Prescription medicine
Promethazine Brand names: Phenergan, Promethegan
Promethazine (Phenergan) is a prescription medicine with an FDA approval on record since 1951. FDA's NDC Directory lists it from 47 generic labelers, and pharmacies paid $0.0455 per promethazine 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the promethazine FDA label on DailyMed (effective March 13, 2026, KVK-Tech, Inc.); the NDA 7935 record on Drugs@FDA; every promethazine label on DailyMed.
Highlights of the record
FDA label of March 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePromethazine hydrochloride tablet is useful for: Perennial and seasonal allergic rhinitis.
Forms and strengths
- 12.5 mg
- 25 mg
- 50 mg
- 6.25 mg/5ml
- 25 mg/ml
- 50 mg/ml
Tablet; injection; suppository; solution; syrup.
On the market
- Earliest approval on file
- March 29, 1951 Phenergan, Delcor Asset Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 67 first March 6, 1973; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 47 of which 47 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0455 per tablet Promethazine 25 mg tablet
- Shortage (FDA)
- 7 of 10 presentations limited or unavailable updated September 22, 2026
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest April 13, 2022; 7 more by firms not listed as its makers
- FAERS reports
- 18,478 through July 30, 2026
What is promethazine used for?
From the label: indications and usagePromethazine hydrochloride tablet is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. […]
FDA pharmacologic class: Phenothiazine.
Source: FDA drug label (PROMETHAZINE HYDROCHLORIDE), KVK-Tech, Inc., effective March 13, 2026 (SPL set 7a137adf-39b7-4b14-80da-c3cac9ad562a), via openFDA; the full label on DailyMed
Is there a generic for promethazine (Phenergan)?
The FDA approved the first generic promethazine on March 6, 1973. 67 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists promethazine from 47 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1951 earliest approval on file
- 1973 first generic approved
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for promethazine (Phenergan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0455 per Promethazine 25 mg tablet, down 9% from $0.0498 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Promethazine 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Promethazine 12.5 mg suppos | Generic | $1.85 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -14% |
| Promethazine 12.5 mg tablet | Generic | $0.0543 per tablet | $1.63 | +7% |
| Promethazine 25 mg suppository | Generic | $2.03 per suppository many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -2% |
| Promethazine 25 mg tablet | Generic | $0.0455 per tablet | $1.36 | -9% |
| Promethazine 25 mg/mL ampul | Generic | $1.33 per mL | n/a | -18% |
| Promethazine 25 mg/mL vial | Generic | $1.75 per mL | n/a | +0.9% |
| Promethazine 50 mg tablet | Generic | $0.082 per tablet | $2.46 | -7% |
| Promethazine 50 mg/mL ampul | Generic | $2.34 per mL | n/a | -2% |
| Promethazine 6.25 mg/5 mL solution | Generic | $0.042 per mL | n/a | +2% |
| Promethazine 6.25 mg/5 mL syrp | Generic | $0.042 per mL | n/a | +2% |
| Promethegan 12.5 mg suppos | Generic | $1.85 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -14% |
| Promethegan 25 mg suppository | Generic | $2.03 per suppository many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -2% |
| Promethegan 50 mg suppository | Generic | $26.69 per suppository many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is promethazine in shortage?
The FDA Drug Shortage Database lists 7 of 10 promethazine presentations as limited or unavailable (updated September 22, 2026); the first entry was posted on November 21, 2023. 3 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Phenergan, Injection, 25 mg/1 mL (NDC 0641-6082-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Phenergan, Injection, 25 mg/1 mL (NDC 0641-6084-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Phenergan, Injection, 50 mg/1 mL (NDC 0641-6085-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 39822-5525-3) | XGen Pharmaceuticals DJB, Inc. | Current | September 22, 2026 |
| Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
Every promethazine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has promethazine been recalled?
The FDA's Enforcement Report lists 9 recalls naming promethazine since 2013: 0 Class I (the most serious), 9 Class II, 0 Class III; 1 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of promethazine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| December 17, 2018 | Class II | Duren Health Mart Pharmacy not a listed maker | Lack of Processing Controls. |
| April 20, 2016 | Class II | Pharmakon Pharmaceuticals, Inc. not a listed maker | Lack of Assurance of Sterility |
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
| May 8, 2014 | Class II | Zydus Pharmaceuticals USA Inc | Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the promethazine label say about other medicines?
The promethazine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 5 other medicines name promethazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | drug interactions | Because of the potential for promethazine hydrochloride to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride tablets overdose. |
Other labels that name promethazine
Source: FDA drug label (PROMETHAZINE HYDROCHLORIDE), KVK-Tech, Inc., effective March 13, 2026 (SPL set 7a137adf-39b7-4b14-80da-c3cac9ad562a), via openFDA; the full label on DailyMed
What do FAERS reports show for promethazine?
The FDA Adverse Event Reporting System holds 18,478 reports that list promethazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,793 are coded as a death and 7,330 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other phenothiazines
- the pharmacologic class, with prices and generics
- Promethazine side effects
- the label's list beside FAERS reports
- Promethazine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other