Composition
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DIPHENHYDRAMINE HYDROCHLORIDE 25MG · CapsuleNDA005845-007 · Discontinued
- DIPHENHYDRAMINE HYDROCHLORIDE 50MG · CapsuleNDA005845-001 · Discontinued
- DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML · ElixirThis page
- DIPHENHYDRAMINE HYDROCHLORIDE 10MG/ML · InjectableNDA006146-001 · Discontinued
- DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableNDA006146-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA005845.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Benadryl
- Active substance
- diphenhydramine hydrochloride
- Route
- Oral
- Dosage form
- Elixir
- Applicant
- Mcneil Cons
- Status
- Discontinued
- FDA approval
- 4 Mar 1946
- Application
- NDA005845-004