Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Where is Brompheniramine and Dextromethorphan and Pseudoephedrine made?
10 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 5 factories in India, the United States and Israel.
India 2United States 2Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bionpharma Inc.2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 69452-478 | Brio Pharmaceuticals, IncMakes it | Houston, TX, United States | Problems found, fixed voluntarilyFeb 2026 |
| OrBion Pharmaceuticals Private LimitedMakes it | Kancheepuram, India | No problems foundOct 2025 | |
| Ascend Laboratories, LLC2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 67877-558 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Eywa Pharma Inc2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 71930-026 | Wes Pharma IncMakes it, packages it and labels it | Westminster, MD, United States | Problems found, fixed voluntarilyNov 2025 |
| Taro Pharmaceuticals U.S.A., Inc.2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 51672-4165 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Acella Pharmaceuticals, LLC2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 42192-630, 42192-607 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 68999-302 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 62135-302 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 75907-207 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 0574-1104 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL · NDC 0121-0933 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Brompheniramine and Dextromethorphan and Pseudoephedrine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-5625 - Bryant Ranch Prepack:
63629-8616,72162-1123,63629-8615 - Physicians Total Care, Inc.:
54868-6377 - Proficient Rx LP:
63187-664,63187-930 - Remedyrepack Inc.:
70518-4526 - Sportpharm LLC:
85766-250
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.