Promethazine
Promethazine is a phenothiazine-type antihistamine used for allergy conditions, motion sickness, nausea and vomiting around surgery, and sedation, and it comes as tablets, oral solution, rectal suppositories and injection.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 82 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Promethazine is an older sedating antihistamine, on the U.S. market since about 1951 and available generically, that blocks histamine to ease allergic rhinitis (hay fever) and hives and calms motion sickness and nausea and vomiting around surgery. Most people tolerate it well enough, but expect drowsiness, often with dry mouth, dizziness or blurred vision. The boxed warning matters most, because promethazine can cause fatal slowed breathing and must never be used in a child under 2, and the injection can cause severe tissue injury, even gangrene, so report any injection-site pain. Skip alcohol and other sedatives, and don't drive until you know how it affects you.
Clinical pearls
- Measure the oral solution with an oral syringe or marked dosing cup, never a kitchen teaspoon.
- For motion sickness, take the first dose before you travel rather than waiting until you feel queasy.
- Promethazine can make skin burn more easily, so use sunscreen and cover up outdoors.
- Sleep apnea, COPD (chronic lung disease) or other breathing problems are reasons the label advises avoiding promethazine, so mention them.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Promethazine injection must never be used in children under 2 years old, because it can cause fatal slowed breathing. Caution is also needed in children 2 and older.
The injection can also cause severe tissue injury, including gangrene. Some people have needed surgery, skin grafts or amputation. It must not be given under the skin or into an artery. Intravenous use at concentrations above 1 mg/mL is also not allowed. Deep intramuscular injection is the preferred route.
If pain occurs at the injection site during an IV infusion, the infusion should be stopped immediately and checked for arterial injection or leakage into surrounding tissue.
Patient information guide A plain-language walkthrough of Promethazine, written from its FDA label.
What Promethazine is used for
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Promethazine is used for allergy, motion sickness, nausea and sedation. The exact uses depend on the product.
- Oral tablets, oral solution and rectal suppositories: allergic rhinitis (year-round and seasonal) and vasomotor rhinitis
- Oral tablets, oral solution and rectal suppositories: allergic conjunctivitis, mild skin allergy (hives, angioedema) and dermographism
- All forms: allergic reactions to blood or plasma
- All forms: anaphylaxis, as an add-on to epinephrine after the acute symptoms are controlled
- Injection: other uncomplicated immediate-type allergic conditions when oral therapy is impossible or contraindicated
- All forms: sedation, including before and after surgery and during labor
- All forms: motion sickness
- All forms: nausea and vomiting with certain anesthesia and surgery
- All forms: add-on to pain medicines after surgery
- Injection: IV use in special surgical situations with reduced narcotic doses
How Promethazine works
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Promethazine is a phenothiazine derivative that blocks histamine H1 receptors. This eases allergy symptoms. It does not stop histamine from being released.
It also has sedative, anti-nausea, motion-sickness and anticholinergic effects. It blocks dopamine only about one-tenth as much as chlorpromazine.
Promethazine dosage
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The form decides how it is given. Tablets and oral solution are taken by mouth. Suppositories are used rectally. The injection is given by a healthcare professional.
- Allergy: the oral label describes a bedtime dose, sometimes with extra doses before meals.
- Motion sickness: take the first dose before travel and repeat later if needed.
- Oral solution: measure with an accurate device, not a household teaspoon.
- Injection: preferably deep into a muscle, or into a vein after dilution.
Dose is adjusted to the smallest amount that relieves symptoms. Follow your prescriber and product label.
