Drug
Who makes diphenhydramine hydrochloride?
19 companies list diphenhydramine hydrochloride as a human prescription drug. Forms: injection; injection, solution; solution. Routes: intramuscular, intravenous, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing diphenhydramine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA040466, ANDA091526 | 4 | 6 |
| Medical Purchasing Solutions, LLCUnited States | injection; injection, solution; solution | ANDAANDA080817, ANDA087513, ANDA205336 | 4 | 1 |
| Micro Labs LimitedIndia | injection; injection, solution | ANDAANDA205723, ANDA219845 | 3 | 5 |
| HF Acquisition Co LLCUnited States | injection; injection, solution | ANDAANDA040466, ANDA080817 | 3 | 1 |
| RemedyRepack, IncUnited States | injection | ANDAANDA080817, ANDA205336 | 3 | 1 |
| Cardinal Health 418, Inc.United States | injection; injection, solution | ANDAANDA040466, ANDA080817 | 2 | 34 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA080817 | 2 | 4 |
| International Medication Systems, Ltd.United States | injection | ANDAANDA080817 | 2 | 3 |
| Camber Pharmaceuticals, Inc.United States | solution | ANDAANDA219470 | 2 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection | ANDAANDA205336, ANDA205337 | 2 | 1 |
| PAI Holdings, LLCUnited States | solution | ANDAANDA087513 | 2 | 1 |
| GLAND PHARMA LIMITEDIndia | injection | ANDAANDA218448 | 1 | 4 |
| ProPharma Distribution, LLC.United States | injection, solution | ANDAANDA205723 | 1 | 3 |
| Henry Schein, Inc.United States | injection | ANDAANDA080817 | 1 | 1 |
| Armas Pharmaceuticals, Inc. | injection, solution | ANDAANDA205723 | 1 | 0 |
| Avenacy, Inc. | injection, solution | ANDAANDA205336 | 1 | 0 |
| Redmont Pharmaceuticals, LLC | solution | ANDAANDA087513 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA218448 | 1 | 0 |
| Sportpharm LLC | injection | ANDAANDA080817 | 1 | 0 |
Bulk ingredient listings
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 1 NDC
- Kongo Chemical Co., Ltd.Japan · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- QIDONG DONGYUE PHARMACEUTICAL CO., LTD.China · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Supriya Lifescience LimitedIndia · 1 NDC
- Swati Spentose Pvt. Ltd.India · 1 NDC
- Wanbury LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes diphenhydramine hydrochloride?
- 19 companies list diphenhydramine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Fresenius Kabi USA, LLC, Medical Purchasing Solutions, LLC, Micro Labs Limited, HF Acquisition Co LLC, RemedyRepack, Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic diphenhydramine hydrochloride?
- 19 companies list diphenhydramine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies diphenhydramine hydrochloride active ingredient?
- 9 companies list diphenhydramine hydrochloride as a bulk ingredient, including ASCLEMED USA INC. DBA ENOVACHEM, Kongo Chemical Co., Ltd., MEDISCA Inc., Professional Compounding Centers of America dba PCCA.