Histamine-1 Receptor Antagonist
Where is Diphenhydramine made?
13 companies sell it under their own name and 15 repackagers rebottle it. Their labels name 10 factories in the United States and India.
United States 6India 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC50 mg per 1 mL · NDC 63323-664, 76045-102, 76045-235 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Fresenius Kabi USA, LLC50 mg per 1 mL · NDC 65219-820 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Camber Pharmaceuticals Inc.12.5 mg per 5 mL, 25 mg per 10 mL · NDC 31722-600, 31722-601 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Fusion Pharmaceuticals LLC0.75 g per 0.75 g, 0.86 g per 0.86 g · NDC 43093-104, 70332-103 | California Pharmaceuticals LLCMakes it | Camarillo, California, United States | Problems found, fixed voluntarilyDec 2018 |
| Gland Pharma Limited50 mg per 1 mL · NDC 68083-611 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.50 mg per 1 mL · NDC 23155-264, 23155-263 | Maiva Pharma Private LimitedMakes it, tests it, packages it and labels it | Hosur, India | Problems found, fixed voluntarilyOct 2022 |
| Hikma Pharmaceuticals USA Inc.50 mg per 1 mL · NDC 0641-0376, 0641-6282 | Hikma Pharmaceuticals USA Inc.Makes it, tests it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Micro Labs Limited50 mg per 1 mL · NDC 42571-511, 42571-169, 42571-337 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Pharmaceutical Associates, Inc.12.5 mg per 5 mL, 25 mg per 10 mL · NDC 0121-0489, 0121-0978 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it | Greenville, SC, United States | No problems foundAug 2025 |
| Armas Pharmaceuticals Inc.50 mg per 1 mL · NDC 72485-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avenacy Inc.50 mg per 1 mL · NDC 83634-781 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Redmont Pharmaceuticals, LLC12.5 mg per 5 mL · NDC 71741-511 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals50 mg per 1 mL · NDC 25021-481 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Diphenhydramine 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:
50090-1841,50090-0878 - Cardinal Health 107, LLC:
55154-5102,55154-9363 - Coupler Enterprises Inc.:
67046-127 - Dispensing Solutions Inc.:
55045-3683 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1218,51662-1348,51662-1219,51662-1374 - Health Department, Oklahoma State:
83112-555 - Henry Schein, Inc.:
0404-9851 - Medical Purchasing Solutions, LLC.:
71872-7242,71872-7005,71872-7180,71872-7373 - ProPharma Distribution:
84549-101 - Rebel Distributors Corp..:
42254-190 - Remedyrepack Inc.:
70518-1082,70518-4455,70518-4536,70518-4765 - Sina Health Inc:
70385-2007 - Sportpharm LLC:
85766-253 - State of Florida DOH Central Pharmacy:
53808-0238 - TYA Pharmaceuticals:
64725-0376
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Mar 6, 2015 · Class II · Fusion Pharmaceuticals, LLC
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.