Drugplain

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops 5.4 mg/1

Menthol · LOZENGE · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

10 Recalls on Record
Plain English

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops is a lozenge containing menthol at 5.4 mg/1, taken oral. Manufactured by Xiamen Kang Zhongyuan Biotechnology Co., Ltd..

Key Facts

Brand Name
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops
Generic Name
Menthol
NDC Code (Product)
83698-110
Manufacturer
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Strength
5.4 mg/1
Dosage Form
LOZENGE
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/21/2024

Recall History

10 Recalls on Record
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 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 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 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

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves: • cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Dosage & Administration

Directions • adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor • children under 2 years of age: ask a doctor

Warnings

Warnings Sore throat warning: If sore 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. Ask a doctor before use if you have • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage Stop use and ask a doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens Keep this and all drugs out of the reach of children.

Frequently Asked Questions

What is MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops used for?

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops contains Menthol. It is a lozenge taken oral. Consult your doctor for specific uses.

Is MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops a controlled substance?

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops is not classified as a controlled substance by the DEA.

What is the generic name for MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops?

The generic name for MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops is Menthol. There are 12 other brand versions of Menthol.

What is the NDC code for MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops 5.4 mg/1?

The NDC (National Drug Code) for MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops 5.4 mg/1 is 83698-110, listed by Xiamen Kang Zhongyuan Biotechnology Co., Ltd..