Drugplain

Nighttime Sleep Aid 50 mg/30mL

Diphenhydramine Hydrochloride · LIQUID · Grocery Outlet, Inc.

2 Recalls on Record
Plain English

Nighttime Sleep Aid is a liquid containing diphenhydramine hydrochloride at 50 mg/30mL, taken oral. Manufactured by Grocery Outlet, Inc..

Key Facts

Brand Name
Nighttime Sleep Aid
Generic Name
Diphenhydramine Hydrochloride
NDC Code (Product)
85828-793
Manufacturer
Grocery Outlet, Inc.
Strength
50 mg/30mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
03/12/2026

Recall History

2 Recalls on Record
Class II03/04/2025

Chattem Inc

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

OngoingVoluntary: Firm initiated
Class III08/04/2022

LNK International, Inc.

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue4,098 reports
drug ineffective3,697 reports
pain3,581 reports
headache3,547 reports
off label use3,489 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 contains Diphenhydramine Hydrochloride. It is a liquid taken oral. Consult your doctor for specific uses.

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 Hydrochloride. There are 11 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for Nighttime Sleep Aid 50 mg/30mL?

The NDC (National Drug Code) for Nighttime Sleep Aid 50 mg/30mL is 85828-793, listed by Grocery Outlet, Inc..

Product NDC

85828-793

Package NDC

85828-793-01

Other Nighttime Sleep Aid Dosages

Other Diphenhydramine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)