Drugplain

Sleep Aid 10 [hp_X]/59mL

Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Pulsatilla, and Valeriana officinalis. · LIQUID · King Bio Inc.

9 Recalls on Record
Plain English

This over-the-counter liquid sleep aid contains a combination of herbal and homeopathic ingredients intended to help with sleep. It is taken by mouth and is available without a prescription.

Key Facts

Brand Name
Sleep Aid
Generic Name
Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Pulsatilla, and Valeriana officinalis.
NDC Code (Product)
57955-9986
Manufacturer
King Bio Inc.
Strength
10 [hp_X]/59mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Drug Class
Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]
Marketing Start
03/15/2026

Recall History

9 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 II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: 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
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use11,113 reports
fatigue8,415 reports
headache7,902 reports
drug ineffective7,280 reports
nausea7,166 reports
pain6,961 reports
infusion related reaction6,073 reports
arthralgia5,771 reports
toxicity to various agents5,498 reports
dyspnoea5,350 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps to reduce difficulty in falling asleep

Dosage & Administration

Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use

Warnings

Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Sleep Aid used for?

This over-the-counter liquid sleep aid contains a combination of herbal and homeopathic ingredients intended to help with sleep. It is taken by mouth and is available without a prescription.

Is Sleep Aid a controlled substance?

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

What is the generic name for Sleep Aid?

The generic name for Sleep Aid is Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Pulsatilla, and Valeriana officinalis.. There are no other listed brand versions of Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Pulsatilla, and Valeriana officinalis..

What is the NDC code for Sleep Aid 10 [hp_X]/59mL?

The NDC (National Drug Code) for Sleep Aid 10 [hp_X]/59mL is 57955-9986, listed by King Bio Inc..

Product NDC

57955-9986

Package NDC

57955-9986-2

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

Data from openFDA · Public domain (CC0 1.0)