Active substance
Promethazine
- SFDA 6
- US FDA 92
- Health Canada 1
- US price lines 13
- NHS prices 6
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| HISTALOC 25MG F.C. TABLETS | 25 mg | Film-coated tablet · Oral use | 20 Blister | SAR 4.15 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| HISTALOC 5MG-5ML SYRUP | 1 mg/ml | Syrup · Oral use | 1 Bottle | SAR 4.75 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| PROMETIN 5MG\5ML SYRUP | 1 mg/ml | Syrup · Oral use | 1 Bottle | SAR 4.45 | Generic · Prescription | KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| HISTALOC 10MG F.C TAB | 10 mg | Film-coated tablet · Oral use | 20 Blister | SAR 2.55 | NCE · Prescription | Gulf Pharmaceutical Industries (Julphar) | Withdrawn by MAH · Not Marketed |
| HISTAZIN 5MG\5ML SYRUP | 1.2 mg/ml | Syrup · Oral use | 1 Bottle | SAR 3.85 | Generic · Prescription | UNITED PHARMACEUTICAL CO. | Withdrawn by MAH · Not Marketed |
| PROMANTINE SYRUP | 1.2 mg/ml | Syrup · Oral use | 1 Bottle | SAR 5.75 | NCE · Prescription | MISR COMPANY FOR MEDICAL PRODUCTS | Invalid · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE COUGH; ANESTHESIA; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; HUMAN IMMUNODEFICIENCY VIRUS; INSOMNIA; JET LAG - INSOMNIA; NAUSEA AND VOMITING IN CANCER; PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS - PRURITUS; TUBERCULOSIS-SUPPORTIVE CARE; URTICARIA; VERTIGO - MOTION SICKNESS; VERTIGO -BENIGN PAROXYSMAL POSITIONAL VERTIGO AND ACUTE VESTIBULAR NEURONITIS OR LABYRINTHITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | 25MG/ML; 50MG/ML | injectable · injection | HIKMA | Prescription | 19 Sep 1973 |
| PROMETHAZINE HYDROCHLORIDE | 25MG | tablet · oral | WATSON LABS | Prescription | 19 Sep 1973 |
| PROMETHAZINE HYDROCHLORIDE | 50MG | tablet · oral | WATSON LABS | Prescription | 21 Sep 1973 |
| PROMETHAZINE HYDROCHLORIDE | 50MG; 25MG | tablet · oral | SANDOZ | Prescription | 18 Feb 1975 |
| PROMETHAZINE PLAIN | 6.25MG/5ML | syrup · oral | PHARMOBEDIENT | Prescription | 15 Nov 1982 |
| PROMETHEGAN | 50MG | suppository · rectal | COSETTE PHARMS NC | Prescription | 14 Aug 1987 |
| PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | syrup · oral | CHARTWELL RX | Prescription | 25 Sep 1998 |
| PROMETHAZINE HYDROCHLORIDE | 25MG; 12.5MG | suppository · rectal | COSETTE PHARMS NC | Prescription | 5 Feb 2002 |
| PROMETHAZINE HYDROCHLORIDE | 12.5MG; 25MG | suppository · rectal | PADAGIS ISRAEL | Prescription | 30 Jun 2003 |
| PROMETHAZINE HYDROCHLORIDE | 12.5MG; 25MG; 50MG | tablet · oral | ZYDUS PHARMS USA | Prescription | 18 Nov 2005 |
| PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | syrup · oral | PHARM ASSOC | Prescription | 26 Apr 2006 |
| PROMETHAZINE HYDROCHLORIDE | 12.5MG; 25MG; 50MG | tablet · oral | PRINSTON INC | Prescription | 18 Jul 2006 |
| PROMETHAZINE HYDROCHLORIDE | 25MG; 12.5MG; 50MG | tablet · oral | KVK TECH | Prescription | 31 Jul 2006 |
| PROMETHAZINE HYDROCHLORIDE | 50MG | tablet · oral | KVK TECH | Prescription | 31 Jul 2006 |
| PROMETHAZINE HYDROCHLORIDE | 12.5MG; 25MG; 50MG | tablet · oral | QUAGEN | Prescription | 5 Mar 2008 |
| PROMETHAZINE HYDROCHLORIDE | 25MG/ML; 50MG/ML | injectable · injection | XGEN PHARMS | Prescription | 24 Apr 2008 |
| PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | syrup · oral | STRIDES PHARMA | Prescription | 13 Mar 2009 |
| PROMETHAZINE HYDROCHLORIDE | 12.5MG; 25MG; 50MG | tablet · oral | AMNEAL PHARMS NY | Prescription | 13 Dec 2010 |
| PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | syrup · oral | COSETTE PHARMS NC | Prescription | 28 Jun 2012 |
| PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | syrup · oral | QUAGEN | Prescription | 12 Jul 2021 |
| PROMETHAZINE HYDROCHLORIDE | 12.5MG; 25MG | suppository · rectal | ANNORA PHARMA | Prescription | 2 Nov 2022 |
| PHENERGAN | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | DELCOR ASSET CORP | Discontinued | 29 Mar 1951 |
| PROMETHAZINE HYDROCHLORIDE PLAIN | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | syrup · oral | ANI PHARMS | Discontinued | 11 Apr 1952 |
| PHENERGAN | 25MG/ML; 50MG/ML | injectable · injection | WYETH AYERST | Discontinued | 20 Aug 1956 |
| PHENERGAN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | suppository · rectal | PHARMOBEDIENT | Discontinued | 5 May 1958 |
67 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| HISTANTIL TAB 50MG | 00575186 | 50 MG | TABLET · ORAL | PHARMASCIENCE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PROMETHAZINE 12.5 MG SUPPOS | $1.85416 | per EA | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 12.5 MG TABLET | $0.05434 | per EA | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 25 MG SUPPOSITORY | $2.03477 | per EA | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 25 MG TABLET | $0.04548 | per EA | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 25 MG/ML AMPUL | $1.33454 | per ML | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 25 MG/ML VIAL | $1.74825 | per ML | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 50 MG TABLET | $0.08196 | per EA | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 50 MG/ML AMPUL | $2.33887 | per ML | 20 May 2026 |
| US NADAC | PROMETHAZINE 6.25 MG/5 ML SOLN | $0.04198 | per ML | 23 Sep 2026 |
| US NADAC | PROMETHAZINE 6.25 MG/5 ML SYRP | $0.04198 | per ML | 23 Sep 2026 |
| US NADAC | PROMETHEGAN 12.5 MG SUPPOS | $1.85416 | per EA | 23 Sep 2026 |
| US NADAC | PROMETHEGAN 25 MG SUPPOSITORY | $2.03477 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Promethazine 25mg/1ml solution for injection ampoules | £6.74 | 10 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Promethazine 5mg/5ml oral solution sugar free | £4.08 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Promethazine hydrochloride 10mg tablets | £1.71 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Promethazine hydrochloride 20mg tablets | £1.89 | 8 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Promethazine hydrochloride 20mg tablets | £2.69 | 16 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Promethazine hydrochloride 25mg tablets | £2.32 | 56 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 MEPERGAN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 PHENERGAN VC W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 PHENERGAN W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Promethazine
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.