-751 | 1394c34e-4c42-4094-b1b2-afcdc13e132b | 1 | 2019-07-02 |
| 63323-751-01 | ML - Milliliter | 63323-751 | a8b40ddc-6423-477a-9e40-f4a05b934ade | 1 | 2019-07-02 |
| 63323-751-03 | ML - Milliliter | 63323-751 | cf951bf5-4a25-4cb0-9c6b-c9e4c8cb2180 | 1 | 2020-08-06 |
| 63323-751-05 | ML - Milliliter | 63323-751 | 321cea9d-af97-405d-9cb3-812f3c5e23d3 | 1 | 2019-07-02 |
| 63323-751-10 | ML - Milliliter | 63323-751 | 9610d875-e8cc-4c7b-83b7-8b4ebf6a4e9e | 1 | 2019-07-02 |
| 63323-751-13 | ML - Milliliter | 63323-751 | ec8453b5-99f8-4776-90d2-3d17719905cf | 1 | 2020-08-06 |
Products#
Every source-derived product name is available through these pages.
- Phenylephrine Hydrochloride
- Phenylephrine
- Sodium Chloride
- Trisodium Citrate Dihydrate
- Citric Acid Monohydrate
- Water
- Sodium Hydroxide
- Hydrochloric Acid
- Nitrogen
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63323-751 | 63323-751-00, 63323-751-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Phenylephrine Hydrochloride | 04JA59TNSJ | ACTIB |
| Sodium Chloride | 451W47IQ8X | IACT |
| Trisodium Citrate Dihydrate | B22547B95K | IACT |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
| Hydrochloric Acid | QTT17582CB | IACT |
| Nitrogen | N762921K75 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210665-001 | AP2 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
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|---|---|---|---|---|---|---|---|---|---|
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| 2026-08-18 06:07:40 | 2026-07 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 011fe1cb6892… | |
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| 2025-08-23 18:47 UTC | 2025-08 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 6a471c1ec25d… | |
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| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 03ed91905a0d… | |
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| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 5bbf6a4d5a75… | |
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| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2019-01-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2019-01-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A210665-001 | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP2 | 2019-01-29 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210665-001 | AP2 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210665-001 | AP2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210665-001 | AP2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210665-001 | AP2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210665-001 | AP2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210665-001 | AP2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210665-001 | AP2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210665-001 | AP2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210665-001 | AP2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210665-001 | AP2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210665-001 | AP2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210665-001 | AP2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210665-001 | AP2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210665-001 | AP2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210665-001 | AP2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210665-001 | AP2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210665-001 | AP2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210665-001 | AP2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210665-001 | AP2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210665-001 | AP2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210665-001 | AP2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210665-001 | AP2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210665-001 | AP2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A210665-001 | AP2 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A210665-001 | AP2 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A210665-001 | AP2 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A210665-001 | AP2 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A210665-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A210665-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210665-001 | AP2 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A210665-001 | AP2 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A210665-001 | AP2 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210665-001 | AP2 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210665-001 | AP2 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210665-001 | AP2 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210665-001 | AP2 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A210665-001 | AP2 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A210665-001 | AP2 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210665-001 | AP2 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A210665-001 | AP2 | 1 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7 | 2025-05-15 | Warnings, Adverse reactions | 63323-751-01 63323-751-00 63323-751 63323075100 63323075101 74cccfa6-0838-4325-8775-53d786e9c72d 1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | f2dce7f1-6538-4747-9792-665eee45c0a9 | 2023-12-11 | Warnings, Adverse reactions | 63323-751 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | c7026b15-1228-4acb-beed-4474fcdbb972 | 2022-10-11 | Warnings, Adverse reactions | 63323-751 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.