Dosing details from the FDA-approved label
From the Promethazine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Allergic conditions (adults)
- The average adult dose is 25 mg
- This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit
- After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms
- Allergic reactions to blood or plasma (adults)
- The average adult dose is 25 mg
- Sedation (hospitalized adult patients, nighttime)
- 25 to 50 mg
- Nausea and vomiting (adults)
- The usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours
- When used for postoperative nausea and vomiting, the dosage of analgesics and barbiturates should be reduced accordingly
- Preoperative and postoperative use (adults)
- 25 to 50 mg may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired
- Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly
- Obstetrics: early stages of labor
- 50 mg will provide sedation and relieve apprehension
- Obstetrics: labor definitely established
- 25 to 75 mg (average dose, 50 mg) with an appropriately reduced dose of any desired narcotic
- May be repeated once or twice at four-hour intervals in the course of a normal labor with a reduced dose of analgesic
- Maximum: A maximum total dose of 100 mg during a 24-hour period
- Pediatric patients 2 years of age and older
- Use the lowest effective dose
- The dosage should not exceed half that of the suggested adult dose
- Maximum: Not to exceed half the suggested adult dose
- Contraindicated in pediatric patients less than 2 years of age
- Pediatric patients 2 years and older: adjunct to premedication
- 1.1 mg per kg of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Promethazine Syrup is contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients ). Allergy The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25-mg doses will control minor transfusion reactions of an allergic nature. Motion Sickness The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, Promethazine Syrup, 12.5 to 25 mg, twice daily, may be administered. Nausea and Vomiting Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS-Use in Pediatric Patients ). The average effective dose of Promethazine for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Promethazine Injection) or by rectal suppository. 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary. Sedation This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Promethazine by the oral route will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Pre- and Postoperative Use Promethazine in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Promethazine side effects
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Drowsiness is the most common effect.
Common side effects
- Drowsiness (the most common effect)
- Dizziness
- Blurred vision
- Dry mouth
- Confusion or disorientation
- Nasal stuffiness
- Nausea or vomiting
- Sensitivity to sunlight
When to get medical help
- Get help right away if a child has slow, shallow or stopped breathing. Promethazine can cause fatal breathing problems in children.
- Get help for fever with muscle stiffness, confusion and an irregular pulse or blood pressure. These can be signs of neuroleptic malignant syndrome.
- Call your doctor about uncontrolled muscle movements, such as twisting of the neck, tongue protrusion or eyes rolling upward.
- Call your doctor for seizures, hallucinations or severe agitation.
- Call your doctor for yellowing of the skin or eyes (jaundice).
- Call your doctor for unusual bruising or bleeding, or signs of low blood cell counts.
- Report swelling (angioneurotic edema) or a severe skin reaction.
- With the injection, tell staff right away about pain at the injection site. Severe tissue damage, including gangrene, can occur.
Seek help for slow breathing, fever with muscle rigidity, seizures, jaundice, unusual bruising or bleeding, or uncontrolled muscle movements.
Promethazine warnings and precautions
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- Slowed breathing can be fatal, especially in children under 2. It is also a risk in people with COPD or sleep apnea.
- The injection can cause severe tissue damage, including gangrene.
- It can cause drowsiness that affects driving and machinery use.
- It may lower the seizure threshold.
- Use with caution in bone-marrow depression, which may involve low white blood cell counts.
- Neuroleptic malignant syndrome is rare but potentially fatal.
- In children, it can cause hallucinations, convulsions and movement symptoms that may be confused with other illness.
- Cholestatic jaundice has been reported.
Promethazine interactions
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Promethazine can add to the effects of other sedating drugs.
- Alcohol, sedatives, barbiturates, narcotics, general anesthetics, tricyclic antidepressants and tranquilizers: more sedation. Doses may need to be reduced.
- Epinephrine: promethazine can reverse its blood-pressure-raising effect, so it should not be used for low blood pressure from overdose.
- Anticholinergic drugs: use with caution.
- MAO inhibitors: more movement-related side effects have been reported.
- Narcotics or local anesthetics: may also lower the seizure threshold.
Interactions listed in the FDA-approved label
From the Promethazine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CNS depressants (alcohol, sedatives/hypnotics including barbiturates, narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, tranquilizers): Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants. Avoid such agents or give them in reduced dosage; reduce barbiturate dose by at least one-half and narcotic dose by one-quarter to one-half; dosage must be individualized.
- Narcotics (excessive promethazine relative to narcotic): Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.
- Epinephrine: Promethazine has the potential to reverse epinephrine's vasopressor effect. Epinephrine should NOT be used to treat hypotension associated with promethazine overdose.
- Anticholinergics: Concomitant use of other agents with anticholinergic properties is addressed with a caution. Undertake concomitant use with caution.
