NDC 0121-0489
Diphenhydramine Hydrochloride 12.5 mg per 5 mL solution
On the label: Pharmaceutical Associates, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | Greenville, SC, United States | Makes it | No problems foundAug 1, 2025 · 18 inspections, 1 with FDA action |
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diphenhydramine: every company that makes it
- Form
- solution, oral
- Strength
- 12.5 mg per 5 mL
- Approval
- ANDA ANDA087513
- On the market since
- Feb 10, 1982
- Package NDCs
0121-0489-000121-0489-05- Official label
- DailyMed (National Library of Medicine), updated Apr 5, 2024
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