Drugplain

Nighttime Sleep Aid 25 mg/1

Diphenhydramine HCl 25 mg · TABLET, COATED · Health Pharma USA LLC

No Recall History
Plain English

Nighttime Sleep Aid is an over-the-counter oral tablet containing diphenhydramine, an antihistamine used to help relieve occasional sleeplessness. Each coated tablet contains 25 mg of the active ingredient.

Key Facts

Brand Name
Nighttime Sleep Aid
Generic Name
Diphenhydramine HCl 25 mg
NDC Code (Product)
71679-110
Manufacturer
Health Pharma USA LLC
Strength
25 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
06/18/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue4,100 reports
drug ineffective3,697 reports
pain3,582 reports
headache3,548 reports
off label use3,491 reports
nausea3,237 reports
infusion related reaction3,230 reports
arthralgia3,150 reports
pneumonia2,656 reports
nasopharyngitis2,603 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage & Administration

Directions take only one dose (30 mL) per day (24 hours) only use dose cup provided adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor children under 12 yrs do not use

Warnings

Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin

Frequently Asked Questions

What is Nighttime Sleep Aid used for?

Nighttime Sleep Aid is an over-the-counter oral tablet containing diphenhydramine, an antihistamine used to help relieve occasional sleeplessness. Each coated tablet contains 25 mg of the active ingredient.

Is Nighttime Sleep Aid a controlled substance?

Nighttime Sleep Aid is not classified as a controlled substance by the DEA.

What is the generic name for Nighttime Sleep Aid?

The generic name for Nighttime Sleep Aid is Diphenhydramine HCl 25 mg. There are 8 other brand versions of Diphenhydramine HCl 25 mg.

What is the NDC code for Nighttime Sleep Aid 25 mg/1?

The NDC (National Drug Code) for Nighttime Sleep Aid 25 mg/1 is 71679-110, listed by Health Pharma USA LLC.

Product NDC

71679-110

Package NDC

71679-110-03

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)