- Monoamine Oxidase Inhibitors (MAOI): Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with promethazine.
Read the label’s full interactions text
Drug Interactions CNS Depressants Promethazine Syrup may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with Promethazine Syrup, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine Because of the potential for Promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine Syrup overdose. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Promethazine Syrup.
CNS Depressants Promethazine Syrup may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Promethazine
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- Not for children under 2 years old.
- Use caution in children 2 and older, and avoid other drugs that slow breathing.
- Not for people in a coma or with a prior reaction to promethazine or other phenothiazines.
- Avoid in breathing problems such as COPD or sleep apnea.
- Use caution with seizure disorders or bone-marrow depression.
- Avoid in children whose symptoms may suggest Reye's syndrome or liver disease.
Promethazine overdose
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Too much promethazine can cause anything from mild drowsiness to very low blood pressure, slowed breathing, unconsciousness and sudden death. Children and older adults may instead become overstimulated. Treatment is supportive, such as protecting the airway and giving fluids. Epinephrine should not be used, and naloxone does not reverse the effects.
What Promethazine does in the body
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Promethazine blocks H1 histamine receptors without stopping histamine release. It has antihistamine, sedative, anti-motion-sickness, anti-nausea and anticholinergic effects. Its dopamine-blocking activity is about one-tenth that of chlorpromazine.
How your body processes Promethazine
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Injection effects begin within about 5 minutes into a vein and within 20 minutes into a muscle. They last four to six hours, and sometimes up to 12 hours. Promethazine is broken down in the liver, and its metabolites appear mainly in urine. Its plasma half-life is roughly 9 to 16 hours after IV use and about 10 hours after IM use.
How to store Promethazine
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Store at 20° to 25°C (68° to 77°F) Protect from light. Dispense in light-resistant , tight container.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Promethazine
83 supplements and herbal products have documented interactions with Promethazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 57
- Minor · 23
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Promethazine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Promethazine — the kind of thing our pharmacy team would talk through with you at the counter.
What is promethazine for?
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Will it make me sleepy?
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Can I give it to my toddler?
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How do I measure the liquid?
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What side effects should worry me?
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Can I take it with my other medicines?
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Is Promethazine available over the counter?
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When was Promethazine first available?
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Who makes Promethazine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Promethazine on HelloPharmacist
Promethazine forms and strengths (how it comes)
Promethazine is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Promethazine inactive ingredients by manufacturer.
Tablet
How this form is used
- Phenergan tablets are used for allergic rhinitis, allergic conjunctivitis and mild skin allergy such as hives.
- Phenergan tablets are used for motion sickness and for nausea and vomiting with anesthesia or surgery.
- Phenergan tablets are used for sedation in adults and children and as an add-on to pain medicines after surgery.
- Promethazine Hydrochloride tablets are contraindicated in children under 2 years old.
- Promethazine Hydrochloride tablets for motion sickness are taken before anticipated travel and repeated later if needed.
Injection
How this form is used
- Phenergan Injection is used for allergic reactions to blood or plasma and for anaphylaxis as an add-on to epinephrine.
- Phenergan Injection is used for other uncomplicated immediate-type allergic conditions when oral therapy is impossible or contraindicated.
- Phenergan Injection is used for sedation, motion sickness, and nausea and vomiting with anesthesia or surgery.
- Phenergan Injection is used as an adjunct to pain medicines after surgery.
- Phenergan Injection is preferably given by deep intramuscular injection.
- Phenergan Injection may be given into a vein only after dilution.
- Promethazine Hydrochloride injection must not be given under the skin or into an artery.
- Promethazine Hydrochloride injection should be stopped if pain occurs at the IV site.
Rectal suppository
How this form is used
- Promethegan suppositories are used for allergic rhinitis, allergic conjunctivitis and mild skin allergy such as hives.
- Promethegan suppositories are used for motion sickness and for nausea and vomiting with anesthesia or surgery.
- Promethegan suppositories are used for sedation and as an add-on to pain medicines after surgery.
