Drugplain

Cough Drops 5.8 mg/1

Cherry · PASTILLE · United Natural Foods, Inc.

10 Recalls on Record
Plain English

Cough Drops is a pastille containing cherry at 5.8 mg/1, taken oral. Manufactured by United Natural Foods, Inc..

Key Facts

Brand Name
Cough Drops
Generic Name
Cherry
NDC Code (Product)
83455-202
Manufacturer
United Natural Foods, Inc.
Strength
5.8 mg/1
Dosage Form
PASTILLE
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
05/12/2023

Recall History

10 Recalls on Record
Class I03/02/2021

A-S Medication Solutions LLC.

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

TerminatedVoluntary: Firm initiated
Class II03/20/2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

OngoingVoluntary: Firm initiated
Class III04/27/2022

Bestco LLC

Subpotent drug: Low OOS for menthol content at the three month room temperature.

TerminatedVoluntary: Firm initiated
Class II01/19/2024

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

TerminatedVoluntary: Firm initiated
Class II03/20/2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

OngoingVoluntary: Firm initiated
Class II03/20/2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

OngoingVoluntary: Firm initiated
Class II03/20/2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

OngoingVoluntary: Firm initiated
Class II01/19/2024

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

TerminatedVoluntary: Firm initiated
Class II03/20/2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

OngoingVoluntary: Firm initiated
Class III07/02/2015

Bestco, Inc.

Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue103 reports
dyspnoea99 reports
off label use98 reports
drug ineffective96 reports
pain87 reports
cough85 reports
dizziness80 reports
headache80 reports
pruritus77 reports
diarrhoea75 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat

Dosage & Administration

Directions adults and children 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 5 years - ask a doctor

Warnings

Warnings Sore throat warning: if sor throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Frequently Asked Questions

What is Cough Drops used for?

Cough Drops contains Cherry. It is a pastille taken oral. Consult your doctor for specific uses.

Is Cough Drops a controlled substance?

Cough Drops is not classified as a controlled substance by the DEA.

What is the generic name for Cough Drops?

The generic name for Cough Drops is Cherry. There are 11 other brand versions of Cherry.

What is the NDC code for Cough Drops 5.8 mg/1?

The NDC (National Drug Code) for Cough Drops 5.8 mg/1 is 83455-202, listed by United Natural Foods, Inc..