Drugplain

Benadryl 25 mg/1

Diphenhydramine Hydrochloride · TABLET, FILM COATED · Kenvue Brands LLC

4 Recalls on Record
Plain English

Benadryl is a tablet, film coated containing diphenhydramine hydrochloride at 25 mg/1, taken oral. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
Benadryl
Generic Name
Diphenhydramine Hydrochloride
NDC Code (Product)
50580-226
Manufacturer
Kenvue Brands LLC
Strength
25 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
09/01/2008

Recall History

4 Recalls on Record
Class II10/19/2015

Western Drug

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue11,343 reports
off label use10,608 reports
nausea9,930 reports
headache9,128 reports
pain8,058 reports
drug ineffective7,549 reports
pruritus7,530 reports
dyspnoea7,424 reports
infusion related reaction6,804 reports
rash6,599 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage & Administration

Directions find right dose on chart below mL = milliliter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Warnings

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Frequently Asked Questions

What is Benadryl used for?

Benadryl contains Diphenhydramine Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Benadryl a controlled substance?

Benadryl is not classified as a controlled substance by the DEA.

What is the generic name for Benadryl?

The generic name for Benadryl is Diphenhydramine Hydrochloride. There are 12 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for Benadryl 25 mg/1?

The NDC (National Drug Code) for Benadryl 25 mg/1 is 50580-226, listed by Kenvue Brands LLC.