Oral solution
How this form is used
- Promethazine hydrochloride oral solution is used for allergic rhinitis, allergic conjunctivitis and mild skin allergy such as hives.
- Promethazine hydrochloride oral solution is used for motion sickness and for nausea and vomiting with anesthesia or surgery.
- Promethazine hydrochloride oral solution is used for sedation, including before or after surgery or during labor.
- Promethazine hydrochloride oral solution should be measured with an accurate device, not a household teaspoon.
- Promethazine hydrochloride oral solution is contraindicated in children under 2 years old.
Promethazine on the U.S. market: products, makers and brands
How Promethazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
44 companies list 129 Promethazine product records with the FDA, mostly as tablet, injection, rectal suppository; the earliest marketing or approval year on record is 1951. Brand names on the directory include Promethegan Suppository, Phenergan, Remsed and 3 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Promethazine is used (Medicaid data)
A general measure of how commonly Promethazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Promethazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Promethazine prescribed? Of the 1,601 medications we measure, Promethazine ranks #156 by Medicaid prescriptions — more than 90% of them.
Utilization by Promethazine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
promethazine hydrochloride 25 MG Oral Tablet Most dispensed
Summed across the 16 of 272 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992447
promethazine hydrochloride 1.25 MG/ML Oral Solution
Summed across the 7 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992432
promethazine hydrochloride 12.5 MG Oral Tablet
Summed across the 4 of 71 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992438
promethazine hydrochloride 25 MG Rectal Suppository
Summed across the 3 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992454
1 ML promethazine hydrochloride 25 MG/ML Injection
Summed across the 8 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992460
promethazine hydrochloride 50 MG Oral Tablet
Summed across the 6 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992475
promethazine hydrochloride 12.5 MG Rectal Suppository
Summed across the 3 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992441
1 ML promethazine hydrochloride 50 MG/ML Injection
Summed across the 6 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992858
promethazine hydrochloride 50 MG Rectal Suppository
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992478
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Promethazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 54 of 515 listed Promethazine NDCs with Medicaid activity.
Compare Promethazine products
A representative set of FDA-listed product records for Promethazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/mL | Intramuscular | A-S Medication Solutions | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Intravenous | Cardinal Health 107, LLC | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Intravenous | Henry Schein, Inc. × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Henry Schein, Inc. | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Intravenous | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | View NDC → |
| 50 mg/mL | Intramuscular, Intravenous | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. × 7 listings | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Hikma Pharmaceuticals USA Inc. × 6 listings | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Intravenous | Medical Purchasing Solutions, LLC × 2 listings | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Intravenous | ProPharma Distribution × 2 listings | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Intravenous | XGen Pharmaceuticals DJB, Inc. | ANDA | View NDC → |
| 50 mg/mL | Intramuscular, Intravenous | XGen Pharmaceuticals DJB, Inc. | ANDA | View NDC → |
| 💊Oral solution | ||||
| 6.25 mg/5 mL | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Atlantic Biologicals Corp | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Atlantic Biologicals Corp. | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Chartwell Governmental & Specialty RX, LLC. | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Cranbury Pharmaceuticals, LLC | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Kesin Pharma Corporation | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | PAI Holdings, LLC dba PAI Pharma | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Quagen Pharmaceuticals Llc | ANDA | View NDC → |
| 6.25 mg/5 mL | Oral | Xttrium Laboratories, Inc. | ANDA | View NDC → |
| 💊Rectal suppository | ||||
| 25 mg | Rectal | A-S Medication Solutions | ANDA | View NDC → |
| 12.5 mg | Rectal | Asclemed USA, Inc. | ANDA | View NDC → |
| 25 mg | Rectal | Asclemed USA, Inc. | ANDA | View NDC → |
| 12.5 mg | Rectal | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Rectal | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 12.5 mg | Rectal | Cosette Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Rectal | Cosette Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Rectal | Cosette Pharmaceuticals, Inc. | ANDA | View NDC → |
| 12.5 mg | Rectal | Padagis Israel Pharmaceuticals Ltd | ANDA | View NDC → |
| 25 mg | Rectal | Padagis Israel Pharmaceuticals Ltd | ANDA | View NDC → |
| 25 mg | Rectal | PD-Rx Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 💊Tablet | ||||
| 12.5 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 25 mg | Oral | A-S Medication Solutions × 8 listings | ANDA | View NDC → |
