Diphenhydramine Hydrochloride is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Nighttime Sleep Aid, Nighttime Sleep-Aid, Sleep Aid Nighttime, Benadryl, Banophen, M-Dryl, Rest Simply, Geri-Dryl allergy relief, Allergy Relief Dye Free, Good Neighbor Pharmacy Childrens Allergy, Sleep-Aid, SleepAid Softgels
- Taken
- Oral
- Label
- Raritan Pharmaceuticals Inc, revised September 9, 2026 · full label on DailyMed
Purpose
Nighttime sleep-aid
What it is used for
▪ for the relief of occasional sleeplessness ▪ reduces time to fall asleep if you have difficulty falling asleep
Active ingredient
Diphenhydramine HCl 50 mg
Do not use
▪ for children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
▪ a breathing problem such as emphysema, or chronic bronchitis ▪ glaucoma ▪ difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
▪ avoid alcoholic beverages
Stop use and ask a doctor if
sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
Warnings
Do not use ▪ for children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have ▪ a breathing problem such as emphysema, or chronic bronchitis ▪ glaucoma ▪ difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product ▪ avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Pregnancy or breastfeeding
If pregnant or breast-feeding , ask a health professional before use.
Keep out of reach of children
.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Diphenhydramine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class III Ongoing
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot: KDC0224001B Exp 09/30/2026
- Distribution
- Nationwide in the US
- Quantity
- 324 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0199-2025
-
Class III Ongoing
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot: KDC0124002B Exp 09/30/2026
- Distribution
- Nationwide in the US
- Quantity
- 456 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0198-2025
-
Class III Ongoing
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot: KDC0124001A Exp 09/30/2026.
- Distribution
- Nationwide in the US
- Quantity
- 7198 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0197-2025
-
Class II Ongoing
Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lots, distribution and details
- Lots / codes
- A3804 Exp 12/31/13
- Distribution
- Nationwide and PR
- Quantity
- 1
- Recall started
- May 29, 2013 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-723-2013
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Diphenhydramine Hydrochloride
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 303d7651-9c8f-4a14-9f2c-7181fa0f003e.