| 25 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 12.5 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 25 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 12.5 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 25 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 50 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 12.5 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 25 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 50 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 12.5 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 12.5 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 25 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 50 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 12.5 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 25 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 50 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 12.5 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 25 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 50 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 25 mg | Oral | Direct Rx | ANDA | View NDC → |
| 12.5 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 12.5 mg | Oral | KVK-Tech, Inc. | ANDA | View NDC → |
| 25 mg | Oral | KVK-Tech, Inc. | ANDA | View NDC → |
| 50 mg | Oral | KVK-Tech, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 25 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 25 mg | Oral | Northwind Health Company, LLC × 5 listings | ANDA | View NDC → |
| 25 mg | Oral | NuCare Pharmaceuticals,Inc. × 6 listings | ANDA | View NDC → |
| 12.5 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | PD-Rx Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | PD-Rx Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | PharmPak, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Proficient Rx LP × 4 listings | ANDA | View NDC → |
| 25 mg | Oral | Redpharm Drug | ANDA | View NDC → |
| 12.5 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 25 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 12.5 mg | Oral | Sportpharm LLC | ANDA | View NDC → |
| 25 mg | Oral | Sportpharm LLC | ANDA | View NDC → |
| 50 mg | Oral | Sportpharm LLC | ANDA | View NDC → |
| 25 mg | Oral | Unit Dose Solutions, Inc. | ANDA | View NDC → |
| 12.5 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 25 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 50 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 12.5 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 25 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 50 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
Showing 129 of 129 products — FDA National Drug Code Directory. See every product, package size and price: browse all 129 Promethazine NDCs →
Promethazine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Promethazine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Promethazine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Promethazine FDA approval history
How Promethazine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Promethazine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Promethazine recalls since July 2021.
✅No Promethazine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 8745 4 dose forms · 13 strengths
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Dose form (SCDF) Injection RxCUI 1724826In current FDA listingsClinical drug / strength (SCD) 1 ML promethazine hydrochloride 25 MG/MLRxCUI 9924601 ML promethazine hydrochloride 50 MG/MLRxCUI 992858 -
Dose form (SCDF) Oral Solution RxCUI 450999In current FDA listingsClinical drug / strength (SCD) hydrochloride 1 MG/MLRxCUI 992898hydrochloride 1.25 MG/MLRxCUI 992432hydrochloride 5 MG/MLRxCUI 992471 -
Dose form (SCDF) Oral Tablet RxCUI 373630In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 992900hydrochloride 12.5 MGRxCUI 992438hydrochloride 20 MGRxCUI 992904hydrochloride 25 MGRxCUI 992447hydrochloride 50 MGRxCUI 992475 -
Dose form (SCDF) Rectal Suppository RxCUI 373632In current FDA listingsClinical drug / strength (SCD) hydrochloride 12.5 MGRxCUI 992441hydrochloride 25 MGRxCUI 992454hydrochloride 50 MGRxCUI 992478
Look up RxCUI 8745 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Promethazine supply and shortage status
Whether Promethazine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Promethazine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 25 mg | $0.045 per tablet | NDC details & price history |
| Tablet · Oral | 12.5 mg | $0.047 per tablet | NDC details & price history |
| Tablet · Oral | 50 mg | $0.082 per tablet | NDC details & price history |
| Suppository · Rectal | 25 mg | $2.03 each | NDC details & price history |
| Suppository · Rectal | 12.5 mg | $1.85 each | NDC details & price history |
| Suppository · Rectal | 50 mg | $26.69 each | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Promethazine brand names
Promethazine is sold under 6 brand names in the FDA directory — Promethegan Suppository, Phenergan, Remsed, Promethegan and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Promethazine: manufacturers and labelers
44 companies list Promethazine products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., A-S Medication Solutions, Asclemed USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 20 more on the FDA NDC directory.
Promethazine drug class (RxNorm)
Promethazine belongs to the Phenothiazine class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Promethazine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. PharmPak, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →